Cleared Traditional

K873197 - AMK TOTAL KNEE SYSTEM

K873197 is an FDA 510(k) clearance for AMK TOTAL KNEE SYSTEM, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K873197 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
71d
Days
Class 2
Risk

K873197 is an FDA 510(k) clearance for the AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT. 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 October 23, 1987 after a review of 71 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

FDA 510(k) Submission Details - K873197

510(k) Number K873197 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 13, 1987
Decision Date October 23, 1987
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K873197.
INTERMEDICS' NATURAL-KNEE(R) REVISION SYSTEM
K873602 · Intermedics Orthopedics · Jan 1988
KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED
K874547 · Kirschner Medical Corp. · Dec 1987
INSALL/BURSTEIN* II MODULAR TOTAL KNEE
K872379 · Zimmer, Inc. · Oct 1987
PLUS TOTAL KNEE SYSTEM, POLY PATELLAR BUTTON
K872134 · Orthomet, Inc. · Oct 1987
HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT
K871349 · Howmedica Corp. · Sep 1987
CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE
K872266 · Dow Corning Wright · Aug 1987