510(k) · Cleared
Recalled · Class II · 2026Mako Total Knee Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mako Surgical Corp. · OLO Orthopedic Stereotaxic Instrument
Cleared on Apr 15, 2022 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 7 times.
- Decided
- Apr 15, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 7
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK220459 Mako Total Knee ApplicationMako Surgical Corp. · 2022
- Descendant · cites it directly · 5 of its ownK241011 Mako Total Knee ApplicationMako Surgical Corp. · 2024 · Recalled
- Descendant · 2 generations on · 2 of its ownK241517 Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024
- Descendant · 3 generations on · 1 of its ownK252871 Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q…Stryker Leibinger GmbH & Co KG · 2026
- Descendant · 2 generations on · 1 of its ownK250608 Mako Total Knee Application (3.0); Hybrid Tip PointerMako Surgical Corp. · 2025
- Descendant · 3 generations on · 0 of its ownK260222 Mako Total Knee ApplicationMako Surgical Corp. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K241011Mako Total Knee ApplicationMako Surgical Corp. · 2024 · cites it directly5descendants
- K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024 · 2 generations on2descendants
- K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG · 2026 · 3 generations on1descendant
- K250608Mako Total Knee Application (3.0); Hybrid Tip PointerMako Surgical Corp. · 2025 · 2 generations on1descendant
- K260222Mako Total Knee ApplicationMako Surgical Corp. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K220459 | Mako Total Knee Application | Mako Surgical Corp. | 2022 | — |
| +1 | K241011 | Mako Total Knee Application | Mako Surgical Corp. | 2024 | 1 |
| +2 | K241517 | Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +3 | K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments… | Stryker Leibinger GmbH & Co KG | 2026 | — |
| +2 | K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | Mako Surgical Corp. | 2025 | — |
| +3 | K260222 | Mako Total Knee Application | Mako Surgical Corp. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241011 | Mako Total Knee Application | 2024 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2026 | Class II | Z-1572-2026 | Under Investigation by firm | 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 during use and detach from the… |
| Apr 15, 2024 | Class II | Z-1912-2024 | Device Design | 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 shutdown or a Mako System restart is not… |
| Apr 15, 2024 | Class II | Z-1910-2024 | Device Design | 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 shutdown or a Mako System restart is not… |
| Apr 15, 2024 | Class II | Z-1911-2024 | Device Design | 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 shutdown or a Mako System restart is not… |
| Apr 15, 2024 | Class II | Z-1914-2024 | Device Design | 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 shutdown or a Mako System restart is not… |
| Apr 15, 2024 | Class II | Z-1913-2024 | Device Design | 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 shutdown or a Mako System restart is not… |
| Apr 15, 2024 | Class II | Z-1915-2024 | Device Design | 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 shutdown or a Mako System restart is not… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K241011 (Mako Surgical Corp., 2024) has gone furthest, with 5 descendants of its own.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
https://510kreport.com/device/K220459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220459: Mako Total Knee Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220459
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026