# K220459: Mako Total Knee Application

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Apr 15, 2022 after 57 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K241011: Mako Total Knee Application (2024), 5 descendants of its own
- 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

## 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
- Apr 15, 2024 · Class II · Z-1912-2024: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdo
- Apr 15, 2024 · Class II · Z-1910-2024: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdo
- Apr 15, 2024 · Class II · Z-1911-2024: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdo
- Apr 15, 2024 · Class II · Z-1914-2024: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdo
- Apr 15, 2024 · Class II · Z-1913-2024: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdo
- Apr 15, 2024 · Class II · Z-1915-2024: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdo

Source page: https://510kreport.com/device/K220459
Methodology: https://510kreport.com/methodology