Cleared Traditional

K014164 - GREAT TOE IMPLANT SYSTEM

K014164 is an FDA 510(k) clearance for GREAT TOE IMPLANT SYSTEM, manufactured by Harmos Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KWD cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K014164 · Harmos Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
83d
Days
Class 2
Risk

K014164 is an FDA 510(k) clearance for the GREAT TOE IMPLANT SYSTEM. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Harmos Orthopaedics, Inc. (Cantonville, US). The FDA issued a Cleared decision on March 12, 2002 after a review of 83 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 Harmos Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K014164

510(k) Number K014164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2001
Decision Date March 12, 2002
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 32
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K014164.
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
K031859 · Arthrosurface, Inc. · Feb 2004
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319 · Wrightmedicaltechnologyinc · Nov 2003
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
K023770 · Kinetikos Medical, Inc. · Dec 2002
FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT
K971047 · Nexa Orthopedics, Inc. · Jun 1997
TOWNLEY GREAT TOE JOINT
K911378 · Biopro, Inc. · Nov 1991
SWANSON TITANIUM GREAT TOE IMPLANT
K864492 · Dow Corning Wright · Apr 1987