Restoris Porous Partial Knee System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133811 FDA 510(k)
- FDA Product Code
- NJD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3535 FDA 510(k)
- Regulation Number
- 888.3535 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The RESTORIS POROUS PARTIAL KNEE SYSTEM is a unicompartmental knee prosthesis designed for femorotibial joint replacement. It is an uncemented, porous-coated metal and polymer implant intended for partial knee resurfacing.
This device is supplied in a non-sterile condition and requires sterilization prior to use. It is intended for single-patient use and is not MRI safe. The system is available in multiple sizes as specified in the manufacturer's labeling. Authorization is based on FDA 510(k) clearance under product code NJD and regulation number 888.3535.
Frequently asked questions
What is the RESTORIS Porous Partial Knee System used for?
The RESTORIS Porous Partial Knee System is a unicompartmental knee prosthesis designed for femorotibial joint replacement, intended for partial knee resurfacing in patients requiring uncemented, porous-coated metal and polymer implantation.
How is the RESTORIS Porous Partial Knee System supplied and prepared for use?
The device is supplied in a non-sterile condition and must be sterilized by the user prior to implantation, as it is not provided sterile from the manufacturer.
Is the RESTORIS Porous Partial Knee System intended for single use or reuse?
The system is intended for single-patient use only and is not designed for reprocessing or reuse after implantation.
What sizes and models are available for the RESTORIS Porous Partial Knee System?
The system is available in multiple sizes as specified in the manufacturer's labeling, though exact size dimensions are not detailed in the provided data.
What regulatory pathway was used for the RESTORIS Porous Partial Knee System?
Authorization for the RESTORIS Porous Partial Knee System is based on FDA 510(k) clearance under product code NJD and regulation number 888.3535, with a traditional clearance decision.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133811 | Class II | Active |
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Manufacturer
- Manufacturer
- MAKO Surgical Corp.
Sources (1)
- FDA 510(k) K133811 24 fields · synced Sep 23, 2026