ASTM F1264 Intramedullary Fixation Device Torsion & Bend Fatigue Test

Information on the most widely used ASTM standards within the materials testing industry

Descriptions of the most prominent lSO standards within the materials testing industry

Standards including EN, DIN, JlS, and more

Mechanical testing of polymer materials in the automotive industry is directly related to the safety of components and the reliability of the entire vehicle. UnitedTest can cover mechanical performance testing for automotive interior and exterior parts, as well as functional components, adapting to automaker standards and providing comprehensive testing solutions including tensile, impact, and fatigue tests.

Mechanical testing in the battery industry determines the tensile and puncture resistance of core components such as separators and electrodes, directly affecting battery safety and cycle life. UnitedTest can cover full-dimensional mechanical testing of battery materials, compatible with national and international standards, and provide customized testing solutions.

Mechanical testing in the consumer goods industry determines product durability and safety, such as impact resistance for toys and fatigue resistance for home appliances, making it core to compliance and quality. UnitedTest can cover mechanical tests for all categories of consumer goods, including tensile, impact, and hardness tests, compatible with national and international standards, and offers customized testing solutions.

In the field of medical and biomedical sciences, mechanical testing determines the safety and compatibility of implanted devices and biomaterials, making it a core part of regulatory approval. UnitedTest can cover a full range of tests including tensile, fatigue, and wear tests, compatible with national and international standards, and provides customized biomechanical testing solutions.

Material strength is a course that most engineering fields are required to study in university education. This interesting course is very practical and makes use of testing equipment in the materials laboratory.

Mechanical testing of industrial products and components is essential to ensure their load-bearing, fatigue resistance, and impact resistance, directly preventing production accidents and ensuring stable operation of equipment. UnitedTest can cover a full range of tests including tensile, hardness, and fatigue, complying with national and international standards, and provides customized industrial mechanical testing solutions.

Mechanical testing in the plastic pipe industry determines ring stiffness, impact resistance, and tensile performance, directly preventing pipe bursts and deformation risks. UnitedTest can cover full-dimensional mechanical testing of pipes, complies with ISO,ASTM,EN et.c, international standards, and provides customized testing solutions.

In the construction engineering and building materials industry, mechanical testing determines the compressive and tensile properties of materials such as concrete and steel, which is core to ensuring the safety and durability of buildings. UnitedTest can cover the full range of building material mechanical tests, complies with ISO, ASTM international standards, and provides customized testing solutions for compressive, tensile, and other properties.

Mechanical testing in the food and beverage industry involves the compressive and tensile performance of packaging and the safety of food texture, directly ensuring storage, transportation safety, and the eating experience. UnitedTest can cover all-dimensional mechanical testing for packaging and food texture, comply with national and international standards, and provide customized testing solutions.

Mechanical testing in the packaging industry determines the packaging's resistance to compression, impact, and tension, directly ensuring the safety of contents during storage and transportation. UnitedTest can cover comprehensive mechanical testing for packaging, complying with ISO, ASTM Standards, and provides customized testing solutions for compression, drop, tear, and more.

Mechanical testing in the transportation industry concerns the load-bearing and fatigue resistance performance of core components such as vehicles, tracks, and containers, directly ensuring transport safety and equipment durability. UnitedTest can cover mechanical testing for all types of transportation materials, complying with national and international standards, and provides customized testing solutions including tensile, fatigue, and impact tests.

Metallurgical testing examines the properties of metallic materials to determine if a particular metal is appropriate for its intended use.

Testing of polymer materials covers mechanical, thermal, and chemical properties, verifying strength, heat resistance, composition, and ensuring product quality and compliance.

UnitedTest offer world-class testing solution in testing for polymeric materials, including elastomers, thermoplastics, composites, coatings, and structural adhesives in a variety of industries.

Testing of rubber and elastomers is used to assess the various properties and performance of materials under different conditions. This is crucial for ensuring the safety, functionality, and quality of rubber and elastomer products used in industries such as automotive, construction, consumer goods, and aerospace.

