510(k) · Cleared
ClearedMako Total Hip Application 5.0
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 Mar 5, 2025 as substantially equivalent to K193128 (Mako Surgical Corp., 2020) after a 90-day review. Its family tree reaches back 16 generations to 1991. 1 later device descends from it.
- Decided
- Mar 5, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K905070 (1991). 58 ancestors in all, the oldest K861692 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 16 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 12 generations between
- 3 generations backK170593 Mako Total Hip ApplicationMako Surgical Corp. · 2017 · Recalled
- 2 generations backK191998 Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019
- 1 generation backK193128 Mako Total Hip ApplicationMako Surgical Corp. · 2020
- This deviceK243751 Mako Total Hip Application 5.0Mako Surgical Corp. · 2025
- Descendant · cites it directly · 0 of its ownK252847 NextAR Hip PlatformMedacta International S.A. · 2026
Show all 16 generations
- Root · 16 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 15 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 14 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 13 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 12 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 11 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 10 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 9 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 8 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 7 generations backK091998 Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009
- 6 generations backK093425 Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · Recalled
- 5 generations backK121064 Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 4 generations backK141989 Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014 · Recalled
- 3 generations backK170593 Mako Total Hip ApplicationMako Surgical Corp. · 2017 · Recalled
- 2 generations backK191998 Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019
- 1 generation backK193128 Mako Total Hip ApplicationMako Surgical Corp. · 2020
- This deviceK243751 Mako Total Hip Application 5.0Mako Surgical Corp. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252847NextAR Hip PlatformMedacta International S.A. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −15 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −14 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −13 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −12 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −11 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −10 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −9 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −8 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −7 | K091998 | Robotic Arm Interactive Orthopedic System-Hip | Mako Surgical Corp. | 2009 | — |
| −6 | K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha | Mako Surgical Corp. | 2010 | 2 |
| −5 | K121064 | Makoplasty Total Hip Application, Rio Standard System | Mako Surgical Corporation | 2012 | 12 |
| −4 | K141989 | Makoplasty Total Hip Allpication, Rio Standard System | Mako Surgical Corporation | 2014 | 3 |
| −3 | K170593 | Mako Total Hip Application | Mako Surgical Corp. | 2017 | 1 |
| −2 | K191998 | Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. | 2019 | — |
| −1 | K193128 | Mako Total Hip Application | Mako Surgical Corp. | 2020 | — |
| 0 (this device) | K243751 | Mako Total Hip Application 5.0 | Mako Surgical Corp. | 2025 | — |
| +1 | K252847 | NextAR Hip Platform | Medacta International S.A. | 2026 | — |
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 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K193128 | Mako Total Hip ApplicationSummary page 5…Equivalence Claimed To: The subject device, the Mako Total Hip Application, is substantially equivalent to the predicate device, Mako Total Hip Application, cleared via K193128. Device Modifications: The following changes have been made to the Mako Total Hip Application: Indications For Use: A revision… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252847 | NextAR Hip Platform | 2026 | 0 |
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 34 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 17 of the 58 ancestors have a recall of any class.
- Of its descendants, K252847 (Medacta International S.A., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K193128.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 total hip arthroplasty 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…
Read the full statement (112 words)
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 total hip arthroplasty 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;
including revision total hip arthroplasty procedures where:
• the primary acetabular component is well-fixed to the pelvic anatomy, and
• the acetabular component can be revised with either a cup or cup and wedge augment construct.
These procedures include: Total Hip Arthroplasty (THA)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243751: Mako Total Hip Application 5.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243751
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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