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Attune
FDA UDIEUDAMEDClass III (US FDA UDI)
Ref 1506-10-005Model ATTUNE Knee System Cemented RP Tibial Base
Identity
- Trade Name
- ATTUNE FDA UDI
- Generic Name
- Uncoated knee tibia prosthesis, metallic FDA UDI
- Device Name
- Cemented RP Tibial Base EUDAMEDATTUNE KNEE SYSTEM TIBIAL BASE ROTATING PLATFORM SIZE 5 CEMENTED FDA UDI
- Model / Reference
- 1506-10-005 EUDAMEDFDA UDIATTUNE Knee System Cemented RP Tibial Base EUDAMED
- Description
- ATTUNE KNEE SYSTEM TIBIAL BASE ROTATING PLATFORM SIZE 5 CEMENTED FDA UDI
Identifiers
- Catalog Number
- 150610005 FDA UDI
- Primary DI / UDI-DI
- 10603295042594 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a002578V EUDAMED
- FDA Product Code
- NJL FDA UDI
- EMDN Code
- P090903020101 BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED MOBILE BEARING TIBIAL PLATES EUDAMED
- GMDN Term
- Uncoated knee tibia prosthesis, metallic FDA UDI
Classification
- Device Class
- Class III EUDAMEDFDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Conditional FDA UDI
Category: Uncoated knee tibia prosthesis, metallic
Attune by Depuy (ireland) — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated knee tibia prosthesis, metallic.
- Natural-Knee® — Zimmer, Inc. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Biomet® Knee System — Biomet Orthopedics, Inc. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Depuy (ireland)
Sources (2)
- FDA UDI e9bdd78b-5b05-45e5-aca3-a3050753575e 35 fields · synced Aug 1, 2026
- EUDAMED 1c70ab10-f393-4a13-9f5d-e541c932c047 61 fields · synced Aug 1, 2026