510(k) · Cleared
ClearedMako Surgical Tactile Guidance System-Hip
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 Jun 19, 2009 as substantially equivalent to K072806 (Mako Surgical Corp., 2008) and 5 other predicates after a 192-day review. Its family tree reaches back 8 generations to 1991. 13 later devices descend from it.
- Decided
- Jun 19, 2009
- Review
- 192 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K905070 (1991). 42 ancestors in all, the oldest K861692 (1986). 13 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 7 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 6 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 5 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 4 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 3 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 2 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 1 generation backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- This deviceK083644 Mako Surgical Tactile Guidance System-HipMako Surgical Corp. · 2009
- Descendant · cites it directly · 12 of its ownK091998 Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009
- Descendant · 2 generations on · 11 of its ownK093425 Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · Recalled
- Descendant · 3 generations on · 9 of its ownK121064 Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- Descendant · 4 generations on · 8 of its ownK141989 Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014 · Recalled
- Descendant · 5 generations on · 7 of its ownK170593 Mako Total Hip ApplicationMako Surgical Corp. · 2017 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009 · cites it directly12descendants
- K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · 2 generations on11descendants
- K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · 3 generations on9descendants
- K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014 · 4 generations on8descendants
- K170593Mako Total Hip ApplicationMako Surgical Corp. · 2017 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −7 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −6 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −5 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −4 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −3 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −2 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −1 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| 0 (this device) | K083644 | Mako Surgical Tactile Guidance System-Hip | Mako Surgical Corp. | 2009 | — |
| +1 | K091998 | Robotic Arm Interactive Orthopedic System-Hip | Mako Surgical Corp. | 2009 | — |
| +2 | K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha | Mako Surgical Corp. | 2010 | 2 |
| +3 | 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 |
| +5 | K170593 | Mako Total Hip Application | Mako Surgical Corp. | 2017 | 1 |
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 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K072806 | Mako Surgical Tactile Guidance System (TGS)Summary page 1…Product Code: HAW Substantial Equivalence Claimed To: The TGS - Hip is substantially equivalent to MAKO Surgical's Tactile Guidance System (K072806), Brainlab's Vectorvision Hip (KO1 0602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K02… | 2008 |
| * | K010602 | Vectorvision Hip | 2001 |
| * | K040368 | Vectorvision Hip 3.0Summary page 1…ubstantial Equivalence Claimed To: The TGS - Hip is substantially equivalent to MAKO Surgical's Tactile Guidance System (K072806), Brainlab's Vectorvision Hip (KO1 0602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364). Description: The TGS - Hip is a stereotax… | 2004 |
| * | K052213 | Navigation SW Hip 3.1 on CISummary page 1…l Equivalence Claimed To: The TGS - Hip is substantially equivalent to MAKO Surgical's Tactile Guidance System (K072806), Brainlab's Vectorvision Hip (KO1 0602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364). Description: The TGS - Hip is a stereotaxic instru… | 2005 |
| * | K072716 | Vector Vision HipSummary page 1…ence Claimed To: The TGS - Hip is substantially equivalent to MAKO Surgical's Tactile Guidance System (K072806), Brainlab's Vectorvision Hip (KO1 0602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364). Description: The TGS - Hip is a stereotaxic instrument that… | 2007 |
| * | K022364 | Navitrack System Total Hip Replacement,Model 900.200Summary page 1…Surgical's Tactile Guidance System (K072806), Brainlab's Vectorvision Hip (KO1 0602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364). Description: The TGS - Hip is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation,… | 2003 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091998 | Robotic Arm Interactive Orthopedic System-Hip | 2009 | 12 |
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 18 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 42 ancestors have a recall of any class.
- Of its descendants, K091998 (Mako Surgical Corp., 2009) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K072806.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Tactile Guidance System - Hip is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Tactile Guidance System - Hip is indicated for use in surgical hip 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. These procedures include:
Acetabular reaming during total hip arthoplasty (THA)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083644: Mako Surgical Tactile Guidance System-Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083644
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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