Cleared Special

K081876 - OSTEOMED RESURFACING METATARSAL IMPLANT...

K081876 is the FDA 510(k) clearance for OSTEOMED RESURFACING METATARSAL IMPLANT... by Osteomed LP. It is a Class 2 Orthopedic device (product code KWD) cleared through the Special 510(k) pathway after a 30-day FDA review.

K081876 · Osteomed LP · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
30d
Days
Class 2
Risk

K081876 is an FDA 510(k) clearance for the OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING. 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 August 1, 2008 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Osteomed LP devices

Submission Details

510(k) Number K081876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2008
Decision Date August 01, 2008
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 16
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K081876.
Cannulated Hemi Implant
K190543 · Vilex IN Tennessee, Inc. · May 2019
Life Spine Metatarsal Hemi Implant
K161279 · Life Spine, Inc. · Feb 2017
BIOPRO HEMI-EDGE TOE SYSTEM
K121973 · Biopro, Inc. · Oct 2012
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
K063058 · Arthrex, Inc. · Jan 2007
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
K041595 · Biopro, Inc. · Nov 2004
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319 · Wrightmedicaltechnologyinc · Nov 2003