Cleared Traditional

K854943 - OMKNEE SYSTEM, POROUS COATED (FDA 510(k) Clearance)

K854943 · Orthomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
72d
Days
-
Risk

K854943 is an FDA 510(k) clearance for the OMKNEE SYSTEM, POROUS COATED.

Submitted by Orthomet, Inc. (Plymouth, US). The FDA issued a Cleared decision on February 20, 1986 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. 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 Orthomet, Inc. devices

Submission Details

510(k) Number K854943 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 10, 1985
Decision Date February 20, 1986
Days to Decision 72 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -