Cleared Traditional

K142478 - opti-Toe

K142478 is an FDA 510(k) clearance for opti-Toe, manufactured by Graham Medical Technologies, LLC (D.B.A.Gramedica). The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K142478 · Graham Medical Technologies, LLC (D.B.A.Gramedica) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
268d
Days
Class 2
Risk

K142478 is an FDA 510(k) clearance for the opti-Toe. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Graham Medical Technologies, LLC (D.B.A.Gramedica) (Macomb, US). The FDA issued a Cleared decision on May 29, 2015 after a review of 268 days - an extended review cycle.

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 Graham Medical Technologies, LLC (D.B.A.Gramedica) devices

FDA 510(k) Submission Details - K142478

510(k) Number K142478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2014
Decision Date May 29, 2015
Days to Decision 268 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
146d slower than avg
Panel avg: 122d · This submission: 268d
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
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