Cleared Traditional

K070052 - MET-HEAD MODEL# MHDD-XX:CC DIAMETER

K070052 is an FDA 510(k) clearance for MET-HEAD MODEL# MHDD-XX:CC DIAMETER, 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 83-day FDA review.

K070052 · Vilex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
83d
Days
Class 2
Risk

K070052 is an FDA 510(k) clearance for the MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Vilex, Inc. (Pleasant Hills, US). The FDA issued a Cleared decision on March 28, 2007 after a review of 83 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 Vilex, Inc. devices

FDA 510(k) Submission Details - K070052

510(k) Number K070052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2007
Decision Date March 28, 2007
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 K070052.
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