Cleared Traditional

K102401 - HEMI IMPLANT

Also marketed or referenced as:
MINI HEMI IMPLANT

K102401 is an FDA 510(k) clearance for HEMI IMPLANT, manufactured by Vilex, Inc.. The device is a Class 2 Orthopedic device with product code KWD cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K102401 · Vilex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
330d
Days
Class 2
Risk

K102401 is an FDA 510(k) clearance for the HEMI IMPLANT. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Vilex, Inc. (Mcminnville, US). The FDA issued a Cleared decision on July 20, 2011 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Vilex, Inc. devices

FDA 510(k) Submission Details - K102401

510(k) Number K102401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2010
Decision Date July 20, 2011
Days to Decision 330 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
208d slower than avg
Panel avg: 122d · This submission: 330d
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 K102401.
HemiCAP MTP Resurfacing Hemi-Arthroplasty System
K152454 · Arthrosurface, Inc. · Apr 2016
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
K131377 · Arthrosurface, Inc. · Nov 2013
BIOPRO HEMI-EDGE TOE SYSTEM
K121973 · Biopro, Inc. · Oct 2012
ASCENSION METAL GREAT TOE SYSTEM
K092047 · Ascension Orthopedics, Inc. · Jan 2010
OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING
K081876 · Osteomed LP · Aug 2008
SBI SR MTP TOE IMPLANT
K073635 · Small Bone Innovations, Inc. · Mar 2008