# K060017: Mako Surgical Unicondylar Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Feb 23, 2006 after 50 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: 1 generation back to K032824 (2003). 1 ancestor in all.
58 later devices descend from it; 2 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032824: Stelkast Unicondylar Knee System, Stelkast Company (2003) Summary page 1.

## Most influential descendants
- K073248: Modification to:Mako Surgical Unicondylar Knee System (2007), 57 descendants of its own
- K080368: Mako Surgical Corp. Unicondylar Knee Implant System II (2008), 56 descendants of its own
- 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

## Indications for use
The MAKO Surgical Unicondylar Knee is a single use device intended for cemented reconstruction of the medial or lateral femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis provided there is evidence of sufficient bone to seat the implant. Indications for use include moderate joint impairment from painful arthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy in patients with unicompartmental arthritis.

Source page: https://510kreport.com/device/K060017
Methodology: https://510kreport.com/methodology