# K080368: Mako Surgical Corp. Unicondylar Knee Implant System II

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Jun 20, 2008 after 129 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K971938 (1997). 16 ancestors in all.
56 later devices descend from it; 2 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 1.
- K992287: First Step Unicompartmental Knee System, Howmedica Osteonics Corp. (1999) Summary page 1.
- K033769: Eius Unicompartmental Knee System, Howmedica Osteonics Corp. (2004) Summary page 1.
- K020741: Unicondylar Knee, Encore Orthopedics, Inc. (2002) Summary page 1.
- K022437: Uni Knee, Encore Medical L.P. (2002) Summary page 1.
- K971938: Repicci II Unicondylar Knee, Biomet, Inc. (1997) Summary page 1.
- K060017: Mako Surgical Unicondylar Knee System, Mako Surgical Corp. (2006) Summary page 1.
- K073248: Modification to:Mako Surgical Unicondylar Knee System, Mako Surgical Corp. (2007) Summary page 1.

## Most influential descendants
- K082172: Mako Modular Knee Compartmental Implant System (2008), 51 descendants of its own
- K090763: Restoris Multicompartmental Knee (MCK) System (2009), 50 descendants of its own
- K133039: Restoris Multicompartmental Knee System (2013), 26 descendants of its own
- K150307: RESTORIS Multicompartmental Knee System (2015), 25 descendants of its own
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own

## Indications for use
MAKO Surgical Corp. Unicondylar Knee Implant System II components are for use in unicompartmental knee arthroplasty as a result of: * Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis * Revision of previous unsuccessful unicompartmental knee replacement * As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis These components are single use only and are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K080368
Methodology: https://510kreport.com/methodology