Cleared Traditional

K946236 - PROFIX CONFORMING PLUS TIBIAL INSERT (FDA 510(k) Clearance)

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

K946236 · Smith & Nephew Richards, Inc. · Orthopedic device
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Jul 1995
Decision
196d
Days
Class 2
Risk

K946236 is an FDA 510(k) clearance for the PROFIX CONFORMING PLUS TIBIAL INSERT. Classified as Prosthesis, Toe, Constrained, Polymer (product code KWH), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on July 6, 1995 after a review of 196 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3720 - 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.

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Submission Details

510(k) Number K946236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1994
Decision Date July 06, 1995
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 122d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWH Prosthesis, Toe, Constrained, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3720
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.