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Howmedica Osteonics Corp. dba Stryker Orthopaedics FDA Approvals
0 new drug approvals and 25 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System510(k)Aug 6, 2026Orthopedic |
| Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component510(k)Jul 10, 2026Orthopedic |
| Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert510(k)Feb 18, 2026Orthopedic |
| Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper510(k)Dec 15, 2025Orthopedic |
| Triathlon® Total Knee System - Triathlon® Gold Femoral Components510(k)Oct 24, 2025Orthopedic |
| Stryker and Serf hip devices510(k)Jul 25, 2025Orthopedic |
| Triathlon® Hinge Knee System510(k)Jul 25, 2025Orthopedic |
| Stryker Orthopaedics Hip Devices Labeling Update510(k)Feb 6, 2025Orthopedic |
| Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert510(k)Feb 6, 2025Orthopedic |
| Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System510(k)Dec 4, 2024Orthopedic |
| Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component510(k)Aug 2, 2024Orthopedic |
| 22.2mm BIOLOX® delta Ceramic V40 Femoral Heads510(k)Apr 24, 2024Orthopedic |
| Stryker Orthopaedics Hip Systems Labeling Update510(k)Apr 12, 2024Orthopedic |
| 28mm/38D MDM X3 Insert for MDM Liner510(k)Mar 11, 2024Orthopedic |
| Stryker Orthopaedics Hip Systems Labeling Update510(k)Dec 21, 2023Orthopedic |
| Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component510(k)Jun 2, 2023Orthopedic |
| Modular Rotating Hinge Knee Systems and Compatible Components510(k)Apr 21, 2023Orthopedic |
| Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee510(k)Jan 26, 2023Orthopedic |
| Triathlon® Hinge Knee System510(k)Jan 20, 2023Orthopedic |
| UHR Bipolar Implants, Restoration GAP II Implants510(k)Oct 21, 2022Orthopedic |
| Acetabular Dome Hole Plug510(k)Mar 9, 2022Orthopedic |
| Restoration® Modular Hip System510(k)Mar 1, 2022Orthopedic |
| Exeter® X3® RimFit® Cup510(k)Feb 1, 2022Orthopedic |
| Restoration Modular 115mm Conical Distal Stem510(k)Dec 21, 2021Orthopedic |
| Avon Patello-femoral Joint Prosthesis510(k)Jun 4, 2021Orthopedic |