Cleared Traditional

K062908 - ORTHROPRO HEMI TOE

K062908 is an FDA 510(k) clearance for ORTHROPRO HEMI TOE, manufactured by Orthopro, LLC. The device is a Class 2 Orthopedic device with product code KWD cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K062908 · Orthopro, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
47d
Days
Class 2
Risk

K062908 is an FDA 510(k) clearance for the ORTHROPRO HEMI TOE. 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 November 13, 2006 after a review of 47 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 Orthopro, LLC devices

FDA 510(k) Submission Details - K062908

510(k) Number K062908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2006
Decision Date November 13, 2006
Days to Decision 47 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
75d faster than avg
Panel avg: 122d · This submission: 47d
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 K062908.
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
OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
K060536 · Osteomed LP · Jun 2006
ASCENSION PYROSPHERE CMC/TMT
K060560 · Ascension Orthopedics, Inc. · May 2006