Integra® BioMotion® Cannulated Hemi System BIOMOTIONIMP

GUDID M268BIOMOTIONIMP1

The Integra BioMotion Cannulated Hemi System is a partial joint replacement system for the first metatarsophalangeal joint (MPJ). Implants are available in sizes ranging from 15mm to 23mm. The system includes instruments to facilitate the placement of the implants. All implants are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The BioMotion hemi implant is indicated for use in the treatment of degenerative arthritis in the first MPJ along with hallux limitus/rigidus, hallux valgus and pain or instability.

Ascension Orthopedics, Inc.

Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece Total metatarsophalangeal joint prosthesis, one-piece

• Primary Device ID: M268BIOMOTIONIMP1
• NIH Device Record Key: b55a5fca-ed68-49ed-b47b-42f8fe058f17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® BioMotion® Cannulated Hemi System
• Version Model Number: BIOMOTIONIMP
• Catalog Number: BIOMOTIONIMP
• 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: true
• 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
• 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	10381780074274 [Primary]
HIBCC	M268BIOMOTIONIMP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083469

FDA Product Code

• KWD: PROSTHESIS, TOE, HEMI-, PHALANGEAL

Sterilization

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

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

[M268BIOMOTIONIMP1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-21
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra® BioMotion® Cannulated Hemi System]

• 10381780116394: The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
• 10381780116387: The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
• 10381780116370: The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
• 10381780116363: The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
• 10381780116356: The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
• M268BIOMOTIONIMP1: The Integra BioMotion Cannulated Hemi System is a partial joint replacement system for the first