Cleared Traditional

K864632 - P.C.A. MODULAR KNEE SYSTEM

K864632 is the FDA 510(k) clearance for P.C.A. MODULAR KNEE SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K864632 · Howmedica Corp. · Orthopedic device
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Mar 1987
Decision
101d
Days
Class 2
Risk

K864632 is an FDA 510(k) clearance for the P.C.A. MODULAR KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on March 6, 1987 after a review of 101 days - within the typical 510(k) review window.

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 Howmedica Corp. devices

Submission Details

510(k) Number K864632 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 25, 1986
Decision Date March 06, 1987
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
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 768
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K864632.
KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY
K871772 · Howmedica Corp. · Jun 1987
OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION)
K871769 · Osteonics Corp. · Jun 1987
ADG PATELLAR COMPONENT
K870702 · Buckman Co., Inc. · Apr 1987
LACEY PRESS-FIT CONDYLAR TOTAL KNEE
K864518 · Dow Corning Wright · Mar 1987
ANATOMIC MODULAR KNEE (AMK) SYSTEM
K864671 · Depuy, Inc. · Feb 1987
WHITESIDE ORTHOLOC II METAL BACKED PATELLA
K864627 · Dow Corning Wright · Feb 1987