Identity
- Trade Name
- KGTI™ Kinetik Great Toe Implant System FDA UDI
- Generic Name
- Partial metatarsophalangeal joint prosthesis FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 012012 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 012012 FDA UDI
- Primary DI / UDI-DI
- 10381780065463 FDA UDI
- 510(k) Number
- K924724 FDA UDI
- FDA Product Code
- LZJ FDA UDI
- GMDN Term
- Partial metatarsophalangeal joint prosthesis FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
KGTI™ Kinetik Great Toe Implant System by Ascension Orthopedics, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI aa73717e-a8ce-41b7-8510-ee51f231a78c 39 fields · synced May 31, 2026