Cleared Traditional

K963255 - PROFIX PLUS TIBIAL INSERT

K963255 is an FDA 510(k) clearance for PROFIX PLUS TIBIAL INSERT, manufactured by Smith & Nephew, Inc., Orthopaedic Div.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K963255 · Smith & Nephew, Inc., Orthopaedic Div. · Orthopedic device
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Jan 1997
Decision
136d
Days
Class 2
Risk

K963255 is an FDA 510(k) clearance for the PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL IN.... Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc., Orthopaedic Div. (Memphis, US). The FDA issued a Cleared decision on January 2, 1997 after a review of 136 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 Smith & Nephew, Inc., Orthopaedic Div. devices

FDA 510(k) Submission Details - K963255

510(k) Number K963255 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 19, 1996
Decision Date January 02, 1997
Days to Decision 136 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 122d · This submission: 136d
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 814
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K963255.
KIRSCHNER KNEE MODIFIED
K961021 · Biomet, Inc. · Mar 1997
KINEMAX PLUS TIBIAL SPACERS
K964951 · Howmedica Corp. · Feb 1997
NEXGEN COMPLETE KNEE SOLUTION
K963148 · Zimmer, Inc. · Feb 1997
FOUNDATION KNEE SYSTEM
K964008 · Encore Orthopedics, Inc. · Dec 1996
KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS
K963796 · Howmedica Corp. · Dec 1996
GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
K962557 · Smith & Nephew Richards, Inc. · Dec 1996