Prosthetic Testing
ATS FoC provides prosthetic testing according to ASTM and ISO standards. A prosthesis is a medical implant designed to replace a missing body part after traumatic injury, degradation, surgical removal, or at birth. Prosthetic designs can differ significantly based on the patient’s needs. Some patients require temporary prosthetics, while others need prosthetics capable of maintaining mechanical integrity throughout long-term use.
The ATS FoC tests prosthetics for the spine, extremities, joints, and mouth, such as:
- Finger joint replacement
- Glenoid locking mechanism
- Hip systems
- Patellar joint replacement
- Shoulder joint replacement
- TMJ joint replacement
- Total ankle systems
- Total artificial disc
- Total knee replacement
- Total wrist replacement
Why Do You Need to Test a Prosthetic?
The FDA heavily regulates which medical devices reach the market. To meet requirements for legal distribution, manufacturers hire third-party medical device testers such as the ATS FoC. A qualified third-party lab helps clients deliver their products to the market faster through efficient testing recognized by regulatory bodies. Our work helps ensure a prosthetic’s safe and reliable function.
In vitro testing subjects the prosthetic to isolated loads, stress, movements, and environmental factors resembling conditions in a body. We perform custom, non-standard, fatigue, and mechanical testing:
- Axial Compression
- Fatigue
- Instrument and life cycle
- Lot verification
- Shear
- Tensile
- Torsion
- Wear and Simulation
Standards-Based Prosthesis Testing
Our experts can design test methods to ASTM or ISO standards:
- ASTM F2694
- ASTM F2790
- ISO 10328
- ISO 18192-1
- ISO 7206-4, 6, and 8
To learn more about our orthopedic implant testing, click here.
About the ATS FoC
The ATS FoC is a nationwide network of consulting engineering, calibration, testing, and inspection firms. We operate multiple A2LA-accredited labs for medical device testing. Known for our high-quality customer service and thorough analysis, the ATS FoC helps clients make informed business decisions in a variety of industries. Our extensive capabilities enable us to meet our clients’ unique needs quickly and efficiently. In addition to testing in qualified labs, we can provide field services for many tests.
Please call +1 (888) 287-5227 or complete the form on this page to schedule prosthetic testing, and we will help evaluate if your medical device is ready for FDA submission.
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Medical Device Testing
ASTM Testing
- ASTM F1044 Shear Testing of CaP and Metallic Coatings
- ASTM F1160 Shear and Bending Fatigue of Coatings
- ASTM F1264 Intramedullary Fixation Device Testing
- ASTM F1357 Articulating Total Wrist Implant Testing
- ASTM F1378 Shoulder Prostheses Testing
- ASTM F1541 ESFD Testing
- ASTM F1672 Patellar Prosthesis Testing
- ASTM F1714 Gravimetric Wear Assessment of Prosthetic Hip Design in Simulator Device Testing
- ASTM F1717 Spinal Implant Testing
- ASTM F1781 Elastomeric Flexible Hinge Finger Total Joint Implants Testing
- ASTM F1798 Spinal Implant Subassembly Testing
- ASTM F1820 Modular Acetabular Device Strength Testing
- ASTM F1829 Glenoid Locking Mechanism Shear Testing
- ASTM F1875 Fretting Corrosion Testing of Hip Implant Interfaces
- ASTM 2009 Modular Prostheses Taper Connection Testing
- ASTM F2025 Wear Assessment of Polymeric Components
- ASTM F2028 Glenoid Loosening Testing
- ASTM F2077 Intervertebral Body Fusion Device Testing
- ASTM F2183 Small Punch Testing
- ASTM F2193 Spinal Fixation Components
- ASTM F2267 Measuring Subsidence of Intervertebral Fusion Devices
- ASTM F2346 Standard and Dynamic Testing of Artificial Intervertebral Discs
- ASTM F2423 Wear and Fatigue Testing of Total Disc Prostheses
- ASTM F2502 Absorbable Plate and Screw Testing
- ASTM F2554 CAS System Precision Testing
- ASTM F2624 Static, Dynamic, and Wear Testing of Extra-Discal Spinal Implants
- ASTM F2624 Spinal Implant Dynamic Testing
- ASTM F2694 Lumbar Total Facet Prosthesis Testing
- ASTM F2706 Spinal Implant Fatigue Testing
- ASTM F2789 Mechanical and Functional Characterization of Nucleus Devices
- ASTM F2790 Static and Dynamic Testing of Total Facet Prostheses
- ASTM F382 Metallic Bone Plates Testing
- ASTM F384 Angled Orthopedic Fixation Testing
- ASTM F543 Metallic Medical Bone Screw Testing
- ASTM F564 Metallic Bone Staple Testing
ISO Testing
- Biocompatibility Testing for Medical Devices ISO 10993
- ISO-10328 Structural Testing of Lower Limb Prosthetics
- ISO 10993 Biocompatibility
- ISO 10993 Biocompatibility Testing
- ISO 10993 Testing
- ISO 10993 Testing Lab
- ISO 18192-1 Wear Testing for Intervertebral Disc Prostheses
- ISO 12189 Fatigue Testing of Flexible Spinal Implants
Medical Device Testing
- Fatigue Testing Lab
- Implant Testing
- Material Testing Laboratory
- Material Device Regulatory Compliance Testing
- Medical Device Testing
- Medical Device Testing Certification
- Medical Device Materials Testing
- Medical Device Materials Testing Consulting
- Medical Device Mechanical Testing
- Medical Device Mechanical Testing Regulations
- Medical Device Performance Testing
- Medical Device Product Testing
- Medical Device Reliability Testing
- Medical Device Standards Testing
- Medical Device Standards Testing Certifications
- Medical Device Testing Companies
- Medical Device Testing Services
- Medical Device Testing Lab
- Medical Implant Testing Lab
- Orthopedic Device Testing
- Prosthetic Testing
- Prosthetic Testing Services