Cleared Traditional

K946236 - PROFIX CONFORMING PLUS TIBIAL INSERT

K946236 is the FDA 510(k) clearance for PROFIX CONFORMING PLUS TIBIAL INSERT by Smith & Nephew Richards, Inc.. It is a Class 2 Orthopedic device (product code KWH) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K946236 · Smith & Nephew Richards, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Smith & Nephew Richards, Inc. devices

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - KWH Prosthesis, Toe, Constrained, Polymer

All 9
Devices cleared under the same product code (KWH) and FDA review panel - the closest regulatory comparables to K946236.
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022887 · Osteomed Corp. · Nov 2002
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022886 · Osteomed Corp. · Nov 2002
ASCENT KNEE SYSTEM
K994326 · Biomet Manufacturing, Inc. · Jan 2000
ZIMMER GREAT TOE
K823405 · Zimmer, Inc. · Jan 1983
SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL
K801094 · Dow Corning Corp. Healthcare Industries Materials · Jun 1980
IMPLANT, HINGE TOE, FLEX.
K780132 · Dow Corning Corp. Healthcare Industries Materials · Feb 1978