# K082088: Mako Surgical Corp. Patellofemoral Knee Implant System II

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Oct 22, 2008 after 90 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: 2 generations back to K020841 (2002). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 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 1.
- K010100: Avon Patello-Femoral Joint Prosthesis, Howmedica Osteonics Corp. (2001)
- 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.
- K051948: Avon Patello-Femoral Joint Prosthesis, Howmedica Osteonics Corp. (2005) Summary page 1.

## Most influential descendants
- K123907: Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella Components, (2013), 1 descendant of its own
- K143543: Prelude PF Patellae (2015), 0 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/K082088
Methodology: https://510kreport.com/methodology