Cleared Abbreviated

K151902 - REDAPT¿ Revision Femoral System

K151902 is the FDA 510(k) clearance for REDAPT¿ Revision Femoral System by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Abbreviated 510(k) pathway after a 55-day FDA review.

K151902 · Smith & Nephew, Inc. · Orthopedic device
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Sep 2015
Decision
55d
Days
Class 2
Risk

K151902 is an FDA 510(k) clearance for the REDAPT¿ Revision Femoral System. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on September 3, 2015 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K151902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2015
Decision Date September 03, 2015
Days to Decision 55 days
Submission Type Abbreviated
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
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 421
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K151902.
UCP Stem
K152530 · United Orthopedic Corporation · Mar 2016
Revision Femoral Stem
K151739 · Lima Corporate S.P.A. · Nov 2015
MasterLoc Stem
K151531 · Medacta International · Oct 2015
Exactech Alteon Monobloc Revision Stem
K150066 · Exactech, Inc. · Jul 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
K143739 · Smith & Nephew, Inc. · Apr 2015
PROFEMUR Preserve Size 1-3 Hip Stems
K150133 · Microport Orthopedics, Inc. · Apr 2015