# K260222: Mako Total Knee Application

- Pathway: 510(k) (Special)
- Applicant: Mako Surgical Corp.
- Decided: Feb 25, 2026 after 30 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K220459 (2022). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250608: Mako Total Knee Application (3.0); Hybrid Tip Pointer, Mako Surgical Corp. (2025) Summary page 5.

## Indications for use
The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: * Total Knee Arthroplasty (TKA) The implant systems compatible with the system: * Triathlon Total Knee System (CR/CS/PS/PSR/MS cemented and cementless primary) * Triathlon Total Knee System (TS inserts, cemented primary)

Source page: https://510kreport.com/device/K260222
Methodology: https://510kreport.com/methodology