Conduct adhesive testing using various testing methods to determine their performance and characteristics in applications across multiple industries such as aerospace, automotive, construction, packaging, industrial, medical, and energy, thereby supporting application development and quality assurance.

UnitedTest supply machine and testing solution for tension, compression, fracture toughness, direct shear, triaxial and ultrasonic velocity are common concrete and rock testing applications.

UnitedTest has helped a number of companies involved in the wood, paper, cardboard, and corrugated industry with their testing needs. Our materials testing systems are capable of testing raw materials, components, and finished products.

UnitedTest testing system is trusted by leading medical device manufacturers, universities, and medical research laboratories worldwide. Whether testing tissues or bioresorbable materials, stents, or sutures, UnitedTest offers a variety of single-actuator and dual-actuator systems to meet your biomedical testing needs.

Mechanical testing in the textile fabric industry determines core properties such as fabric tensile strength, tear resistance, and wear resistance, directly affecting product durability and safety. UnitedTest can cover comprehensive mechanical tests for textiles, complying with national standards / ISO standards, and provides customized testing solutions including tensile, tear, and puncture tests.

The mechanical testing of industrial components directly determines the load-bearing, fatigue resistance, and wear resistance of the parts, helping to avoid equipment failure risks. UnitedTest can cover a full range of tests including tensile, hardness, and fatigue, is compatible with ISO/ASTM/GB standards, and provides customized mechanical testing solutions for industrial components.

Mechanical testing in the glass-ceramics industry determines core properties such as flexural strength, hardness, and fracture toughness, directly helping to avoid brittleness and failure risks. UnitedTest can cover comprehensive testing for flexural strength, hardness, and fracture toughness, compatible with national and ISO/ASTM standards, and provides customized testing solutions.

Tensile test evaluates material resistance to stretching, measuring strength/elongation critical for quality control. UnitedTest offers universal tensile testers (10-600KN) compliant with ASTM/ISO standards, providing tailored solutions for metals, polymers, medical & industrial materials.

Compression test assesses material resistance to compressive loads, measuring strength/deformation critical for quality validation. UnitedTest offers compression testing machines compliant with ASTM/ISO standards, providing tailored solutions for concrete, plastics, metals and industrial components.

Flexural & Bend tests evaluate material resistance to bending forces, measuring strength, stiffness and ductility for quality assurance. UnitedTest provides flexural testing machines (3-point/4-point bend) compliant with ASTM/ISO standards, offering tailored solutions for composites, plastics, metals and construction materials.

Torsion Test evaluates material resistance to rotational forces, measuring torsional strength/ductility critical for fasteners, insulators, shafts. UnitedTest offers torsion testers compliant with ASTM A938/ISO 16047, providing tailored solutions for automotive, aerospace, fastener industries.

Fatigue Test assesses material durability under cyclic loading, critical for predicting service life of industrial components. UnitedTest offers fatigue testing systems (axial/bending/torsion) compliant with ASTM E466/ISO 12106, providing tailored solutions for automotive, aerospace and manufacturing sectors.

Peel Test measures material adhesion strength by evaluating resistance to peeling forces, critical for adhesives, films, packaging. UnitedTest offers peel testers compliant with ASTM D903/ISO 8510, covering 90°/180° peel tests, and tailored solutions for packaging, automotive, textile industries.

Impact Test evaluates material resistance to sudden shock loads, critical for assessing toughness and fracture risk. UnitedTest offers impact testers (Charpy/Izod/fall weight) compliant with ASTM E23/ISO 148, providing tailored solutions for metals, plastics, glass and industrial components.

Tear & Shear Test evaluates material resistance to tearing and shearing forces, measuring critical strength parameters for quality control. Tear tests (Elmendorf/trouser/trapezoidal) assess resistance to crack propagation in films/fabrics, while shear tests measure resistance to parallel forces in joints/bolts. UnitedTest provides universal testing machines (10KN-600KN) with specialized fixtures for both tests, compliant with ASTM D624/D3164 and ISO standards, serving automotive, packaging and construction industries.

