Unity Total Knee System
FDA UDIEUDAMEDClass II (US FDA UDI)
by Corin Ltd
Identity
- Trade Name
- Unity Knee CR Femur Size 8/Right Cruciate Retaining-CoCr (For Cemented use) EUDAMEDUnity Total Knee System FDA UDI
- Generic Name
- Uncoated hip femur prosthesis, modular FDA UDI
- Device Name
- Unity Knee Cruciate-Retaining CoCr Femoral Component for Cemented Total Knee Arthroplasty EUDAMEDUnity Femoral CR Component Cemented Size 8 Right FDA UDI
- Model / Reference
- 112.001.36 EUDAMEDFDA UDIUnity Total Knee System EUDAMED
- Description
- Unity Femoral CR Component Cemented Size 8 Right FDA UDI
Identifiers
- Catalog Number
- 112.001.36 FDA UDI
- Primary DI / UDI-DI
- 05055343872512 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055343872512 EUDAMED
- 510(k) Number
- K113060 FDA UDI
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- P0909030101 BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS EUDAMED
- GMDN Term
- Uncoated hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Uncoated hip femur prosthesis, modular
Unity Total Knee System by Corin Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated hip femur prosthesis, modular.
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- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
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Cleared under the same submission
K113060 also covers:
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Corin Ltd
Sources (2)
- FDA UDI d263ab5e-a820-4cec-abde-e07869cd1204 36 fields · synced Oct 8, 2026
- EUDAMED 5e5514f5-940b-4838-ac2c-48f707ba8a41 61 fields · synced Oct 8, 2026