# K241011: Mako Total Knee Application

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Jun 11, 2024 after 60 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K220459 (2022). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220459: Mako Total Knee Application, Mako Surgical Corp. (2022) Summary page 4.

## Most influential descendants
- K241517: Q Guidance System; Mako Spine System; (2024), 2 descendants of its own
- K252871: Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories (2026), 1 descendant of its own
- K250608: Mako Total Knee Application (3.0); Hybrid Tip Pointer (2025), 1 descendant of its own
- K260222: Mako Total Knee Application (2026), 0 descendants of its own
- K253623: Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor (2026), 0 descendants of its own

## Recalls of this device
- Feb 2, 2026 · Class II · Z-1572-2026: A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen

## 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 cemented and cementless primary) • Triathlon Total Knee System (TS inserts cemented primary)

Source page: https://510kreport.com/device/K241011
Methodology: https://510kreport.com/methodology