Movement®

GUDID M268MOVEMNTINSTP1

The Movement Great Toe System is used for hemi- and total-arthroplasty procedures. The hemi arthroplasty is intended for resurfacing of the 1st metatarsal head or the base of the proximal phalanx. The total arthroplasty is intended for resurfacing of the base of the 1st metatarso-phalangeal joint. This set includes metatarsal, proximal phalanx hemi, and proximal phalanx total trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials.

Ascension Orthopedics, Inc.

General external orthopaedic fixation system implantation kit, reusable

• Primary Device ID: M268MOVEMNTINSTP1
• NIH Device Record Key: 92663a1a-ca3c-48a0-8ba4-825ac8375243
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Movement®
• Version Model Number: MOVEMNTINSTP
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: +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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780234999 [Primary]
HIBCC	M268MOVEMNTINSTP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092047

FDA Product Code

• KWD: PROSTHESIS, TOE, HEMI-, PHALANGEAL

Sterilization

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

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

[M268MOVEMNTINSTP1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-02
• Device Publish Date: 2016-08-15

On-Brand Devices [Movement®]

• 10381780363767: Great Toe System MGT Trial Caddy Lid (Green)
• 10381780363750: Great Toe System MGT Trial Caddy
• 10381780363743: Great Toe System MGT Base (Case)
• M269PSR89030401: Movement® Great Toe System Proximal Phalanx Surface Reamer Sz. 30/4 The Movement Great Toe prox
• M269PSR89010201: Movement® Great Toe System Proximal Phalanx Surface Reamer Sz. 10/2 The Movement Great Toe prox
• M269MSR89030401: Movement® Great Toe System Metatarsal Surface Reamer Sz. 30/40 The Movement Great Toe metatarsa
• M269MSR89010201: Movement® Great Toe System Metatarsal Surface Reamer Sz. 10/20 The Movement Great Toe metatarsa
• M269DRL890001: Movement® Great Toe System The cannulated drill is used with the Movement Great Toe System.
• M269DCG890001: Movement® Great Toe System The Metatarsal Dorsal Cut Guide allows for precise cheilectomy of do
• M268MOVEMNTINSTP1: The Movement Great Toe System is used for hemi- and total-arthroplasty procedures. The hemi arth
• M269GDW890001: Movement® Great Toe System The guide pin assists with the placement of implants in the great to