Identity
- Trade Name
- Cadence™ FDA UDI
- Generic Name
- Fixed-bearing total ankle prosthesis FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 10209508 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 10209508 FDA UDI
- Primary DI / UDI-DI
- 10381780239017 FDA UDI
- 510(k) Number
- K151459 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Fixed-bearing total ankle prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fixed-bearing total ankle prosthesis
Cadence™ by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixed-bearing total ankle prosthesis.
- INBONE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- APEX 3D S Total Ankle Replacement System — Paragon 28 · Class II
- INFINITY — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- QUANTUM — IN2BONES · Class II
- INFINITY™ EVERLAST™ — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- APEX 3D Total Ankle Replacement System — Paragon 28 · Class II
- XT Revision Ankle Replacement System — Smith & Nephew, Inc. · Class II
- Salto Talaris Total Ankle Prosthesis — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K151459 also covers:
- Cadence™ — Ascension Orthopedics, Inc.
- Cadence™ — Ascension Orthopedics, Inc.
- Cadence™ — Ascension Orthopedics, Inc.
- Cadence™ — Ascension Orthopedics, Inc.
- Cadence™ — Ascension Orthopedics, Inc.
- Cadence™ — Ascension Orthopedics, Inc.
- Cadence™ — Ascension Orthopedics, Inc.
- Cadence™ — Ascension Orthopedics, Inc.
- Cadence™ — Ascension Orthopedics, Inc.
- Cadence™ — Ascension Orthopedics, Inc.
- Cadence™ — Ascension Orthopedics, Inc.
- Cadence™ — Ascension Orthopedics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 17b537f2-de24-48a9-a9e0-cf78b1a62c61 39 fields · synced May 31, 2026