Cleared Traditional

K261624 - Omnifit 20° Series I Insert

Also marketed or referenced as:
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

K261624 is the FDA 510(k) clearance for Omnifit 20° Series I Insert by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K261624 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
56d
Days
Class 2
Risk

K261624 is an FDA 510(k) clearance for the Omnifit® 20° Series I Insert. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on July 10, 2026 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica Osteonics Corp., Dba Stryker Orthopaedics devices

Submission Details

510(k) Number K261624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2026
Decision Date July 10, 2026
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 425
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