Cleared Special

K050849 - HA COATED LAG SCREW

K050849 is an FDA 510(k) clearance for HA COATED LAG SCREW, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 30-day FDA review.

K050849 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
30d
Days
Class 2
Risk

K050849 is an FDA 510(k) clearance for the HA COATED LAG SCREW. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on May 4, 2005 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K050849

510(k) Number K050849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2005
Decision Date May 04, 2005
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 404
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K050849.
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR
K051049 · Synthes (Usa) · Jul 2005
R-X-FIX EXTERNAL FIXATOR
K051017 · R-X-Fix · Jun 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K051554 · Alliance Medical Corp. · Jun 2005
MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM
K050457 · Merete Medical GmbH · Mar 2005
HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM
K050048 · Howmedica Osteonics Corp. · Mar 2005
E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT
K043289 · Signal Medical Corp. · Feb 2005
K050849 · HA COATED LAG SCREW
Download PDF FDA Summary Smith & Nephew, Inc.