Cleared Special

METAL HEMI IMPLANT (K071243) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K071243 · Orthopro, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
20d
Days
Class 2
Risk

K071243 is an FDA 510(k) clearance for the METAL HEMI IMPLANT. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Orthopro, LLC (Round Rock, US). The FDA issued a Cleared decision on May 23, 2007 after a review of 20 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 Orthopro, LLC devices

Submission Details

510(k) Number K071243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2007
Decision Date May 23, 2007
Days to Decision 20 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 122d · This submission: 20d
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 11
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K071243.
BOSS Toe Fixation System
K190261 · Arthrosurface, Inc. · Aug 2019
Cannulated Hemi Implant
K190543 · Vilex IN Tennessee, Inc. · May 2019
Life Spine Metatarsal Hemi Implant
K161279 · Life Spine, Inc. · Feb 2017
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
K063058 · Arthrex, Inc. · Jan 2007
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319 · Wrightmedicaltechnologyinc · Nov 2003