Cleared Traditional

PRO-TOE HAMMERTOE FIXATION SYSTEM (K140148) - FDA 510(k) Clearance

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

K140148 · Wrightmedicaltechnologyinc · Orthopedic device
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Mar 2014
Decision
44d
Days
Class 2
Risk

K140148 is an FDA 510(k) clearance for the PRO-TOE HAMMERTOE FIXATION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on March 7, 2014 after a review of 44 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. 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K140148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2014
Decision Date March 07, 2014
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 400
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K140148.
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
K140952 · Wrightmedicaltechnologyinc · May 2014
SALVATION OSTEOPENIC SCREW
K140408 · Wrightmedicaltechnologyinc · May 2014
CHARLOTTE (TM) SNAP-OFF SCREW
K133713 · Wrightmedicaltechnologyinc · Mar 2014
ARTHREX COMPRESSION FT SCREWS
K132217 · Arthrex, Inc. · Nov 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · Zimmer, Inc. · Sep 2013
MEDLINE CANNULATED SCREW
K130319 · Medline Industries, Inc. · May 2013