Cadence™ - The Cadence™ Insert components are made out of - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, ri 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.

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More Product Details

Catalog Number

10209242

Brand Name

Cadence™

Version/Model Number

10209242

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K151459

Product Code Details

Product Code

HSN

Product Code Name

PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Record Status

Public Device Record Key

079364de-621b-4336-b884-12b35a2c811a

Public Version Date

September 16, 2019

Public Version Number

3

DI Record Publish Date

January 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASCENSION ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1909
2 A medical device with a moderate to high risk that requires special controls. 1404
3 A medical device with high risk that requires premarket approval 12
U Unclassified 15