Cleared Traditional

K132217 - ARTHREX COMPRESSION FT SCREWS

K132217 is an FDA 510(k) clearance for ARTHREX COMPRESSION FT SCREWS, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K132217 · Arthrex, Inc. · Orthopedic device
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Nov 2013
Decision
131d
Days
Class 2
Risk

K132217 is an FDA 510(k) clearance for the ARTHREX COMPRESSION FT SCREWS. 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 November 25, 2013 after a review of 131 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

FDA 510(k) Submission Details - K132217

510(k) Number K132217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2013
Decision Date November 25, 2013
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 943
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K132217.
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
K132910 · Synthes USA Products, LLC · Dec 2013
NORMED PELLEGRIN CALCANEUS STOP SCREW
K133035 · Normed Medizin-Technik GmbH · Dec 2013
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
K131591 · Pega Medical, Inc. · Nov 2013
EDGE ORTHOPAEDICS BITE COMPRESSION SCREW
K132893 · Icon Orthopaedic Concepts Dba Edge Orthopaedics · Nov 2013
FLOWER BONE SCREW SET
K132248 · Flower Orthopedics Corporation · Oct 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · Zimmer, Inc. · Sep 2013