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)
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.

View all Smith & Nephew, Inc. devices

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 927
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