Cleared Traditional

K130859 - HAMMERTOE CORRECTION SYSTEM

K130859 is an FDA 510(k) clearance for HAMMERTOE CORRECTION SYSTEM, manufactured by Arthrosurface, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K130859 · Arthrosurface, Inc. · Orthopedic device
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Jul 2013
Decision
119d
Days
Class 2
Risk

K130859 is an FDA 510(k) clearance for the HAMMERTOE CORRECTION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on July 25, 2013 after a review of 119 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 Arthrosurface, Inc. devices

FDA 510(k) Submission Details - K130859

510(k) Number K130859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2013
Decision Date July 25, 2013
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K130859.
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
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ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
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MEDLINE CANNULATED SCREW
K130319 · Medline Industries, Inc. · May 2013
MAXTORQUE SCREW SYSTEM
K131324 · Orthohelix Surgical Designs, Inc. · May 2013
AAP CANNULATED SCREW 2.0
K130590 · Aap Implantate AG · Apr 2013