Identity
- Trade Name
- RESTORIS ESYNTIAL FDA UDI
- Generic Name
- Unicondylar knee prosthesis FDA UDI
- Device Name
- MCK Onlay Tibial Insert FDA UDI
- Model / Reference
- 180741-5 FDA UDI
- Description
- MCK Onlay Tibial Insert FDA UDI
Identifiers
- Catalog Number
- 180741-5 FDA UDI
- Primary DI / UDI-DI
- 00848486015190 FDA UDI
- 510(k) Number
- K133039 FDA UDI
- FDA Product Code
- KRR FDA UDINPJ FDA UDIHRY FDA UDIHSX FDA UDIOIY FDA UDI
- GMDN Term
- Unicondylar knee prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3540 FDA UDI888.3560 FDA UDI888.3530 FDA UDI888.3520 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: Unicondylar knee prosthesis
Restoris Esyntial by MAKO Surgical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Unicondylar knee prosthesis.
- Engage Partial Knee System — Engage Uni, LLC · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- Oxford® Partial Knee System — Biomet Orthopedics, Inc. · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- GENESIS II — Smith & Nephew, Inc. · Class II
- OvertureTi — OVERTURE ORTHOPAEDICS · Class II
- Arthrex® — Arthrex, Inc. · Class II
Cleared under the same submission
K133039 also covers:
- RESTORIS ESYNTIAL — MAKO Surgical Corp.
- RESTORIS ESYNTIAL — MAKO Surgical Corp.
- RESTORIS ESYNTIAL — MAKO Surgical Corp.
- RESTORIS ESYNTIAL — MAKO Surgical Corp.
- RESTORIS ESYNTIAL — MAKO Surgical Corp.
- RESTORIS ESYNTIAL — MAKO Surgical Corp.
- RESTORIS ESYNTIAL — MAKO Surgical Corp.
- RESTORIS ESYNTIAL — MAKO Surgical Corp.
- RESTORIS ESYNTIAL — MAKO Surgical Corp.
- RESTORIS ESYNTIAL — MAKO Surgical Corp.
- RESTORIS ESYNTIAL — MAKO Surgical Corp.
- RESTORIS ESYNTIAL — MAKO Surgical Corp.
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
- MAKO Surgical Corp.
Sources (1)
- FDA UDI 5b7619f4-eb85-456d-b17a-4c9b7e1ea8ca 36 fields · synced Jun 9, 2026