Cleared Traditional

P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL (K910563) - FDA 510(k) Clearance

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

K910563 · Johnson & Johnson Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
104d
Days
Class 2
Risk

K910563 is an FDA 510(k) clearance for the P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Johnson & Johnson Orthopaedics, Inc. (Raynham, US). The FDA issued a Cleared decision on May 23, 1991 after a review of 104 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 Johnson & Johnson Orthopaedics, Inc. devices

Submission Details

510(k) Number K910563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1991
Decision Date May 23, 1991
Days to Decision 104 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 122d · This submission: 104d
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 522
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K910563.
PCA MTK II TOTAL KNEE SYSTEM
K910235 · Howmedica Corp. · Jun 1991
OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS
K910990 · Osteonics Corp. · Jun 1991
OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP
K910989 · Osteonics Corp. · Jun 1991
HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM
K910500 · Howmedica Corp. · May 1991
KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM
K904208 · Howmedica Corp. · Apr 1991
AMK MODULAR TIBIAL WEDGE SYSTEM
K904205 · Depuy, Inc. · Oct 1990