Cleared Special

CHARLOTTE SNAP-OFF SCREW (K050819) - FDA 510(k) Clearance

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

K050819 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
11d
Days
Class 2
Risk

K050819 is an FDA 510(k) clearance for the CHARLOTTE SNAP-OFF SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on April 11, 2005 after a review of 11 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K050819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2005
Decision Date April 11, 2005
Days to Decision 11 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
111d faster than avg
Panel avg: 122d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 403
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K050819.
SYNTHES (USA) 3.5MM CONICAL SCREWS
K050683 · Synthes (Usa) · Apr 2005
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
K050636 · Synthes (Usa) · Apr 2005
ARTHERX CORKSCREW FT II SUTURE ANCHOR
K050358 · Arthrex, Inc. · Apr 2005
MODIFICATION TO: ARTHREX V-TAK
K050634 · Arthrex, Inc. · Mar 2005
ASIAN INTRAMEDULLARY HIP SCREW NAILS
K050226 · Smith & Nephew, Inc. · Feb 2005
SYNTHES 3.5MM CORTEX SCREWS
K043185 · Synthes (Usa) · Feb 2005