# K082081: Mako Surgical Corporation Unicondylar Knee Implant System Iii - Pathway: 510(k) (Traditional) - Applicant: Mako Surgical Corp. - Decided: Oct 15, 2008 after 84 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: 4 generations back to K971938 (1997). 17 ancestors in all. 12 later devices descend from it; 1 cites it directly. 0 of 30 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K020741: Unicondylar Knee, Encore Orthopedics, Inc. (2002) Summary page 1. - K022437: Uni Knee, Encore Medical L.P. (2002) Summary page 1. - K080368: Mako Surgical Corp. Unicondylar Knee Implant System II, Mako Surgical Corp. (2008) Summary page 1. - K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 1. ## Most influential descendants - K123380: Stride Unicondylar Knee (2013), 11 descendants of its own - K163700: Bodycad Unicompartmental Knee System (2017), 8 descendants of its own - K181302: Bodycad Unicompartmental Knee System (2019), 7 descendants of its own - K191150: Bodycad Unicompartmental Knee System (2019), 4 descendants of its own - K191996: BC Reflex Uni Knee System (2019), 3 descendants of its own ## Indications for use MAKO Surgical Corp. Unicondylar Knee Implant System III 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/K082081 Methodology: https://510kreport.com/methodology