Cleared Traditional

P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM (K954481) - FDA 510(k) Clearance

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

K954481 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Oct 1996
Decision
379d
Days
Class 2
Risk

K954481 is an FDA 510(k) clearance for the P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raritan, US). The FDA issued a Cleared decision on October 10, 1996 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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. Elevated predicate reliance profile. 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K954481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1995
Decision Date October 10, 1996
Days to Decision 379 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
257d slower than avg
Panel avg: 122d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 50
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K954481.
REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
K980665 · Biomet, Inc. · May 1998
OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS
K974434 · Osteonics Corp. · Jan 1998
REPICCI II UNICONDYLAR KNEE
K971938 · Biomet, Inc. · Aug 1997
TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM
K961900 · Wrightmedicaltechnologyinc · Jul 1996
ADVANCE TIBIAL COMPONENT
K960617 · Wrightmedicaltechnologyinc · May 1996
GAS PLASMA STERILIZATION
K944538 · Depuy, Inc. · Sep 1995