Cleared Traditional

TI-FIT FEMORAL COMPONENT (K914343) - FDA 510(k) Clearance

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

K914343 · Smith & Nephew Richards, Inc. · Orthopedic device
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Jan 1992
Decision
108d
Days
Class 2
Risk

K914343 is an FDA 510(k) clearance for the TI-FIT FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on January 13, 1992 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 K914343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1991
Decision Date January 13, 1992
Days to Decision 108 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
14d faster than avg
Panel avg: 122d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 25
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K914343.
HOWMEDICA V40 22MM FEMORAL HEAD
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COBALT CHROME GEMINI
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OSTEONICS 22MM, +10 NECK BEARING HEADS
K933359 · Osteonics Corp. · Mar 1994
HOWMEDICA HNR SYSTEM
K903563 · Howmedica Corp. · Mar 1991
THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH
K905254 · Depuy, Inc. · Feb 1991
ACSYS SELFTAP ACETABULAR CUP PROSTHESIS
K900262 · 3M Company · Sep 1990