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Home >> Application >> By Standard >> ASTM >> ASTM E-F >> ASTM F1717 Spinal Implant Constructs Test

ASTM F1717 Spinal Implant Constructs Test

ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Modelis a fundamental standard for evaluating the static and fatigue mechanical performance of spinal implant assemblies. Unlike ISO 12189, which focuses on a single device(an interbody cage), ASTM F1717 tests the entire posterior spinal construct—typically rods, screws, and cross-connectors—stabilizing a segment where a vertebral body has been removed (a "vertebrectomy" or "corpectomy" model). It simulates worst-case spinal instability to assess the implant's ability to maintain alignment and support loads.

Test Principle:

The principle is to create a standardized, worst-case biomechanical model of spinal instability and measure the construct's response. By fixing the implant into the UHMWPE blocks separated by a defined gap (span length, L), the test:

Isolates the performance of the implant hardware itself.

Applies pure, calculable bending moments (M) and forces (F). For example, in compression bending, the bending moment on the rod is calculated as M = (F * L) / 2.

Quantifies stiffness, yield load, ultimate load, and run-out cycles (for fatigue) in a reproducible laboratory environment.

ASTM F1717 Test Method:

Static Test
Compression - bending	Apply axial compression and bending loads at a rate of 25 mm/min to measure stiffness, yield load, and ultimate load.
Tension - bending	Apply axial tension and bending loads to assess the implant’s performance under distraction.
Torsion	Apply a torque of up to 10 Nm (lumbar) or 2 Nm (cervical) to evaluate rotational stability.
Fatigue test	Apply sinusoidal cyclic compression - bending loads (frequency ≤15 Hz, load ratio R = 0.1) until 5 million cycles or failure.
Vertebrectomy model	No anterior support is provided; the implant bears the full load, which is a "worst - case" simulation that differs from ISO 12189’s anterior support model.

Test Equipment:

Equipment Type	Specific Requirements
Fatigue Testing machine	Servohydraulic or electromechanical, capable of static (load/displacement control) and cyclic loading, load capacity ≥25 kN (lumbar) or ≥5 kN (cervical), frequency ≤15 Hz
Load/torque cell	Load cell accuracy class 0.5; torque cell accuracy ±1% for torsion tests
Test fixture	UHMWPE test blocks (2 blocks for vertebrectomy) with implant - matching holes; fixtures for compression - bending, tension - bending, and torsion alignment; adjustable gap (lumbar: 50 mm; cervical: 20 mm) to simulate the missing vertebra.
Environmental chamber	Optional, for 37°C and simulated body fluid (saline/Ringer’s solution) to mimic in - vivo corrosion conditions.

Test Specimen Information:

Implant Construct: The complete assembly to be tested (e.g., two longitudinal rods, four pedicle screws, possibly cross-connectors).

Vertebral Body Analogs:Two UHMWPE blocks. Their standardized material properties (modulus, density) provide a consistent and repeatable substrate for screw purchase, eliminating the variability of human cadaver bone.

Dimensions: The standard specifies critical geometric parameters:

Block Size: 75mm x 50mm x 40mm.

Span Length (L):The distance between the inner screws (typically 76mm for a "long" model, simulating a complete vertebrectomy). This is the most critical variable as it determines the bending moment on the rods.

ASTM F1717 Spinal Implant Constructs Test

Test Application:

Comparative Evaluation: To compare different rod materials (titanium vs. cobalt-chrome vs. PEEK), diameters, screw designs, or cross-linking mechanisms.

Design Verification & Validation: A mandatory part of the design process for any posterior stabilization system.

Quality Control & Benchmarking: For lot-release testing or comparing against predicate devices.

Regulatory Submission: Required evidence for FDA 510(k), CE Mark (under MDR), and other global regulatory pathways.

ASTM F1717 Test Procedures:

Construct Assembly: The implant (rods, screws) is assembled and rigidly fixed into the two UHMWPE blocks according to the manufacturer's surgical technique. The span length (L) is meticulously measured and recorded.

Fixture setup: Install UHMWPE blocks with a standard gap (50 mm for lumbar, 20 mm for cervical).

Static testing:

Compression/tension - bending: Load at 25 mm/min until yield or fracture, and record load - displacement curves.

Torsion: Apply torque at 0.5°/s and measure rotational stiffness.

Fatigue testing:

Lumbar: 0.5–5 kN cyclic load (R = 0.1); cervical: 0.1–1 kN.

Load at ≤15 Hz until 5 million cycles or failure.

Data recording: Record yield load, ultimate load, stiffness, cycle count, and failure mode.

Result reporting: Submit comparative data (e.g., S - N curves) and failure analysis.

