# K133811: Restoris Porous Partial Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Jul 8, 2014 after 204 days
- Product code: NJD (Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3535
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K943462 (1994). 38 ancestors in all.
19 later devices descend from it; 5 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090763: Restoris Multicompartmental Knee (MCK) System, Mako Surgical Corporation (2009) Summary page 1.
- K082172: Mako Modular Knee Compartmental Implant System, Mako Surgical Corporation (2008) Summary page 2.
- K033810: Natural-Knee II Unicompartmental Knee System, Centerpulse Orthopedics, Inc. (2004) Summary page 2.

## Most influential descendants
- K163700: Bodycad Unicompartmental Knee System (2017), 8 descendants of its own
- K181302: Bodycad Unicompartmental Knee System (2019), 7 descendants of its own
- K190439: Engage™ Partial Knee System (2019), 5 descendants of its own
- K191150: Bodycad Unicompartmental Knee System (2019), 4 descendants of its own
- K230653: Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates (2023), 3 descendants of its own

## 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 PSTO 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.

Source page: https://510kreport.com/device/K133811
Methodology: https://510kreport.com/methodology