KGTI™ Kinetik Great Toe Implant System 012005

GUDID M2480120051

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.

INTEGRA LIFESCIENCES CORPORATION

Partial metatarsophalangeal joint prosthesis

• Primary Device ID: M2480120051
• NIH Device Record Key: 99b9dc20-7c10-4b45-8a63-0f07eeba527f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KGTI™ Kinetik Great Toe Implant System
• Version Model Number: 012005
• Catalog Number: 012005
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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• Email: custsvcnj@integralife.com
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• Email: custsvcnj@integralife.com
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• Email: custsvcnj@integralife.com
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• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780065425 [Primary]
HIBCC	M2480120051 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924724

FDA Product Code

• LZJ: Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-26
• Device Publish Date: 2017-10-09

On-Brand Devices [KGTI™ Kinetik Great Toe Implant System]

• M2480150901: PHALANGEAL REAMER
• M2480150801: M/P REAMER
• M2480120161: The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary
• M2480120141: The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary
• M2480120121: The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary
• M2480120071: The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea
• M2480120061: The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea
• M2480120051: The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea
• M2480120041: The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea
• M2480120021: The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea