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
FDA 510(k) clearance K261624 · decided 2026-07-10
Clearance details
- K-number
- K261624
- Device name
- 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
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decision
- Substantially Equivalent
- Date received
- 2026-05-15
- Decision date
- 2026-07-10
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Howmedica Osteonics Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TRIVANCE™ Hip Stem (K254043) | Globus Medical, Inc. | 2026-08-04 |
| iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating (K243192) | Nextstep Arthopedix, LLC | 2026-06-05 |
| Taperloc® Complete Hip Stem (K251270) | Biomet, Inc. | 2026-05-19 |
| G7® Revision Acetabular System (K252623) | Zimmer, Inc. | 2026-02-04 |
| Mpact 3D Metal Implants Extension – DMLS Technology (K251043) | Medacta International S.A. | 2026-01-28 |
| Velora Acetabular System (K252067) | Restor3D, Inc. | 2025-12-05 |
| TaperSet™ Hip System (K252846) | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2025-11-20 |
| EMPOWR Acetabular® Liner Extension (K251833) | Encore Medical L.P. | 2025-11-12 |
| ArTT Augments and Buttresses and Bone Screws (K251718) | Lima Corporate S.P.A. | 2025-08-29 |
| Stryker and Serf hip devices (K250989) | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025-07-25 |
| ONVOY™ Acetabular System (K243456) | Globus Medical, Inc. | 2025-06-06 |
| Trinity EVO Acetabular Shell (K242744) | Corin U.S.A. Limited | 2025-06-05 |
Recalls involving this device
No recalls on record reference this clearance.