Identity
- Trade Name
- MOTO Partial Knee System FDA UDI
- Generic Name
- Coated unicondylar knee femur prosthesis FDA UDI
- Device Name
- TiNbN coated Anatomical Femur Cemented S10 LM - MEDIAL FDA UDI
- Model / Reference
- 02.18.710LM FDA UDI
- Description
- TiNbN coated Anatomical Femur Cemented S10 LM - MEDIAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630345705426 FDA UDI
- 510(k) Number
- K213071 FDA UDI
- FDA Product Code
- HSX FDA UDI
- GMDN Term
- Coated unicondylar knee femur prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3520 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: Coated unicondylar knee femur prosthesis
MOTO Partial Knee System by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated unicondylar knee femur prosthesis.
- Unicondylar Sled Prosthesis — WALDEMAR LINK GmbH & Co. KG · Class II
- UNI LM/RL XLG — BIOPRO, INC. · Class II
- UNI LM/RL LG — BIOPRO, INC. · Class II
- UNI LL/RM LG — BIOPRO, INC. · Class II
- Unicondylar Sled Prosthesis — WALDEMAR LINK GmbH & Co. KG · Class II
- Alliant Biotech — Medisurge · Class II
- Alliant Biotech — Medisurge · Class II
- Alliant Biotech — Medisurge · Class II
Cleared under the same submission
K213071 also covers:
- MOTO PFJ System — Medacta International
- MOTO PFJ System — Medacta International
- MOTO PFJ System — Medacta International
- MOTO PFJ System — Medacta International
- MOTO PFJ System — Medacta International
- MOTO PFJ System — Medacta International
- MOTO PFJ System — Medacta International
- MOTO PFJ System — Medacta International
- MOTO Partial Knee System — Medacta International
- MOTO Partial Knee System — Medacta International
- MOTO Partial Knee System — Medacta International
- MOTO Partial Knee System — Medacta International
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
- Medacta International
Sources (1)
- FDA UDI 5ffa4124-f638-42c3-b9fb-845eddabcd72 34 fields · synced May 30, 2026