510(k) · Cleared
ClearedMako Shoulder Application (1.0)
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 Nov 7, 2024 as substantially equivalent to K172301 (Mako Surgical Corp., 2017) after a 90-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Nov 7, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K905070 (1991). 43 ancestors in all, the oldest K861692 (1986). No later device cites it as a predicate yet.
- Root · 14 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 10 generations between
- 3 generations backK142530 Partial Knee Application (PKA)Mako Surgical Corporation · 2015
- 2 generations backK170891 Mako Partial Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- 1 generation backK172301 Mako Partial Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- This deviceK242373 Mako Shoulder Application (1.0)Mako Surgical Corp. · 2024
Show all 14 generations
- Root · 14 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 13 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 12 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 11 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 10 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 9 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 8 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 7 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 6 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 5 generations backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 4 generations backK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- 3 generations backK142530 Partial Knee Application (PKA)Mako Surgical Corporation · 2015
- 2 generations backK170891 Mako Partial Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- 1 generation backK172301 Mako Partial Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- This deviceK242373 Mako Shoulder Application (1.0)Mako Surgical Corp. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −13 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −12 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −11 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −10 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −9 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −8 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −7 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −6 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −5 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| −4 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| −3 | K142530 | Partial Knee Application (PKA) | Mako Surgical Corporation | 2015 | — |
| −2 | K170891 | Mako Partial Knee Application | Mako Surgical Corp. | 2017 | 3 |
| −1 | K172301 | Mako Partial Knee Application | Mako Surgical Corp. | 2017 | 6 |
| 0 (this device) | K242373 | Mako Shoulder Application (1.0) | Mako Surgical Corp. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
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 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? (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 | Decided |
|---|---|---|---|
| * | K172301 | Mako Partial Knee ApplicationSummary page 5…quivalence Claimed To: The subject device, the Mako Shoulder Application, is substantially equivalent to the predicate device, Mako Partial Knee Application, cleared via K172301. In addition, the subject device, the Mako Shoulder Application is substantially equivalent to the following reference devices:… | 2017 |
| † | K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | 2022 |
| † | K193128 | Mako Total Hip Application | 2020 |
| † | K233199 | ROSA® Shoulder System | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 12 of the 43 ancestors have a recall of any class.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 | — |
What is it indicated for?
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242373 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242373: Mako Shoulder Application (1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242373
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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