Cleared Traditional

K113762 - CHECKMATE METATARSO-PHALANGEAL (MTP) AR...

K113762 is an FDA 510(k) clearance for CHECKMATE METATARSO-PHALANGEAL (MTP) AR..., manufactured by Arthrosurface, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K113762 · Arthrosurface, Inc. · Orthopedic device
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Feb 2012
Decision
47d
Days
Class 2
Risk

K113762 is an FDA 510(k) clearance for the CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on February 6, 2012 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrosurface, Inc. devices

FDA 510(k) Submission Details - K113762

510(k) Number K113762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2011
Decision Date February 06, 2012
Days to Decision 47 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
75d faster than avg
Panel avg: 122d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K113762.
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K113014 · Wrightmedicaltechnologyinc · Jan 2012
MAXLOCK EXTREME SYSTEM
K113048 · Orthohelix Surgical Designs, Inc. · Jan 2012
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K113718 · Zimmer GmbH · Jan 2012