# K080029: Mako Surgical Corp. Patellofemoral Knee Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: May 16, 2008 after 133 days
- Product code: KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3540
- 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 K020841 (2002). 2 ancestors in all.
55 later devices descend from it; 3 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)
- K020841: Avon Patellar Component, Howmedica Osteonics Corp. (2002) Summary page 1.
- K041160: Avon Extra-Small Patello-Femoral Replacement, Howmedica Osteonics Corp. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K010900: STS-T Lithotripter, Model STS-T, Medstone Intl., Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens, CooperVision, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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
The MAKO Surgical Corp. Patellofemoral Knee Implant System is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. These components are single use only and are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K080029
Methodology: https://510kreport.com/methodology