UHR Bipolar Implants, Restoration GAP II Implants
FDA 510(k) K222632 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics
510(k) numberK222632
Submission
- Device name
- UHR Bipolar Implants, Restoration GAP II Implants
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Mahwah, NJ, US - Received
- August 31, 2022
- Decision date
- October 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertMBH · Traditional | 02/18/2026SE |
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| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | 10/24/2025SE |
| K251665 | Triathlon® Hinge Knee SystemKRO · Traditional | 07/25/2025SE |
| K250989 | Stryker and Serf hip devicesLPH · Traditional | 07/25/2025SE |
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| K243784 | Stryker Orthopaedics Hip Devices Labeling UpdateLPH · Traditional | 02/06/2025SE |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…JWH · Traditional | 12/04/2024SE |
Questions and answers
When was UHR Bipolar Implants, Restoration GAP II Implants cleared by the FDA?
UHR Bipolar Implants, Restoration GAP II Implants (K222632) received a 510(k) decision of Substantially Equivalent on October 21, 2022, 51 days after the submission was received.
What is the product code of K222632?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.