Cleared Special

ARTHERX CORKSCREW FT II SUTURE ANCHOR (K050358) - FDA 510(k) Clearance

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

K050358 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
60d
Days
Class 2
Risk

K050358 is an FDA 510(k) clearance for the ARTHERX CORKSCREW FT II SUTURE ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on April 15, 2005 after a review of 60 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 Arthrex, Inc. devices

Submission Details

510(k) Number K050358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2005
Decision Date April 15, 2005
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 400
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K050358.
ARTHREX TAK FAMILY
K050749 · Arthrex, Inc. · May 2005
SYNTHES (USA) 3.5MM CONICAL SCREWS
K050683 · Synthes (Usa) · Apr 2005
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
K050636 · Synthes (Usa) · Apr 2005
CHARLOTTE SNAP-OFF SCREW
K050819 · Wrightmedicaltechnologyinc · Apr 2005
MODIFICATION TO: ARTHREX V-TAK
K050634 · Arthrex, Inc. · Mar 2005
ASIAN INTRAMEDULLARY HIP SCREW NAILS
K050226 · Smith & Nephew, Inc. · Feb 2005