Cadence™

Basic Information

• Brand Name: Cadence™
• Primary DI: 10381780239604
• Version / Model: 10209231
• Catalog Number: 10209231
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-12
• Public Version: 4
• Public Version Date: 2023-01-25
• Public Version Status: Update
• Public Device Record Key: 8e398238-7e1a-420f-afcf-3edbd5ffc230
• Distribution End Date: 2026-12-31

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSN	PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33718	Fixed-bearing total ankle prosthesis	A sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is attached or moulded to one of the components. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M268102092311	HIBCC
Primary	10381780239604	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K151459	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size 2 Right 11mm Anterior-Biased

Storage Conditions

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