Identity
- Trade Name
- MOTO Partial Knee System - Medial FDA UDI
- Generic Name
- Uncoated unicondylar knee femur prosthesis FDA UDI
- Device Name
- Anatomical Femoral Component Cemented S9 RM FDA UDI
- Model / Reference
- 02.18.009RM FDA UDI
- Description
- Anatomical Femoral Component Cemented S9 RM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030895708 FDA UDI
- 510(k) Number
- K162084 FDA UDI
- FDA Product Code
- HSX FDA UDI
- GMDN Term
- Uncoated 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: Uncoated unicondylar knee femur prosthesis
MOTO Partial Knee System - Medial by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated unicondylar knee femur prosthesis.
- HLS Uni Evolution — CORIN LTD · Class II
- Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
- iUni® Femoral Kit — Conformis, Inc. · Class II
- Persona® Partial Knee System — Biomet Orthopedics, Inc. · Class II
- Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class II
- GENESIS — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K162084 also covers:
- MOTO Partial Knee System - Medial — Medacta International
- MOTO Partial Knee System - Medial — Medacta International
- MOTO Partial Knee System - Medial — Medacta International
- MOTO Partial Knee System - Medial — Medacta International
- MOTO Partial Knee System - Medial — Medacta International
- MOTO Partial Knee System - Medial — Medacta International
- MOTO Partial Knee System - Medial — Medacta International
- MOTO Partial Knee System - Medial — Medacta International
- MOTO Partial Knee System - Medial — Medacta International
- MOTO Partial Knee System - Medial — Medacta International
- MOTO Partial Knee System - Medial — Medacta International
- MOTO Partial Knee System - Medial — 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 6245db7d-dffd-462e-a86b-fc9e530a0d62 34 fields · synced May 30, 2026