Hardness test measures material's resistance to permanent indentation, critical for quality control. UnitedTest offers universal hardness testers (Rockwell/Brinell/Vickers) compliant with ASTM/ISO standards, plus tailored hardness testing solutions for diverse industrial needs.

Biaxial/triaxial tests evaluate material performance under multi-axis loads, critical for biomaterials, metals and composites. UnitedTest provides compliant testing machines (ASTM/ISO) for planar biaxial, static/fatigue triaxial tests, with tailored solutions for industrial & biomedical needs.

Friction and wear tests assess material resistance to friction, abrasion and wear, critical for industrial material performance validation. UnitedTest offers tribometers compliant with ASTM G99/ISO standards, covering pin-on-disk, four-ball tests, and tailored friction & wear testing solutions for diverse industries.

Pressure test evaluates material/component resistance to static/dynamic pressure, critical for sealing, strength and safety validation. UnitedTest offers pressure testing machines compliant with ASTM/ISO standards, covering burst, hold-pressure tests, and tailored solutions for industrial, automotive & medical sectors.

Fire test assesses material flammability, heat resistance and fire-retardant performance, critical for safety compliance across industries. UnitedTest offers fire testing equipment compliant with ASTM/ISO/UL standards, providing tailored fire test solutions for building materials, plastics and industrial components.

Non-destructive Test (NDT) evaluates material/component integrity without damage, critical for safety & quality across industries. UnitedTest offers ultrasonic/X-ray/magnetic particle NDT equipment compliant with ASTM/ISO standards, plus tailored NDT solutions for aerospace, automotive & manufacturing sectors.

ASTM F1264 Intramedullary Fixation Devices Tester | UnitedTest

ASTM F1264 covers specifications and mechanical test methods for intramedullary fixation devices, intramedullary nails and rods for skeletal fracture fixation. UnitedTest manufactures ASTM F1264 compliant testing machines for orthopedic implant mechanical performance evaluation.

ASTM F1264 provides standard specification and test methods for intramedullary fixation devices (IMFDs) for orthopedic fracture treatment. The standard defines unified terminology, product classification, material requirements, marking and labeling rules, plus four mandatory mechanical test annexes for intramedullary nails and rods applied in skeletal fracture fixation.

It is important to note ASTM F1264 does not set mandatory clinical performance thresholds. The mechanical tests generate comparative mechanical data for implant assessment instead of absolute clinical pass-fail criteria, supporting orthopedic implant R&D, batch quality inspection and product validation for medical device manufacturers and testing laboratories.

UnitedTest develops and manufactures high-precision ASTM F1264 intramedullary fixation device testing machines. Our test rigs meet the standard’s mechanical testing requirements, delivering repeatable and reliable test results for intramedullary nail performance verification, implant durability analysis and medical implant certification tests.

Key test methods list:

1, static four point bending test method (Annex A1),

2, static torsion test method (Annex A2),

3, bending fatigue test method (Annex A3),

4, bending fatigue test method for IMFD locking screws (Annex A4).

The UTDS series Dynamic/Fatigue Testing machine used for bone needle, bending intramedullary nail fatigue test is mainly used for biomechanical performance testing of various materials, including artificial blood vessels, soft tissues, bones, bone plates, and vertebrae Interfusion device, knee joint, spine Dynamic and static mechanical tests on materials such as column fixators, metal coatings, hip joints, and intramedullary nails, including tension, compression, bending, and torsion.

ASTM F1264 Intramedullary Fixation Device Torsion

Core Scope and Objectives

Applicable Scope: It applies to intramedullary fixation devices designed for surgical fixation of the human skeletal system. These devices are inserted into the medullary cavity of bones and fixed with locking screws to treat fractures. Notably, users do not need to apply all the test methods in the standard; instead, they can select appropriate tests based on the specific design of the device.

Core Objectives: The standard aims to characterize the design and mechanical functions of IMFDs. It provides unified test methods to measure key properties like bending strength, torsional stiffness, and fatigue resistance. This helps manufacturers optimize product designs, assists quality inspection agencies in conducting standardized evaluations, and offers a reliable basis for regulatory authorities to review the safety of orthopedic devices. It should be emphasized that it does not specify device performance levels or predict clinical outcomes in individual patients, as such predictions require more personalized clinical data.

Four Key Test Methods

The standard includes four core test methods in its annexes, each targeting different mechanical performance aspects of IMFDs:

Test Method	Specific Procedures	Key Calculations/Outcomes
Static Four-Point Bending Test	Place the prepared IMFD specimen on a four-point bending fixture. Apply a compressive load at a constant displacement rate and record the load-displacement curve throughout the process.	Calculate the bending strength and bending structural stiffness of the device, which reflect its ability to resist bending deformation under static loads during fracture fixation.
Static Torsion Test	Secure the straight and uniform section of a specified-length IMFD specimen in a torsion testing system. Apply a pure torsional moment to the specimen and record the resulting angular deflection as well as the torque-rotation curve.	Compute the torsional stiffness, evaluating the device’s resistance to twisting forces—critical for scenarios where the implanted area is subject to rotational stress (e.g., during limb movement).
Bending Fatigue Test for IMFDs	Mount the IMFD specimen on the four-point bending fixture of a fatigue testing system. Conduct a sinusoidal cyclic loading test at a specified frequency. The test stops when the specimen fails, reaches a set limit, or completes a predetermined number of cycles.	Determine the fatigue strength and fatigue life of the main IMFD body, assessing its durability under repeated bending forces during long-term use.
Bending Fatigue Test for IMFD Locking Screws	Fix the locking screw specimen on a three-point or four-point bending fixture. Perform a sinusoidal cyclic test at the specified frequency until the screw fails or the test meets the preset termination conditions.	Calculate the fatigue strength and fatigue life of the locking screws. As a key component for securing the IMFD to bones, the fatigue resistance of these screws is vital to prevent implant loosening.

Recommended Equipment

To meet the test requirements, specific professional equipment is required, mainly including an UnitedTest universal testing machine (for static four-point bending and static torsion tests) and a UnitedTest dynamic fatigue testing machine (for the two fatigue tests). Matching fixtures are also essential, such as four-point bending fixtures for bending tests, torsion grips for torsion tests, and three-point bending fixtures for screw fatigue tests.

ASTM F1264 Intramedullary Fixation Device Torsion & Bend Fatigue Test details introductions:

Static Four-Point Bend Test Method—Annex A1.
This test method is intended to evaluate the bending strength or bending stiffness of the working length of the IMFD, and may not be appropriate for all situations. When the structurally critical region of the IMFD is shown to be located at the proximal or distal extremity of the IMFD, it may be necessary to evaluate the bending strength or bending stiffness of this region of the IMFD using a different test method. This is because it may not be physically possible to fit the proximal or distal extremity between the inner rollers of a four-point bend test. Structurally critical regions may be identified through such methods as hand calculations, finite element analysis, etc. Screw holes or other interlocking features are typically located at the proximal and distal extremities of an IMFD, and may result in structurally critical regions at these locations.
Static Torsion Test Method—Annex A2.
This test method covers the test procedure for determining the torsional stiffness of intramedullary fixation devices (IMFDs). The central part of the IMFD, with a straight and uniform cross-section and away from screw holes or other interlocking features, is tested in a static test.
Bending Fatigue Test Method—Annex A3.
This test method covers the test procedure for performing cyclic bending fatigue testing of intramedullary fixation devices (IMFDs). The central part of the IMFD, with a straight and uniform cross section and away from screw holes or other interlocking features, is tested in cyclic four-point bending. This method may be used to determine the fatigue life at a specified maximum bending moment or to estimate the fatigue strength for a specified number of cycles
Test Method for Bending Fatigue of IMFD Locking Screws—Annex A4.
This test method covers the test procedure for performing cyclic bending fatigue testing of locking screws used for the fixation of intramedullary fixation devices (IMFDs). The central part of the screw is tested in cyclic three-point or four-point bending. This method may be used to determine the fatigue life at a specified maximum bending moment or to estimate the fatigue strength for a specified number of cycles.

