Cleared Traditional

K140148 - PRO-TOE HAMMERTOE FIXATION SYSTEM

K140148 is an FDA 510(k) clearance for PRO-TOE HAMMERTOE FIXATION SYSTEM, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K140148 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K140148

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.

HWC Device Classification - Class 2, Special Controls

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 949
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K140148.
EXTREMITY MEDICAL HAMMERTOE DEVICE
K133636 · Extremity Medical, LLC · Mar 2014
TYBER MEDICAL TRAUMA SCREW
K133842 · Tyber Medical, LLC · Mar 2014
CHARLOTTE (TM) SNAP-OFF SCREW
K133713 · Wrightmedicaltechnologyinc · Mar 2014
N-FORCE FIXATION SYSTEM
K132244 · Innovision, Inc. · Mar 2014
FIXOS SCREW SYSTEM
K133451 · Stryker Trauma AG · Feb 2014
OSTEOMED EXTREMIFUSE SYSTEM
K140283 · Osteomed · Feb 2014