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KGTI™ Kinetik Great Toe Implant System

Ascension Orthopedics, Inc. · Model 012012 · UDI-DI 10381780065463

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary canal of the phalanx. 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2014-06-09	Arthrosurface, Inc.	An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.

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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.