Cleared Special

K024340 - SMITH & NEPHEW FEMORAL HEADS

K024340 is an FDA 510(k) clearance for SMITH & NEPHEW FEMORAL HEADS, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Special 510(k) pathway after a 61-day FDA review.

K024340 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
61d
Days
Class 2
Risk

K024340 is an FDA 510(k) clearance for the SMITH & NEPHEW FEMORAL HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 26, 2003 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K024340

510(k) Number K024340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2002
Decision Date February 26, 2003
Days to Decision 61 days
Submission Type Special
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
61d faster than avg
Panel avg: 122d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 564
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K024340.
PLUS ORTHOPEDICS CEMENTED HIP STEM
K031165 · Plus Orthopedics · Jun 2003
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
K030153 · Zimmer, Inc. · Apr 2003
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
K030265 · Zimmer, Inc. · Mar 2003
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE
K022799 · Howmedica Osteonics Corp. · Nov 2002
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
K023453 · DePuy Orthopaedics, Inc. · Nov 2002
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
K023646 · Exactech, Inc. · Nov 2002
K024340 · SMITH & NEPHEW FEMORAL HEADS
Download PDF FDA Summary Smith & Nephew, Inc.