Cleared Traditional

K122959 - HAMMER TOE IMPLANT

K122959 is an FDA 510(k) clearance for HAMMER TOE IMPLANT, manufactured by Trilliant Surgical, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K122959 · Trilliant Surgical, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
43d
Days
Class 2
Risk

K122959 is an FDA 510(k) clearance for the HAMMER TOE IMPLANT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Trilliant Surgical, Ltd. (Round Rock, US). The FDA issued a Cleared decision on November 7, 2012 after a review of 43 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 Trilliant Surgical, Ltd. devices

FDA 510(k) Submission Details - K122959

510(k) Number K122959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2012
Decision Date November 07, 2012
Days to Decision 43 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
79d faster than avg
Panel avg: 122d · This submission: 43d
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 726
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K122959.
ACUMED CANNULATED SCREW SYSTEM
K123890 · Acumed, LLC · Mar 2013
MILAGRO ADVANCE INTERFERENCE SCREW
K123362 · Depuy Mitek, A Johnson & Johnson Company · Feb 2013
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · Smith & Nephew, Inc. · Nov 2012
PMT BONE SCREWS
K121713 · Providence Medical Technology, Inc. · Sep 2012
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
K121349 · Extremity Medical, LLC · Jul 2012
XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
K121417 · Extremity Medical, LLC · Jul 2012