AccessGUDID - DEVICE: KGTI™ Kinetik Great Toe Implant System (10381780065425)

GUDID

Device Identifier (DI) Information

Brand Name: KGTI™ Kinetik Great Toe Implant System
Version or Model: 012005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 012005
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780065425
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33696	Partial metatarsophalangeal joint prosthesis	An implantable artificial substitute for the distal head of the metatarsal or the adjacent phalangeal base, intended to repair an articulating surface of the metatarsophalangeal (MTP) joint of the foot (toe). The device is made of metal or a metal/polymer combination, and may contain hyaluronic acid; implantation may be performed with or without bone cement. The device is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LZJ	Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K924724	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: .89 in L x .733 in W; Size 2

Device Record Status

Public Device Record Key: 99b9dc20-7c10-4b45-8a63-0f07eeba527f
Public Version Date: May 02, 2023
Public Version Number: 7
DI Record Publish Date: October 09, 2017