Cleared Traditional

K935262 - P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA

K935262 is an FDA 510(k) clearance for P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA, manufactured by Johnson & Johnson Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K935262 · Johnson & Johnson Orthopaedics, Inc. · Orthopedic device
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Jun 1994
Decision
212d
Days
Class 2
Risk

K935262 is an FDA 510(k) clearance for the P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA. 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 June 3, 1994 after a review of 212 days - an extended review cycle.

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

FDA 510(k) Submission Details - K935262

510(k) Number K935262 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 03, 1993
Decision Date June 03, 1994
Days to Decision 212 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
90d slower than avg
Panel avg: 122d · This submission: 212d
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 847
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K935262.
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LACEY ALL POLYETHYLENE TIBIAL COMPONENT
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HOWMEDICAL TOTAL KNEE STEM EXTENDER
K924482 · Howmedica Corp. · Feb 1994
DURACON CRUCIFORM TIBIAL BASEPLATE
K926228 · Howmedica Corp. · Feb 1994
ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT
K932858 · Dow Corning Wright · Feb 1994