Cleared Traditional

K863668 - OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM

K863668 is an FDA 510(k) clearance for OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM, manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K863668 · Osteonics Corp. · Orthopedic device
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Dec 1986
Decision
92d
Days
Class 2
Risk

K863668 is an FDA 510(k) clearance for the OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on December 19, 1986 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteonics Corp. devices

FDA 510(k) Submission Details - K863668

510(k) Number K863668 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 18, 1986
Decision Date December 19, 1986
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 893
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K863668.
LACEY PRESS-FIT CONDYLAR TOTAL KNEE
K864518 · Dow Corning Wright · Mar 1987
ANATOMIC MODULAR KNEE (AMK) SYSTEM
K864671 · Depuy, Inc. · Feb 1987
WHITESIDE ORTHOLOC II METAL BACKED PATELLA
K864627 · Dow Corning Wright · Feb 1987
MODIFIED SYNATOMIC KNEE PATELLA PROSTHESIS
K863667 · Depuy, Inc. · Dec 1986
MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME
K863805 · Zimmer, Inc. · Dec 1986
HOWMEDICA KINEMATIC PLUS KNEE SYSTEM
K861266 · Howmedica Corp. · Jul 1986