Cleared Special

K063479 - ARTHREX PUSHLOCK

K063479 is an FDA 510(k) clearance for ARTHREX PUSHLOCK, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 26-day FDA review.

K063479 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
26d
Days
Class 2
Risk

K063479 is an FDA 510(k) clearance for the ARTHREX PUSHLOCK. 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 December 13, 2006 after a review of 26 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

FDA 510(k) Submission Details - K063479

510(k) Number K063479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2006
Decision Date December 13, 2006
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
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 931
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K063479.
OSTEOMED HEADLESS CANNULATED SCREW SYSTEM
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K063478 · Depuy Mitek, A Johnson & Johnson Company · Dec 2006
APERFIX TIBIAL IMPLANT WITH INSERTER
K063070 · Cayenne Medical, Inc. · Dec 2006
APERFIX FEMORAL IMPLANT WITH INSERTER
K062487 · Cayenne Medical, Inc. · Nov 2006
OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM
K062863 · Osteomed LP · Oct 2006
ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY
K061863 · Arthrex, Inc. · Oct 2006