Cleared Special

K023770 - K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)

K023770 is an FDA 510(k) clearance for K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZO..., manufactured by Kinetikos Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWD cleared through the Special 510(k) pathway after a 30-day FDA review.

K023770 · Kinetikos Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
30d
Days
Class 2
Risk

K023770 is an FDA 510(k) clearance for the K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM). Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Kinetikos Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on December 12, 2002 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.

FDA 510(k) Submission Details - K023770

510(k) Number K023770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2002
Decision Date December 12, 2002
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.

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 K023770.
CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365
K023684 · Vilex, Inc. · Mar 2004
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
K031859 · Arthrosurface, Inc. · Feb 2004
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319 · Wrightmedicaltechnologyinc · Nov 2003
GREAT TOE IMPLANT
K021063 · Signal Medical Corp. · Jul 2002
GREAT TOE IMPLANT SYSTEM
K014164 · Harmos Orthopaedics, Inc. · Mar 2002
MTP RESESURFACING JOINT-SMALL/9301-01
K003629 · Terray Corp. · Feb 2001
K023770 · K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
Download PDF FDA Summary Kinetikos Medical, In…