Cleared Traditional

CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM (K113762) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K113762.
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS
K120802 · Wrightmedicaltechnologyinc · Apr 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
K120070 · Synthes (Usa) · Mar 2012
TRAUMA INTERNAL FIXATION SYSTEMS
K111663 · DePuy Orthopaedics, Inc. · Mar 2012
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
K113014 · Wrightmedicaltechnologyinc · Jan 2012
ORTHOLOC 3DSI LOCKING SCREWS
K113339 · Wrightmedicaltechnologyinc · Dec 2011
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
K112406 · Smith & Nephew, Inc. · Nov 2011