Cleared Traditional

PRO-TOE Hammertoe Fixation System (K151838) - FDA 510(k) Clearance

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

K151838 · Wrightmedicaltechnologyinc · Orthopedic device
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Sep 2015
Decision
60d
Days
Class 2
Risk

K151838 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 (Memphis, US). The FDA issued a Cleared decision on September 4, 2015 after a review of 60 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 K151838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2015
Decision Date September 04, 2015
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 122d · This submission: 60d
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 K151838.
MICATM Screw System
K162353 · Wrightmedicaltechnologyinc · Apr 2017
Biomet Variable Pitch Compression Screw System
K160058 · Biomet, Inc. · Mar 2016
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
K152841 · Zimmer, Inc. · Nov 2015
Arthrex RetroFusion Screw
K151078 · Arthrex, Inc. · May 2015
Subtalar Spacer System (STS)
K150213 · Wrightmedicaltechnologyinc · May 2015
PHALINX Hammertoe System
K150252 · Wrightmedicaltechnologyinc · Apr 2015