Cleared Traditional

K133477 - TOEGRIP

K133477 is an FDA 510(k) clearance for TOEGRIP, manufactured by Synchro Medical. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K133477 · Synchro Medical · Orthopedic device
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Feb 2014
Decision
90d
Days
Class 2
Risk

K133477 is an FDA 510(k) clearance for the TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Synchro Medical (West Lawn, US). The FDA issued a Cleared decision on February 10, 2014 after a review of 90 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 Synchro Medical devices

FDA 510(k) Submission Details - K133477

510(k) Number K133477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2013
Decision Date February 10, 2014
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 114
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K133477.
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
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RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM
K130105 · Depuy Mitek, A Johnson & Johnson Company · May 2013
INTRAOSSEOUS FIXATION SYSTEM
K120165 · Orthohelix Surgical Designs, Inc. · Apr 2012