Cleared Special

K050226 - ASIAN INTRAMEDULLARY HIP SCREW NAILS

K050226 is an FDA 510(k) clearance for ASIAN INTRAMEDULLARY HIP SCREW NAILS, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 10-day FDA review.

K050226 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
10d
Days
Class 2
Risk

K050226 is an FDA 510(k) clearance for the ASIAN INTRAMEDULLARY HIP SCREW NAILS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 11, 2005 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 - K050226

510(k) Number K050226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2005
Decision Date February 11, 2005
Days to Decision 10 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
112d faster than avg
Panel avg: 122d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K050226.
STABILIZATION SCREW
K050346 · New Deal, S.A. · Mar 2005
EPIPHYSIS SCREW
K043410 · I.T.S. Implantat-Technologie-Systeme GmbH · Feb 2005
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K043142 · Inion , Ltd. · Feb 2005
SYNTHES 3.5MM CORTEX SCREWS
K043185 · Synthes (Usa) · Feb 2005
CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
K043583 · Wrightmedicaltechnologyinc · Jan 2005
MULTI-USE COMPRESSION SCREW
K043102 · Wrightmedicaltechnologyinc · Jan 2005
K050226 · ASIAN INTRAMEDULLARY HIP SCREW NAILS
Download PDF FDA Summary Smith & Nephew, Inc.