510(k) · Cleared
Recalled · 2008Mako Surgical Tactile Guidance System (TGS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mako Surgical Corp. · HAW Neurological Stereotaxic Instrument
Cleared on Jan 24, 2008 as substantially equivalent to K052851 (Mako Surgical Corp., 2005) and 5 other predicates after a 115-day review. Its family tree reaches back 7 generations to 1991. 78 later devices descend from it. It has been recalled once.
- Decided
- Jan 24, 2008
- Review
- 115 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 7 generations to K905070 (1991). 36 ancestors in all, the oldest K861692 (1986). 78 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 6 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 5 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 4 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 3 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 2 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 1 generation backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- This deviceK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008
- Descendant · cites it directly · 76 of its ownK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- Descendant · 2 generations on · 46 of its ownK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- Descendant · 3 generations on · 44 of its ownK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- Descendant · 4 generations on · 38 of its ownK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- Descendant · 5 generations on · 37 of its ownK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · cites it directly76descendants
- K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · 2 generations on46descendants
- K143752Total Knee Application (TKA)Mako Surgical Corp. · 2015 · 3 generations on44descendants
- K170581Mako Total Knee ApplicationMako Surgical Corp. · 2017 · 4 generations on38descendants
- K172219Mako Total Knee ApplicationMako Surgical Corp. · 2017 · 5 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −6 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −5 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −4 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −3 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −2 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −1 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| 0 (this device) | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | — |
| +1 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| +2 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| +3 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| +4 | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 1 |
| +5 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 9 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K052851 | Voyager Linux with Tactile Guidance System (TGS)Summary page 1…II Classification #: 21 CFR 882.4560 Substantial Equivalence Claimed To: The TGS is substantially equivalent to the Voyager! Tactile Guidance System - CT (K052851), Uni-Knee Surgetics Navigation System (K062146), Acumen System (K031454, K031337), Vectorvision Uni-Knee (K041 899), and Navitra… | 2005 |
| * | K062146 | Uni Knee Surgetics Navigation SystemSummary page 1…560 Substantial Equivalence Claimed To: The TGS is substantially equivalent to the Voyager! Tactile Guidance System - CT (K052851), Uni-Knee Surgetics Navigation System (K062146), Acumen System (K031454, K031337), Vectorvision Uni-Knee (K041 899), and Navitrack System-OS Unicondylar Knee Universal (K071714… | 2006 |
| * | K031454 | Acumen Surgical Navigation SystemSummary page 1…ce Claimed To: The TGS is substantially equivalent to the Voyager! Tactile Guidance System - CT (K052851), Uni-Knee Surgetics Navigation System (K062146), Acumen System (K031454, K031337), Vectorvision Uni-Knee (K041 899), and Navitrack System-OS Unicondylar Knee Universal (K071714). Description: The TGS i… | 2004 |
| * | K031337 | Acumen Surgical Navigation SystemSummary page 1…d To: The TGS is substantially equivalent to the Voyager! Tactile Guidance System - CT (K052851), Uni-Knee Surgetics Navigation System (K062146), Acumen System (K031454, K031337), Vectorvision Uni-Knee (K041 899), and Navitrack System-OS Unicondylar Knee Universal (K071714). Description: The TGS is a stere… | 2003 |
| * | K041899 | Vectorvision Uni-KneeSummary page 1…uivalent to the Voyager! Tactile Guidance System - CT (K052851), Uni-Knee Surgetics Navigation System (K062146), Acumen System (K031454, K031337), Vectorvision Uni-Knee (K041 899), and Navitrack System-OS Unicondylar Knee Universal (K071714). Description: The TGS is a stereotaxic instrument that includes an… | 2004 |
| * | K071714 | Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Summary page 1…, Uni-Knee Surgetics Navigation System (K062146), Acumen System (K031454, K031337), Vectorvision Uni-Knee (K041 899), and Navitrack System-OS Unicondylar Knee Universal (K071714). Description: The TGS is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation, operat… | 2007 |
What descends from it? (78)
See all 782 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 2, 2008 | Not classified | Z-0915-2009 | Component design/selection | The product in its current state may fail during use, which would cause the instrument to be in-accurate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 36 ancestors have a recall of any class.
- Of its descendants, K081867 (Mako Surgical Corp., 2008) has gone furthest, with 76 descendants of its own.
- 2 other devices also cite its predicate K052851.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The Tactile Guidance 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 Tactile Guidance System is indicated for use in surgical knee 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:
· Unicondylar knee replacement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072806: Mako Surgical Tactile Guidance System (TGS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072806
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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