Cleared Traditional

K955884 - COORDINATE REVISION KNEE SYSTEM

K955884 is the FDA 510(k) clearance for COORDINATE REVISION KNEE SYSTEM by Depuy, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K955884 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
76d
Days
Class 2
Risk

K955884 is an FDA 510(k) clearance for the COORDINATE REVISION KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 13, 1996 after a review of 76 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 Depuy, Inc. devices

Submission Details

510(k) Number K955884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1995
Decision Date March 13, 1996
Days to Decision 76 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 122d · This submission: 76d
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 786
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K955884.
APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA
K960535 · Intermedics Orthopedics · Apr 1996
NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE
K951185 · Zimmer, Inc. · Mar 1996
FREEMAN/SAMUELSON TOTAL KNEE SYSTEM
K943025 · Biomet, Inc. · Mar 1996
OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY
K954208 · Exactech, Inc. · Feb 1996
OSTEONICS N2/VAC PACKAGING PROCESS
K955421 · Osteonics Corp. · Feb 1996
GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM
K953274 · Smith & Nephew Richards, Inc. · Feb 1996