Cleared Abbreviated

K061243 - SMITH & NEPHEW MODULAR FEMORAL HEAD (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K061243 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
75d
Days
Class 2
Risk

K061243 is an FDA 510(k) clearance for the SMITH & NEPHEW MODULAR FEMORAL HEAD. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on July 17, 2006 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 K061243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2006
Decision Date July 17, 2006
Days to Decision 75 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 105
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K061243.
OsteoRemedies Hip Spacer System
K253675 · Osteoremedies, LLC · Dec 2025
InterSpace GV Hip Spacer
K252326 · Tecres S.P.A. · Aug 2025
Synicem Hip Spacer
K242865 · Biocomposites, Ltd. · Jun 2025
COPAL® exchange G hip spacer
K234028 · Heraeus Medical GmbH · Feb 2024
UHR Bipolar Implants, Restoration GAP II Implants
K222632 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Oct 2022