Cleared Special

K071243 - METAL HEMI IMPLANT

K071243 is an FDA 510(k) clearance for METAL HEMI IMPLANT, manufactured by Orthopro, LLC. The device is a Class 2 Orthopedic device with product code KWD cleared through the Special 510(k) pathway after a 20-day FDA review.

K071243 · Orthopro, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K071243

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 42
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K071243.
SBI SR MTP TOE IMPLANT
K073635 · Small Bone Innovations, Inc. · Mar 2008
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM
K073065 · Osteomed LP · Feb 2008
3S HEMI TOE
K072922 · Trilliant Surgical, Ltd. · Nov 2007
MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION
K070052 · Vilex, Inc. · Mar 2007
CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY
K063370 · Arthrosurface, Inc. · Jan 2007
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
K063058 · Arthrex, Inc. · Jan 2007