# K242373: Mako Shoulder Application (1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Nov 7, 2024 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: 14 generations back to K905070 (1991). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172301: Mako Partial Knee Application, Mako Surgical Corp. (2017) 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 shoulder 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 patient imaging data-based model of the anatomy. These procedures include: • Reverse Shoulder Arthroplasty (primary joint replacement) The implants compatible with the system are: • Aequalis PerFORM Reversed Glenoid (cementless) • Aequalis PerFORM + Reversed Glenoid (cementless)

Source page: https://510kreport.com/device/K242373
Methodology: https://510kreport.com/methodology