Key Test Parameters:

A1 Static Four‑Point Bend	Outer support span L: 100‑500 mm; inner loading span c ≤ L/3. Suggested short span: L = 114 mm, s = c = 38 mm; long span: L = 228 mm, s = c = 76 mm. Cross‑head displacement rate ≤ 1 mm/s. Test in anatomical AP and ML principal‑inertia planes. Minimum 3 specimens per group.
A2 Static Torsion	Gauge length nominally 230 mm; rotation rate 5 °/min; small pre‑compression axial load (5‑10 N). Test until ~5° angular rotation for elastic‑slope capture.
A3 IMFD Bending Fatigue	Sinusoidal cyclic loading; frequency ≤ 5 Hz; recommended load ratio R = 0.1. Span rules same as A1; run‑out default 1 000 000 cycles.
A4 Screw Bending Fatigue	Sinusoidal cyclic loading; frequency ≤ 5 Hz; recommended R = 0.1. Hardened rollers with diameter 2‑4 × thread pitch; rollers seat between adjacent screw thread crests.

Industrial‑Field Application

Orthopaedic medical‑device industry: R&D performance characterisation, design iteration, material comparison for intramedullary nails / rods for long‑bone fracture trauma fixation.

Regulatory submission support (FDA‑recognized consensus standard for orthopaedic implant pre‑market notifications).

Laboratory mechanical benchmarking between competing IMFD products.

Academic biomechanics research for intramedullary implant mechanical evaluation.

It covers solid‑section, hollow open‑section, hollow closed‑section IMFDs for acute fracture care and reconstructive orthopaedic surgery.

Related Standard:

ASTM F543	Standard Specification and Test Methods for Metallic Medical Bone Screws (used together with Annex A4 for locking‑screw evaluation)
ASTM F1611	Standard Specification for Intramedullary Reamers (related IMFD surgical instrument standard)FDA Access...
ASTM F383	Static Bend and Torsion Testing of Intramedullary Rods; many span set‑ups in F1264 are inherited from F383 practice. ASTM F383 describes a method for static bend and torsion testing of intramedullary rods for the determination of bending strength, bending rigidity, and torsional rigidity. But F383 is inactive, Withdrawn historical standard, replaced now mainly by ASTM F1264.
ISO 14630	Non‑active surgical implants‑general requirements for metallic orthopaedic implants (overarching international implant‑material baseline).
ISO 12189	Implants for surgery - Mechanical testing of implantable spinal devices - Fatigue test method for spinal implant assemblies using an anterior support
ISO 15142	Metal intramedullary nailing systems part 1 to 3
ASTM F124	Standard specification and test methods for intramedullary fixation devices

Keywords: ASTM F1264 intramedullary fixation device tester,intramedullary nail mechanical test machine,orthopedic implant testing equipment,skeletal fracture fixation device test rig,IMFD performance tester,medical intramedullary rod bending fatigue tester,orthopaedic implant quality control system,intramedullary implant laboratory test apparatus,fracture fixation device mechanical property analyzer,medical device material test machine,orthopedic implant R&D test equipment,implant batch validation tester,medical implant certification testing rig, IMFD four‑point bending equipment

Electronic Dynamic Universal Testing Machine/ Cyclic Testing Equipment widely used at material and components, parts dynamic mechanical property test, include tension, compression, low cycling test, match with high-low temperature chamber can execute the temperature test.

Electronic Fatigue Testing Machine designed for long-term cyclic load testing of metals, composites, and structural components, offering precise electronic control, repeatable results, and compliance with industrial standards.

Spinal Implant Constructs nail screw static and fatigue testing machine used to check the fatigue failure of medical nail, Loads are typically applied in a constant-amplitude, load-controlled sinusoidal waveform that runs more than 5 million times.

