Cleared Traditional

DEPUY AMK 3 PEG PATELLA (K972643) - FDA 510(k) Clearance

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

K972643 · Depuy, Inc. · Orthopedic device
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Jan 1998
Decision
190d
Days
Class 2
Risk

K972643 is an FDA 510(k) clearance for the DEPUY AMK 3 PEG PATELLA. 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 January 21, 1998 after a review of 190 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Depuy, Inc. devices

Submission Details

510(k) Number K972643 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 15, 1997
Decision Date January 21, 1998
Days to Decision 190 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
68d slower than avg
Panel avg: 122d · This submission: 190d
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 K972643.
FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM
K980713 · Howmedica Corp. · May 1998
OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM
K974556 · Osteonics Corp. · Feb 1998
ADVANCE TOTAL KNEE SYSTEM
K974328 · Wrightmedicaltechnologyinc · Jan 1998
OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT
K972967 · Osteonics Corp. · Jan 1998
ADVANCE MODULAR TIBIAL COMPONENT
K973524 · Wrightmedicaltechnologyinc · Dec 1997
OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT
K973406 · Osteonics Corp. · Dec 1997