Home › Ascension Orthopedics, Inc. › KGTI™ Kinetik Great Toe Implant System

KGTI™ Kinetik Great Toe Implant System

Ascension Orthopedics, Inc. · Model 012005 · UDI-DI 10381780065425

LZJ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.

Recalls

Date	Firm	Reason
2014-06-09	Arthrosurface, Inc.	An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.