Cleared Special

K170350 - ToeMATE Hammertoe Correction System

K170350 is an FDA 510(k) clearance for ToeMATE Hammertoe Correction System, manufactured by Arthrosurface, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 28-day FDA review.

K170350 · Arthrosurface, Inc. · Orthopedic device
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Mar 2017
Decision
28d
Days
Class 2
Risk

K170350 is an FDA 510(k) clearance for the ToeMATE® 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 March 3, 2017 after a review of 28 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 Arthrosurface, Inc. devices

FDA 510(k) Submission Details - K170350

510(k) Number K170350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2017
Decision Date March 03, 2017
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 690
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170350.
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