# K150410: Restoris Porous Partial Knee System

- Pathway: 510(k) (Special)
- Applicant: Mako Surgical Corporation
- Decided: Mar 20, 2015 after 30 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K943462 (1994). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133811: Restoris Porous Partial Knee System, Mako Surgical Corp. (2014) Summary page 5.

## Indications for use
The Restoris® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions: * Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis. * Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis. * As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. The Restoris® Porous Femoral Component and PST® Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. The implants are single-use devices.

Source page: https://510kreport.com/device/K150410
Methodology: https://510kreport.com/methodology