Cleared Traditional

K073065 - OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM

K073065 is an FDA 510(k) clearance for OSTEOMED METATARSAL RESURFACING IMPLANT..., manufactured by Osteomed LP. The device is a Class 2 Orthopedic device with product code KWD cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K073065 · Osteomed LP · Orthopedic device
Download Printable Device Report (PDF)
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Feb 2008
Decision
114d
Days
Class 2
Risk

K073065 is an FDA 510(k) clearance for the OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Osteomed LP (Addison, US). The FDA issued a Cleared decision on February 21, 2008 after a review of 114 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Osteomed LP devices

FDA 510(k) Submission Details - K073065

510(k) Number K073065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2007
Decision Date February 21, 2008
Days to Decision 114 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
8d faster than avg
Panel avg: 122d · This submission: 114d
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 35
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K073065.
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
3S HEMI TOE
K072922 · Trilliant Surgical, Ltd. · Nov 2007
METAL HEMI IMPLANT
K071243 · Orthopro, LLC · May 2007
MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION
K070052 · Vilex, Inc. · Mar 2007