# K191998: Mako Total Hip Application, Mako Total Knee Application

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Sep 24, 2019 after 60 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: 14 generations back to K905070 (1991). 56 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170593: Mako Total Hip Application, Mako Surgical Corp. (2017) Summary page 6.
- K172219: Mako Total Knee Application, Mako Surgical Corp. (2017) Summary page 9.

## Most influential descendants
- K193128: Mako Total Hip Application (2020), 3 descendants of its own
- K243751: Mako Total Hip Application 5.0 (2025), 1 descendant of its own
- K193515: Mako Total Knee Application (2020), 1 descendant of its own
- K252847: NextAR Hip Platform (2026), 0 descendants of its own
- K240721: ExcelsiusFlex™ (2024), 0 descendants of its own

## 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 cemented and cementless primary) • Triathlon Total Knee System (TS inserts cemented primary) • Kinetis Total Knee System (CR/UC) 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 and hip 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: • Unicondylar knee replacement and/or patellofemoral knee replacement • Total Hip Arthroplasty (THA)

Source page: https://510kreport.com/device/K191998
Methodology: https://510kreport.com/methodology