Cleared Traditional

K864632 - P.C.A. MODULAR KNEE SYSTEM

K864632 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 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

FDA 510(k) Submission Details - K864632

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.

JWH Device Classification - Class 2, Special Controls

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 885
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K864632.
OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION)
K871769 · Osteonics Corp. · Jun 1987
NOILES TOTAL KNEE PROSTHESIS
K870730 · Joint Medical Products Corp. · May 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