Cleared Traditional

K931214 - P.C.A. MODULAR KNEE SYSTEM

K931214 is an FDA 510(k) clearance for P.C.A. MODULAR KNEE SYSTEM, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K931214 · Howmedica Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 1994
Decision
342d
Days
Class 2
Risk

K931214 is an FDA 510(k) clearance for the P.C.A. MODULAR KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on February 15, 1994 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K931214

510(k) Number K931214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1993
Decision Date February 15, 1994
Days to Decision 342 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
220d slower than avg
Panel avg: 122d · This submission: 342d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSX Device Classification - Class 2, Special Controls

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 109
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K931214.
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM
K942263 · Zimmer, Inc. · Jul 1995
DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT
K945613 · Howmedica Corp. · Mar 1995
PRESERVATION UNICOMPARTMENTAL KNEE
K941606 · Depuy, Inc. · Oct 1994
DURACON UNICOMPARTMENTAL KNEE SYSTEM
K926231 · Howmedica Corp. · Mar 1993
KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM
K922824 · Joint Medical Products Corp. · Sep 1992
KEANE UNI KNEE SYSTEM WITH POROCOAT
K921232 · Depuy, Inc. · Jun 1992