Section 7 Testing — Orthopedic Implant Testing Services

Services

Section 7 Testing has over 30 years of experience generating reports that sail through regulatory agencies such as the USFDA. Standards testing, custom testing, and advanced computational product development are our specialties.

Standards

ISO

7206
8827
11491
14242
14879
15142
18192
22622
23089

ASTM

F382
F384
F543
F564
F1223
F1264
F1357
F1378
F1541
F1714
F1717
F1781
F1798
F1800
F1814
F1820
F1829
F1875
F2009
F2028
F2077
F2180
F2193
F2267
F2345
F2346
F2423
F2502
F2580
F2582
F2624
F2665
F2706
F2723
F2724
F2777
F2979
F3090
F3129
F3140
F3143
F3210
F3295
F3437
F3446
F3495
F3574
F3631
F3690
F3738

Custom

Regulatory deficiency letters
Small joints
Fixation

Computational

All virtual tests accepted by USFDA, many predicates
F1223
F2996
F3161
F3334
KneeSIM range of motion
Contact area and stress

Anatomy Bundles

Most clients need a battery of tests to clear a single implant. S7T offers bundle pricing on combined mechanical, wear, and computational programs by anatomy.

- ISO 14879 Total knee-joint prostheses: endurance properties of knee tibial trays
- ASTM F1223 Determination of Total Knee Replacement Constraint
- ASTM F1800 Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
- ASTM F1814 Evaluating Modular Hip and Knee Joint Components
- ASTM F2723 Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
- ASTM F2724 Evaluating Mobile Bearing Knee Dislocation
- ASTM F2777 Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
- ASTM F3140 Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
- ASTM F3161 Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
- ASTM F3210 Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
- ASTM F3334 Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
- ASTM F3495 Determining the Static Failure Load of Ceramic Knee Femoral Components
- ISO 7206 Partial and total hip joint prostheses
- ISO 11491 Determination of impact resistance of ceramic femoral heads for hip joint prostheses
- ISO 14242 Wear of total hip-joint prostheses
- ASTM F1714 Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
- ASTM F1814 Evaluating Modular Hip and Knee Joint Components
- ASTM F1820 Determining the Forces for Disassembly of Modular Acetabular Devices
- ASTM F1875 Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
- ASTM F2009 Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
- ASTM F2345 Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
- ASTM F2580 Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses
- ASTM F2582 Dynamic Impingement Between Femoral and Acetabular Hip Components
- ASTM F2979 Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
- ASTM F2996 Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
- ASTM F3090 Fatigue Testing of Acetabular Devices for Total Hip Replacement and Performance Requirements
- ASTM F3129 Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
- ASTM F3143 Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
- ASTM F3446 Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
- ASTM F3738 Hip Simulator Wear Testing of Metal-on-Polyethylene Articulations Under Adverse Conditions Using Third-Body Particles
- ISO 18192 Wear of total intervertebral spinal disc prostheses
- ISO 23089 Preclinical mechanical assessment of spinal intervertebral body fusion devices
- ASTM F1717 Spinal Implant Constructs in a Vertebrectomy Model
- ASTM F1798 Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- ASTM F2077 Intervertebral Body Fusion Devices
- ASTM F2193 Components Used in the Surgical Fixation of the Spinal Skeletal System
- ASTM F2267 Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- ASTM F2346 Static and Dynamic Characterization of Spinal Artificial Discs
- ASTM F2423 Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
- ASTM F2624 Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
- ASTM F2706 Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
- ASTM F3295 Impingement Testing of Total Disc Prostheses
- ASTM F3574 Sacroiliac Joint Fusion Devices
- ASTM F3631 Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
- ASTM F1378 Shoulder Prostheses
- ASTM F1829 Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
- ASTM F2028 Dynamic Evaluation of Glenoid Loosening
- ISO 22622 Wear of total ankle-joint prostheses
- ASTM F2665 Total Ankle Replacement Prosthesis
- ISO 8827 Staples with parallel legs for orthopaedic use
- ISO 15142 Metal intramedullary nailing systems
- ASTM F382 Metallic Bone Plates
- ASTM F384 Metallic Angled Orthopedic Fracture Fixation Devices
- ASTM F543 Metallic Medical Bone Screws
- ASTM F564 Metallic Bone Staples
- ASTM F1264 Intramedullary Fixation Devices
- ASTM F1541 External Skeletal Fixation Devices
- ASTM F2180 Metallic Implantable Strands and Cables
- ASTM F2502 Absorbable Plates and Screws for Internal Fixation Implants
- ASTM F3437 Metallic Bone Plates Used in Small Bone Fracture Fixation
- ASTM F1357 Articulating Total Wrist Implants
- ASTM F1781 Elastomeric Flexible Hinge Finger Total Joint Implants
- ASTM F3690 Evaluating Suture Anchor Insertion and Pull Displacement Resistance

Why S7T

Predicate data. 25+ years of performance data on cleared devices — the comparison datasets your 510(k) needs.
FDA-accepted methods. Including the ORL-developed virtual ASTM F1223-14 protocol accepted in a 510(k) submission.
Standards authorship. Direct lineage from a lab that helped write the standards regulatory bodies use.
One vendor, three disciplines. Mechanical bench, wear simulators, and computational models in-house.