Identity
- Trade Name
- MOTO PFJ System FDA UDI
- Generic Name
- Patellofemoral joint prosthesis FDA UDI
- Device Name
- TiNbN coated Patello Femoral Joint S4 R FDA UDI
- Model / Reference
- 02.15.704R FDA UDI
- Description
- TiNbN coated Patello Femoral Joint S4 R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630345705129 FDA UDI
- 510(k) Number
- K213071 FDA UDI
- FDA Product Code
- HSX FDA UDI
- GMDN Term
- Patellofemoral joint 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: Patellofemoral joint prosthesis
MOTO PFJ System by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patellofemoral joint prosthesis.
- KineMatch® PFR System — Kinamed, Inc. · Class II
- PRELUDE PF — Biomet Sports Medicine · Class II
- PRELUDE PF — Biomet Orthopedics, Inc. · Class II
- PRELUDE PF — Biomet Orthopedics, Inc. · Class II
- Gender Solutions® — Zimmer, Inc. · Class II
- Prelude® PF — Biomet Orthopedics, Inc. · Class II
- PRELUDE PF — Biomet Orthopedics, Inc. · Class II
- PRELUDE PF — Biomet Orthopedics, Inc. · 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 Partial Knee 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 10d36d64-a7da-4f26-8314-6eb8768a738a 34 fields · synced Jun 1, 2026