Cleared Traditional

OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM (K863668) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K863668.
OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION)
K871769 · Osteonics Corp. · Jun 1987
P.C.A. MODULAR KNEE SYSTEM
K864632 · Howmedica Corp. · Mar 1987
ANATOMIC MODULAR KNEE (AMK) SYSTEM
K864671 · Depuy, Inc. · 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