Related Standards:

Standard	Relationship
ISO 12189	Complementary; ASTM F1717 is for vertebrectomy (no anterior support, rigid implants), while ISO 12189 is for anterior support (flexible implants)
ASTM F2706	Extends to occipitocervical constructs, with similar vertebrectomy model but adjusted torque/load parameters
ASTM F1798	Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
ASTM F2193	Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
ISO 14879	General spinal implant mechanical testing requirements, which ASTM F1717 supplements with specific vertebrectomy test protocols
ASTM F2077	Static testing for interbody cages; ASTM F1717 focuses on posterior assemblies
FDA Recognized Standard	It is recognized for 510(k) submissions for spinal implants

Why the Test is Important for the Spine Device:

The ASTM F1717 test is critically important because it directly assesses the primary mechanical function of posterior spinal constructs: to provide immediate and lasting stability in an unstable spine segment.

Predicts Clinical Performance: It simulates the high-stress scenario of a corpectomy, where the implant must bear all physiological loads (compression, torsion, tension). A construct that performs poorly here is at high risk of failure in vivo.

Prevents Mechanical Failure: Identifies weak points in the construct design—whether it's screw loosening, rod bending/fracture, or set-screw slippage—before the device is ever implanted in a patient.

Ensures Safety & Efficacy: Regulatory bodies rely on data from this standardized test to ensure that marketed devices have a baseline level of mechanical integrity, protecting patients from catastrophic implant failures that could lead to revision surgery, nerve damage, or spinal deformity.

Drives Innovation: Provides a level playing field for comparing new, potentially improved technologies (e.g., minimally invasive systems, novel alloys) against established designs.

Related products and device

ASTM F1717 Spinal Implant Constructs Fatigue Testing Machine

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.

ASTM F1717 Spinal implants Tension, Compression testing Machine

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ASTM F1717 Spinal Implants Torsion Torque Tester

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Related Standard

ISO 12189 Tests on Screw and Rod Systems for the Spine –

ISO 12189: Implants for surgery. Mechanical testing of implantable spinal devices. Fatigue test method for spinal implant assemblies using an anterior support.

ISO 12189 is an international standard that specifies fatigue test methods for spinal implant assemblies (fusion or motion preservation) using anterior support, focusing on compression/flexion fatigue to evaluate static and dynamic strength, especially for flexible, dynamic implants.

ISO 6475 Bone Screw Torsion Breaking Torque Test Methods –

ISO 6475 Implants for surgery — Metal bone screws with asymmetrical thread and spherical under-surface — Mechanical requirements and test methods

ISO 6475 specifies mechanical test methods for determining breaking torque and rotation angle at failure of metal bone screws with asymmetrical threads and spherical under-surfaces, along with minimum mechanical requirements for stainless steel screws in Annex A. It is critical for validating torsional integrity to prevent intraoperative/surgical failure and ensure regulatory compliance.

ASTM F543 Metallic Medical Bone Screws Test Driving Torque, Pullout Load Self-Tapping –

ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F543 is a testing standard used in the biomedical industry that defines specifications for metallic medical bone screws. Bone screws are used in surgical procedures for securing implants, osteosynthesis devices, and fracture fixation plates to the skeletal system. In normal clinical use, a surgeon applies combined axial and torsional forces to implant a bone screw into the body. Bone screws are designated Class 2 FDA devices, requiring significant testing and analysis of mechanical properties prior to approval and release. It provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.

ISO 16402 Acrylic resin cement Flexural fatigue testing –

ISO 16402:2008, Implants for Surgery - Acrylic Resin Cement - Flexural Fatigue Testing of Acrylic Resin Cements Used in Orthopaedics, is an international standard dedicated to testing the flexural performance of acrylic resin bone cement applied in orthopedic surgeries. It plays a critical role in ensuring the long-term mechanical stability of bone cement, which is essential for the success of orthopedic implants.

Bone Cement Four-Point Bending Fatigue Test is primarily used to evaluate the fatigue performance of bone cement materials under four-point bending conditions. Specifically, it can conduct mechanical performance tests, such as fatigue durability and lifespan, on specimens of bone cement, biomaterials, surgical implant materials, and medical materials. By simulating real-world stress conditions, the tester assesses the bending strength, fatigue life, deformation characteristics, and performance of bone cement under various environmental conditions. These test results are crucial for ensuring the reliability and safety of bone cement in practical applications, aiding in product design optimization, production process improvement, and overall product quality enhancement.

ISO 14879-1 Fatigue test of metallic tibial trays of total knee joint replacement system –

ISO 14879 - 1 is a core international standard formulated by the International Organization for Standardization (ISO) for the mechanical performance evaluation of metallic tibial trays in total knee replacements (TKR). The standard covers two major types of tests: static mechanical testing (to evaluate the ultimate load - bearing capacity and stiffness of the tibial tray) and cyclic fatigue testing (to simulate long - term physiological loading and assess durability).

