Cleared Traditional

KEANE UNI KNEE SYSTEM WITH POROCOAT (K921232) - FDA 510(k) Clearance

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

K921232 · Depuy, Inc. · Orthopedic device
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Jun 1992
Decision
88d
Days
Class 2
Risk

K921232 is an FDA 510(k) clearance for the KEANE UNI KNEE SYSTEM WITH POROCOAT. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 9, 1992 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 K921232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1992
Decision Date June 09, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 69
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K921232.
PRESERVATION UNICOMPARTMENTAL KNEE
K941606 · Depuy, Inc. · Oct 1994
P.C.A. MODULAR KNEE SYSTEM
K931214 · Howmedica Corp. · Feb 1994
DURACON UNICOMPARTMENTAL KNEE SYSTEM
K926231 · Howmedica Corp. · Mar 1993
KEANE UNI KNEE SYSTEM
K910807 · Depuy, Inc. · Jun 1991
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
K910083 · Osteonics Corp. · Apr 1991
MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS
K896856 · Osteonics Corp. · Feb 1990