Clearance Summary
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 received FDA 510(k) clearance under submission number K261624, sponsored by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-07-10.
- Submission: K261624
- Applicant / Sponsor: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2026-07-10
Classification & Regulation
This clearance is catalogued under FDA product code LPH and 21 CFR 888.3358, within the Orthopedic review panel as a Class II device.