FAQs about ASTM F1717 Spinal Implant Vertebrectomy Model Test

Q1: What is the core purpose of ASTM F1717, and what makes it distinct from ISO 12189?

A: The core purpose of ASTM F1717 is to specify static and fatigue mechanical testing methods for posterior spinal implant assemblies in a vertebrectomy (corpectomy) model, simulating a worst-case scenario where a vertebral body is removed and the implant bears full spinal load without anterior column support.

Its key difference from ISO 12189 is the test model: ASTM F1717 uses an unsupported vertebrectomy setup (for rigid/semi-rigid fusion implants), while ISO 12189 uses an anterior support model (for flexible/motion-preserving implants). The two standards complement each other to cover the full range of spinal implant types.

Q2: What types of spinal implants are covered by ASTM F1717?

A: ASTM F1717 applies to posterior spinal implant assemblies designed for fusion, including:

Pedicle screw-rod systems (thoracolumbar and cervical)

Hook-rod systems

Hybrid screw-hook assemblies

Rigid interconnection devices for spinal fusion

It does not apply to flexible/motion-preserving implants (these are better tested via ISO 12189) or standalone interbody cages (covered by ASTM F2077).

Q3: Can ASTM F1717 test results predict clinical performance of spinal implants?

A: While it cannot fully replicate the complex in vivo environment (e.g., bone remodeling, patient activity levels, and soft tissue interactions), the test provides a reliable preclinical benchmark. Implants that pass the 5 million cycle fatigue test under ASTM F1717 conditions have a significantly lower risk of fatigue-related failure in clinical use—especially in high-load surgical cases. The results help surgeons select implants appropriate for severe spinal pathologies.

Q4: Why is it called a "vertebrectomy model"?

A: The test setup—with two vertebral body analogs (UHMWPE blocks) separated by a gap—simulates a spinal segment where the vertebral body and discs have been completely removed (a vertebrectomy or corpectomy). This represents the maximum possible instability and load on the implant, ensuring it is tested under the most demanding conditions.

Q5: How is ASTM F1717 different from a test on cadaver spines?

A: Cadaver tests are excellent for biofidelity, replicating complex anatomy and soft tissues. ASTM F1717 is designed for comparative mechanical evaluation. It removes biological variability (bone density, size) to allow a direct, fair "apples-to-apples" comparison of the hardware's intrinsic strength and stiffness.

Q6: From an engineering standpoint, why is this test so critical?

A: It isolates and quantifies the fundamental load-bearing capability of the implant construct. By calculating pure bending moments (M = F*L/2), engineers can determine the safety margin for rods and the strength of screw connections. This data is essential for finite element analysis (FEA) validation and for preventing catastrophic failures like rod fracture in patients.

Q7: Why are UHMWPE blocks used instead of real bone or other materials?

A: UHMWPE provides a standardized, homogeneous, and predictable material for screw anchorage. Its properties are consistent worldwide, allowing test results from different labs to be comparable. The goal is to test the implant, not the variability of bone quality.

Q8: What is the "Span Length (L)" and why is it the most important variable?

A: The Span Length is the distance between the inner screws anchoring the construct. It directly defines the lever arm and therefore the bending moment on the rods. A longer span length (e.g., 76mm for a "corpectomy model") creates a much larger bending moment for the same applied force, making the test far more severe. Reporting and controlling 'L' is mandatory for result interpretation.

Q9: What constitutes "failure" in static and fatigue testing?

A: * Static Test Failure: Ultimate load is the maximum load sustained before a major drop in the load-displacement curve. Failure modes include rod permanent deformation or fracture, screw breakage, or screw "plow" through the UHMWPE block.

Fatigue Test Failure: The construct is cycled at a specific load level (based on a % of static strength) for a target number of cycles (often 5 million, simulating several years of use). "Run-out" means it survived. Failure is defined as fracture of any component or permanent deformation exceeding a set limit (e.g., rod deformation > 3mm).

Q10: What is the biggest source of error or variability in an F1717 test setup?

A: Fixturing and Alignment. Imperfect alignment of the UHMWPE blocks or the loading axis can introduce unwanted shear or torsional forces during a "pure" compression bending test, invalidating the calculated bending moment. Precise, rigid fixtures and meticulous setup are critical.

Q11: What data and reporting are required?

A: The standard requires detailed reporting of:

Construct Description: Implant sizes, materials, and assembly torque.

Test Parameters: Span length (L), loading rate, load levels.

Results: Load-displacement curves, stiffness, yield load, ultimate load, cycles to failure.

Failure Analysis: Photos and description of the exact failure mode (e.g., "rod fracture at the thread root of the most cephalad screw").

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