510(k) · Cleared

Cleared

Mako Surgical Unicondylar Knee System

K060017510(k) TraditionalCleared Feb 23, 200650-day reviewClass II21 CFR 888.3520

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mako Surgical Corp. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cleared on Feb 23, 2006 as substantially equivalent to K032824 (Stelkast Company, 2003) after a 50-day review. Its family tree reaches back 1 generation to 2003. 58 later devices descend from it.

Decided: Feb 23, 2006
Review: 50 days
Class: Class II
Product code: HSX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K032824 (2003). 58 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK032824 Stelkast Unicondylar Knee SystemStelkast Company · 2003 · Recalled
This deviceK060017 Mako Surgical Unicondylar Knee SystemMako Surgical Corp. · 2006
Descendant · cites it directly · 57 of its ownK073248 Modification to:Mako Surgical Unicondylar Knee SystemMako Surgical Corp. · 2007
Descendant · cites it directly · 56 of its ownK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
Descendant · 2 generations on · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
Descendant · 3 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
Descendant · 4 generations on · 26 of its ownK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2007high 7 (2019) · low 0 (2010)2026

Most influential descendants

Showing 5 of 58 · See all

K073248Modification to:Mako Surgical Unicondylar Knee SystemMako Surgical Corp. · 2007 · cites it directly57descendants
K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008 · cites it directly56descendants
K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · 2 generations on51descendants
K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · 3 generations on50descendants
K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013 · 4 generations on26descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032824	Stelkast Unicondylar Knee System	Stelkast Company	2003	1
0 (this device)	K060017	Mako Surgical Unicondylar Knee System	Mako Surgical Corp.	2006	—
+1	K073248	Modification to:Mako Surgical Unicondylar Knee System	Mako Surgical Corp.	2007	—
+1	K080368	Mako Surgical Corp. Unicondylar Knee Implant System II	Mako Surgical Corp.	2008	—
+2	K082172	Mako Modular Knee Compartmental Implant System	Mako Surgical Corporation	2008	2
+3	K090763	Restoris Multicompartmental Knee (MCK) System	Mako Surgical Corporation	2009	5
+4	K133039	Restoris Multicompartmental Knee System	Mako Surgical Corporation	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	3	0
2009	1	0
2013	2	0
2014	1	0
2015	2	0
2016	1	0
2017	4	0
2018	2	0
2019	7	0
2020	6	0
2021	5	0
2022	3	0
2023	4	0
2024	5	0
2025	4	0
2026	7	0

FIG. 1 — Lineage of K060017, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HSX? 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 HSX device

#1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K032824	Stelkast Unicondylar Knee System Summary page 1 …prosthesis Substantial Equivalence: The MAKO Su rgical Unicondylar Knee System is substantialIly equ iva lent to Stelkast Corporation's Unicondylar Knee System (K032824). Feature Stelkast Unicondylar Knee System (K032824) I MAKO Surgical Corp.'s…	Stelkast Company	2003	1

Also cleared against K032824: 2 other devices →

What descends from it? (58)

See all 58

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073248	Modification to:Mako Surgical Unicondylar Knee System	Mako Surgical Corp.	2007	57
K080368	Mako Surgical Corp. Unicondylar Knee Implant System II	Mako Surgical Corp.	2008	56

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K073248 (Mako Surgical Corp., 2007) has gone furthest, with 57 descendants of its own.
2 other devices also cite its predicate K032824.

How does its category compare?

All HSX devices

HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSX

4in 2025

2007high 7 (2019) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSX

59in 2025

2007high 160 (2017) · low 33 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSX

2in 2020

2007high 49 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSX

175in 2025

2007high 273 (2020) · low 4 (2008)2025

MAUDE reports naming product code HSX, 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	6	33	0	6
2008	4	102	0	4
2009	2	—	49	21
2010	3	74	0	58
2011	1	—	0	114
2012	5	88	0	83
2013	2	—	1	79
2014	0	—	0	66
2015	1	—	0	57
2016	3	147	1	107
2017	5	160	4	113
2018	2	—	0	159
2019	7	90	0	177
2020	4	40	2	273
2021	7	81	0	240
2022	2	—	0	257
2023	1	—	0	231
2024	4	133	0	172
2025	4	59	0	175
2026	2	—	0	—

What is it indicated for?

The MAKO Surgical Unicondylar Knee is a single use device intended for cemented reconstruction of the medial or lateral femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis provided there is evidence of sufficient bone to seat the implant. Indications for use include moderate joint impairment from painful arthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy in patients with unicompartmental arthritis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060017 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060017: Mako Surgical Unicondylar Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060017

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026