UnitedTest universal testing machine with various test fixture, like peel, flexure, puncture, tear, pneumatic grip, belt tension etc., can be used to almost all materials include but not limited to steel rod, rubber, steel wire, plastic, seat belt, textile, wood, panel etc., mechanical performance inspection.

The four point bending flexural test provides values for the modulus of elasticity in bending, flexural stress ,flexural strain and the flexural stress-strain response of the material. This test is very similar to the three point bending flexural test.

3 points bending grip used to measure the flexural modulus or flexural strength of a plastic material, conform with stanard ASTM D790, ISO 178.

Torsion tester is mainly used to execute torsion test for various kinds materials, manual loading, high accuracy torsion transducer to measure torque, photoelectric encoder to measure torsion angle, digital display test result. Easy to operate and with budgetary price, most suitable for research institute and colleague, factory laboratory etc. to check the torsion character of different materials.

Q1: What is ASTM F1264‑24? Why is this standard important?

A: ASTM F1264‑24 is the latest ASTM standard for intramedullary fixation devices (IMFD / intramedullary nails, rods). It defines terminology, material rules, marking‑labeling requirements and four mandatory‑annex mechanical test protocols: static four‑point bend, static torsion, IMFD body bending fatigue, locking‑screw bending fatigue. It delivers repeatable intrinsic mechanical data for implant R&D, material comparison, design iteration and regulatory submission (FDA 510(k) recognized consensus standard for long‑bone trauma implants). Benchmark data helps engineers evaluate yield strength, stiffness and fatigue risk before clinical use. It does NOT set clinical pass‑fail thresholds and cannot fully predict real‑patient outcomes.

Q2: What's the Test Principle?

A: 1. Static Four‑Point Bend (A1)

Constant‑displacement‑rate compressive force is applied via two inner loading rollers onto an IMFD supported by two outer rollers. Uniform bending moment exists in the inner span region. Record load‑deflection curve. Compute yield bending moment M_y, ultimate bending moment M_MAX, structural bending stiffness EI_e from elastic slope F/y. Subtract fixture‑device compliance to isolate true specimen bending compliance.

2. Static Torsion (A2)

Both ends of straight uniform IMFD gauge section are rigidly gripped. Pure torsional moment is applied at constant angular rotation rate. Torque‑vs‑angular‑rotation curve is recorded. Elastic slope of curve gives torsional stiffness (N·m/deg).

3. IMFD Bending Fatigue (A3)

Sinusoidal cyclic four‑point bending loads are applied to IMFD gauge section under controlled R‑ratio. Record maximum bending moment and number‑of‑cycles‑to‑failure; construct M‑N or S‑N diagram. Run‑out condition is typically 1 × 10⁶ cycles.

4. Locking‑Screw Bending Fatigue (A4)

Sinusoidal cyclic three‑ / four‑point bending is applied to locking screw gauge section. Record moment and cycles‑to‑failure for generating M‑N / S‑N curves, evaluate median fatigue strength at target cycle number.

Q3: Must I run all four tests for every intramedullary nail product?

A: No. The standard explicitly allows selecting only relevant test subsets, provided you give written technical justification for test selection / omission. You only need to perform tests matching your device design and intended clinical loading conditions.

Q4: What properties cannot be measured via ASTM F1264 tests?

A: ASTM F1264 only tests intrinsic hardware performance (material‑geometry properties of the implant itself). It does not simulate bone‑implant interaction, biological response, pull‑out strength, screw‑nail inter‑lock performance or in‑vivo clinical outcomes. It does not cover small‑bone implants like metacarpal / phalanx nails unless modified and justified. It cannot give absolute clinical acceptance thresholds for individual patients.

Q5: Why run fatigue test at 1 000 000 cycles in ASTM F1264 Annex A3?

A: Typical fracture healing takes roughly 150 000‑250 000 physiological load cycles. The 1 000 000‑cycle run‑out setting provides a conservative safety margin to compare implant fatigue resistance for delayed‑healing clinical cases (non‑union, bone defects, infection). It is a comparative engineering threshold rather than a real‑life exact clinical cycle count.

