Cleared Traditional

K982585 - DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM

K982585 is an FDA 510(k) clearance for DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORD..., manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K982585 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
73d
Days
Class 2
Risk

K982585 is an FDA 510(k) clearance for the DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 5, 1998 after a review of 73 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 Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K982585

510(k) Number K982585 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 24, 1998
Decision Date October 05, 1998
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
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 908
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K982585.
CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI
K983004 · Hayes Medical, Inc. · Nov 1998
ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT
K980999 · Instrument Makar, Inc. · Nov 1998
SULZER ORTHOPEDICS FLUTED STEMS
K982903 · Sulzer Orthopedics, Inc. · Oct 1998
ASCENT SYSTEM
K982869 · Biomet, Inc. · Sep 1998
IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS
K982302 · Implex Corp. · Jul 1998
DURACON(R) SMALL STABILIZER TIBIAL INSERT
K974843 · Howmedica Corp. · Jun 1998