Cleared Traditional

SYNATOMIC REVISION FEMORAL PROSTHESIS (K860594) - FDA 510(k) Clearance

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

K860594 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
23d
Days
Class 2
Risk

K860594 is an FDA 510(k) clearance for the SYNATOMIC REVISION FEMORAL PROSTHESIS. 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 14, 1986 after a review of 23 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 K860594 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 19, 1986
Decision Date March 14, 1986
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
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 K860594.
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
M.C.R. KNEE PROSTHESIS (SERIES 3000)
K860654 · Osteonics Corp. · Mar 1986
MILLAR/GALANTE PRECOATED TOTAL KNEE
K853661 · Zimmer, Inc. · Dec 1985
THE P.C.A. DOME PATELLA COMPONENT
K852059 · Howmedica Corp. · Jul 1985