# K243751: Mako Total Hip Application 5.0

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Mar 5, 2025 after 90 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: 16 generations back to K905070 (1991). 58 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193128: Mako Total Hip Application, Mako Surgical Corp. (2020) Summary page 5.

## Most influential descendants
- K252847: NextAR Hip Platform (2026), 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 total hip arthroplasty 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; including revision total hip arthroplasty procedures where: • the primary acetabular component is well-fixed to the pelvic anatomy, and • the acetabular component can be revised with either a cup or cup and wedge augment construct. These procedures include: Total Hip Arthroplasty (THA)

Source page: https://510kreport.com/device/K243751
Methodology: https://510kreport.com/methodology