# K222632: UHR Bipolar Implants, Restoration GAP II Implants

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Oct 21, 2022 after 51 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921308 (1994). 122 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K800207: Uhr UNIVERSAL6HIP Replacement, Osteonics Corp. (1980) Summary page 5.
- K980774: Osteonics Gap-II Restoration Acetabular Shells, Osteonics Corp. (1998) Summary page 5.
- K153345: Stryker Orthopaedics Hip Systems Labeling Update, Stryker Orthopaedics (2016) Summary page 5.
- K171768: Trident® II Acetabular System, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (2017) Summary page 5.

## Most influential descendants
- K233498: Stryker Orthopaedics Hip Systems Labeling Update (2023), 4 descendants of its own
- K243784: Stryker Orthopaedics Hip Devices Labeling Update (2025), 2 descendants of its own
- K261624: 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 Component (2026), 0 descendants of its own
- K250989: Stryker and Serf hip devices (2025), 0 descendants of its own
- K240418: Stryker Orthopaedics Hip Systems Labeling Update (2024), 0 descendants of its own

## Indications for use
Femoral head/neck fractures or non-unions. Aseptic necrosis of the femoral head. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations: Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. Salvage of failed total hip arthroplasty. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. Segmental and/or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum, using standard total hip replacement acetabular components and procedures.

Source page: https://510kreport.com/device/K222632
Methodology: https://510kreport.com/methodology