Cleared Abbreviated

K053246 - PATIENT MATCHED HIP STEM

K053246 is the FDA 510(k) clearance for PATIENT MATCHED HIP STEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Abbreviated 510(k) pathway after a 233-day FDA review.

K053246 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
233d
Days
Class 2
Risk

K053246 is an FDA 510(k) clearance for the PATIENT MATCHED HIP STEM. 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. (Memphis, US). The FDA issued a Cleared decision on July 12, 2006 after a review of 233 days - an extended review 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 K053246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2005
Decision Date July 12, 2006
Days to Decision 233 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
111d slower than avg
Panel avg: 122d · This submission: 233d
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 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K053246.
NOVATION SPLINED RDD FEMORAL STEMS
K063279 · Exactech, Inc. · Nov 2006
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
K062684 · Aesculap, Inc. · Nov 2006
SYNERGY HIP SYSTEM
K061066 · Smith & Nephew, Inc. · Jul 2006
36MM BIOLOX DELTA CERAMIC HEADS
K061312 · Biomet, Inc. · Jun 2006
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
K060918 · Aesculap, Inc. · May 2006
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
K060577 · Ortho Development Corp. · Apr 2006