510(k) K261624 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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
| Applicant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Jul 10, 2026 |
| Received | May 15, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261624
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm
C-M079-2-801
ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID
C-M071-6-700
ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD
C-M071-8- Open, Classified |
KWL | None listed |
| Sep 16, 2026 | Howmedica Osteonics Corp. ACETABULAR CUP UHMWPE
61-3258
ALL POLY CONSTRAINED INSERT 44MM
69-2244
ALL POLY CONSTRAINED INSERT 46MM
69-2246
ALL POLY CONSTRAINED INSERT 48MM
69-2248
ALL POLY CONSTRAINED INSERT 50M Open, Classified |
KWZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.