Cadence™ 10209328

GUDID M268102093281

The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidly fixed to the Tibial Tray intra-operatively. In conjunction with the Talar Dome and Tibial Tray, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.

Ascension Orthopedics, Inc.

Fixed-bearing total ankle prosthesis

• Primary Device ID: M268102093281
• NIH Device Record Key: 9bb3c974-d3bf-457b-bcb9-bcfea8eecf76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cadence™
• Version Model Number: 10209328
• Catalog Number: 10209328
• 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: false
• 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: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment. Protect from sunlight and extreme temperatures.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780239710 [Primary]
HIBCC	M268102093281 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151459

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-16
• Device Publish Date: 2016-01-12

On-Brand Devices [Cadence™]

• M268102031961: U-Joint is used to remove the Tibial Tray from the talus when the Slap Hammer is not sufficient.
• M268102030281: Cadence Talar Implant Extractor is used to remove the Talar Dome implant from the implant site.
• M268102030071: Cadence Insert Inserter is used to properly insert and position the insert implant on the anteri
• M268102095421: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095411: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095401: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095391: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095381: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095371: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095361: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095321: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095311: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095301: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095291: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095281: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095271: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095261: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094421: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094411: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094401: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094391: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094381: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094371: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094361: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094321: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094311: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094301: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094291: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094281: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094271: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094261: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093421: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093411: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M28102093401: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093391: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093381: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093371: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093361: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093321: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093311: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093301: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093291: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093281: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093271: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093261: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102092421: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102092411: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102092401: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102092391: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102092381: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl