Cleared Traditional

K854883 - OMKNEE SYSTEM

K854883 is an FDA 510(k) clearance for OMKNEE SYSTEM, manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K854883 · Orthomet, Inc. · Orthopedic device
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Feb 1986
Decision
74d
Days
Class 2
Risk

K854883 is an FDA 510(k) clearance for the OMKNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Orthomet, Inc. (Plymouth, US). The FDA issued a Cleared decision on February 18, 1986 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Orthomet, Inc. devices

FDA 510(k) Submission Details - K854883

510(k) Number K854883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1985
Decision Date February 18, 1986
Days to Decision 74 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K854883.
SYNATOMIC REVISION FEMORAL PROSTHESIS
K860594 · Depuy, Inc. · Mar 1986
M.C.R. KNEE PROSTHESIS (SERIES 3000)
K860654 · Osteonics Corp. · Mar 1986
HOFMANN KNEE
K853991 · Intermedics Orthopedics · Feb 1986
MILLAR/GALANTE PRECOATED TOTAL KNEE
K853661 · Zimmer, Inc. · Dec 1985
THE P.C.A. DOME PATELLA COMPONENT
K852059 · Howmedica Corp. · Jul 1985
RMC POSTERIOR STABILIZED KNEE SYSTEM
K851231 · Richards Medical Co., Inc. · May 1985