KGTI™ Kinetik Great Toe Implant System 012003

GUDID M2480120031

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.

Ascension Orthopedics, Inc.

Partial metatarsophalangeal joint prosthesis

• Primary Device ID: M2480120031
• NIH Device Record Key: 3638d409-b904-4433-8f18-1929c3f0339d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KGTI™ Kinetik Great Toe Implant System
• Version Model Number: 012003
• Catalog Number: 012003
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• 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

• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Email: custsvcnj@integralife.com

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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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.
• Special Storage Condition, Specify: Between 0 and 0 * 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	10381780065401 [Primary]
HIBCC	M2480120031 [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: 2021-03-04
• Device Publish Date: 2017-10-09

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

• M2480150541: METATARSAL BROACH LEFT POWER
• M2480150521: METATARSAL BROACH RIGHT POWER
• M2480151161: TRIAL SIZE 3 PHALANGEAL
• M2480151141: TRIAL SIZE 2 PHALANGEAL
• M2480151121: TRIAL SIZE 1 PHALANGEAL
• M2480151101: TRIAL SIZE 0 PHALANGEAL
• M2480151061: TRIAL SIZE 3 METATARSAL
• M2480151041: TRIAL SIZE 2 METATARSAL
• M2480151021: TRIAL SIZE 1 METATARSAL
• M2480150701: METATARSAL IMPACTOR
• M2480150551: METATARSAL BROACH LEFT MANUAL
• M2480150531: METATARSAL BROACH RIGHT MANUAL
• M2480150431: METATARSAL BROACH GUIDE LEFT
• M2480150411: METATARSAL BROACH GUIDE RIGHT
• M2480150321: DORSAL FLANGE RESECTION GUIDE
• M2480150221: PHALANGEAL SIZER DRILL GUIDE
• M2480150201: METATARSAL SIZER DRILL GUIDE
• M2480150141: INSTRUMENT HANDLE 90º
• M2480150101: INSTRUMENT HANDLE SMALL
• M2480150041: PRIMARY RESECTION GUIDE 5MM
• M2480150021: PRIMARY RESECTION GUIDE NEUTRAL
• M2480150011: KGTI STERILIZATION CASE
• M2480120101: The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary
• M2480120031: The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea