Cleared Traditional

K072922 - 3S HEMI TOE

K072922 is an FDA 510(k) clearance for 3S HEMI TOE, manufactured by Trilliant Surgical, Ltd.. The device is a Class 2 Orthopedic device with product code KWD cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K072922 · Trilliant Surgical, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
44d
Days
Class 2
Risk

K072922 is an FDA 510(k) clearance for the 3S HEMI TOE. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Trilliant Surgical, Ltd. (Round Rock, US). The FDA issued a Cleared decision on November 28, 2007 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3730 - 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 - K072922

510(k) Number K072922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2007
Decision Date November 28, 2007
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.

KWD Device Classification - Class 2, Special Controls

Product Code KWD Prosthesis, Toe, Hemi-, Phalangeal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3730
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 - KWD Prosthesis, Toe, Hemi-, Phalangeal

All 28
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K072922.
OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING
K081876 · Osteomed LP · Aug 2008
SBI SR MTP TOE IMPLANT
K073635 · Small Bone Innovations, Inc. · Mar 2008
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM
K073065 · Osteomed LP · Feb 2008
CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY
K063370 · Arthrosurface, Inc. · Jan 2007
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
K063058 · Arthrex, Inc. · Jan 2007
SBI TRIHEDRON MTP HEMI GT
K062040 · Small Bone Innovations, Inc. · Oct 2006