# K082172: Mako Modular Knee Compartmental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corporation
- Decided: Nov 28, 2008 after 119 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K943462 (1994). 30 ancestors in all.
51 later devices descend from it; 2 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080029: Mako Surgical Corp. Patellofemoral Knee Implant System, Mako Surgical Corp. (2008) Summary page 2.
- K080368: Mako Surgical Corp. Unicondylar Knee Implant System II, Mako Surgical Corp. (2008) Summary page 2.
- K052917: Stryker Compartmental Knee System, Howmedica Osteonics Corp. (2005) Summary page 2.
- K061648: Depuy Graduated Compartmental Knee (GCK), DePuy Orthopaedics, Inc. (2006) Summary page 2.
- K070849: Depuy GCK Femoral and Tibial Components, DePuy Orthopaedics, Inc. (2007) Summary page 2.

## Most influential descendants
- 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
- K133811: Restoris Porous Partial Knee System (2014), 19 descendants of its own

## Recalls of this device
- Mar 10, 2023 · Class II · Z-1386-2023: Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
- Mar 10, 2023 · Class II · Z-1385-2023: Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

## Indications for use
The MAKO Modular Knee Compartmental Implant System is indicated for single or multi-compartmental knee replacement used in conjunction with the MAKO Tactile Guidance System in individuals with osteoarthritis or post traumatic arthritis of the medial tibiofemoral and/or patellofemoral articular surfaces. The MAKO Modular Knee Compartmental Implant System is for single use only and is intended for implantation with bone cement.

Source page: https://510kreport.com/device/K082172
Methodology: https://510kreport.com/methodology