Q6: Why these mechanical tests are important for IMFD materials?

A: Intramedullary nails act as temporary load‑bearing implants until bone fracture heals. Material and cross‑section geometry govern clinical‑relevant mechanical behaviours:

Bending stiffness EI_e: Controls load‑sharing between implant and healing bone‑callus. Too‑high stiffness may shield bone from physiological stress; too‑low stiffness generates excessive fracture‑site motion, risking delayed union or non‑union. F1264 quantifies stiffness for material‑design comparison.

Yield / ultimate bending moment: Characterise resistance against permanent plastic deformation or catastrophic fracture under overload events (secondary trauma). Ductility (gap between yield and ultimate moment) is clinically important: moderately ductile nails may bend rather than snap under accidental overload; brittle material‑design combinations risk sudden intra‑operative or post‑operative breakage.

Fatigue performance: In cases of delayed bone‑healing (infected non‑union, bone‑defect segmental loss), IMFD sustains millions of cyclic physiological loads before bone provides mechanical support. Fatigue tests (A3/A4) compare material and notch‑sensitivity performance, identifying risk of cyclic‑load‑induced crack initiation and fracture for both nail body and locking‑screw components.

Torsional stiffness: Resistance against rotational shear loads after fracture fixation, which influences fracture‑site rotational micromotion and bone‑healing quality.

The standard provides a repeatable common test framework, enabling objective comparison of different alloys (stainless steel, titanium‑family), cross‑section shapes and manufacturing variants, even though absolute clinical performance predictions cannot be derived purely from bench‑test data.

Q7: Why choose ASTM F1264 Intramedullary Fixation Device Testing Machine from UnitedTest?

A: UnitedTest is professional manufacturer of ASTM F1264‑24 intramedullary fixation device test machines. Our systems support static four‑point bend, static torsion & cyclic bending‑fatigue for intramedullary nails and locking‑screws for orthopedic implant R&D and regulatory compliance.

UnitedTest is an original equipment manufacturer specializing in orthopedic implant biomechanical test systems fully compliant with ASTM F1264‑24 Standard Specification and Test Methods for Intramedullary Fixation Devices (IMFDs).

Our multi‑function dynamic‑static test platforms complete the four core test workflows defined in ASTM F1264‑24 Annex A1‑A4: static four‑point bending test, static torsion test, intramedullary nail body bending‑fatigue test, and IMFD locking‑screw bending‑fatigue test.

Supported test outputs:‑ Static: yield bending moment, ultimate bending moment, structural bending stiffness EI_e, torsional stiffness, fixture‑device compliance correction. ‑ Fatigue: M‑N / S‑N curves, cycles‑to‑failure, median fatigue strength at 1 000 000 cycles, run‑out recording.

System highlights:‑ High‑precision load‑cell & torque transducer (accuracy ± 1 % full‑scale). ‑ Standard & custom‑machined test fixtures: four‑point bend rolling‑roller jigs, anti‑rotation guide shoes, torsion gripping chucks, three‑/four‑point bending fixtures for locking bone‑screws. ‑ Controlled loading parameters: displacement rate, sinusoidal cyclic frequency ≤ 5 Hz, adjustable R‑ratio, cycle counting & automatic stop on specimen fracture. ‑ Complete raw‑data logging for full ASTM‑compliant lab report generation for product development, design comparison and FDA‑recognized regulatory submission (510(k)).

Our test equipment serves orthopedic implant manufacturers, university biomechanics labs, and third‑party medical‑device test laboratories. Besides ASTM F1264‑24, UnitedTest systems support many other orthopedic standards including ASTM F543, ASTM F1717, ISO 14630, ISO 7206‑1 etc.

Contact UnitedTest for technical datasheet, fixture drawings and test‑method consultation for your intramedullary nail / locking‑screw projects.

We offer customization to meet your specific needs. Our expert team will collaborate with you to develop the perfect product for you