Cleared Traditional

K061863 - ARTHREX CORKSCREW SUTURE ANCHOR

K061863 is the FDA 510(k) clearance for ARTHREX CORKSCREW SUTURE ANCHOR by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K061863 · Arthrex, Inc. · Orthopedic device
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Oct 2006
Decision
111d
Days
Class 2
Risk

K061863 is an FDA 510(k) clearance for the ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY. 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 October 19, 2006 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K061863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2006
Decision Date October 19, 2006
Days to Decision 111 days
Submission Type Traditional
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
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K061863.
CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER
K070525 · Wrightmedicaltechnologyinc · Mar 2007
VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810)
K063478 · Depuy Mitek, A Johnson & Johnson Company · Dec 2006
ARTHREX PUSHLOCK
K063479 · Arthrex, Inc. · Dec 2006
FRS SCREW
K062352 · DePuy Orthopaedics, Inc. · Oct 2006
ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES
K062679 · Arthrex, Inc. · Sep 2006
SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS
K061621 · Synthes (Usa) · Jul 2006