Cleared Traditional

AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT (K873197) - FDA 510(k) Clearance

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

K873197 · Depuy, Inc. · Orthopedic device
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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

Submission Details

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.

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 K873197.
PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP
K881982 · Howmedica Corp. · Jul 1988
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
K874635 · Osteonics Corp. · Mar 1988
INSALL/BURSTEIN* II MODULAR TOTAL KNEE
K872379 · Zimmer, Inc. · Oct 1987
HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT
K871349 · Howmedica Corp. · Sep 1987
MODIFIED ANATOMIC MODULAR KNEE (AMK) SYSTEM
K871585 · Depuy, Inc. · Jul 1987
KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY
K871772 · Howmedica Corp. · Jun 1987