Cleared Traditional

K982585 - DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORD...

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
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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 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K982585.
NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS
K983153 · Sulzer Orthopedics, Inc. · Dec 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