510(k) · Cleared
Recalled · Class II · 2012Mako Surgical Tactile Guidance System Version 2.0
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 Nov 25, 2008 as substantially equivalent to K072806 (Mako Surgical Corp., 2008) and 3 other predicates after a 147-day review. Its family tree reaches back 8 generations to 1991. 76 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 25, 2008
- Review
- 147 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 8 generations to K905070 (1991). 37 ancestors in all, the oldest K861692 (1986). 76 later devices descend from it, 5 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 deviceK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008
- Descendant · cites it directly · 46 of its ownK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- Descendant · 2 generations on · 44 of its ownK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- Descendant · 3 generations on · 38 of its ownK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- Descendant · 4 generations on · 37 of its ownK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- Descendant · 5 generations on · 29 of its ownK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · cites it directly46descendants
- K143752Total Knee Application (TKA)Mako Surgical Corp. · 2015 · 2 generations on44descendants
- K170581Mako Total Knee ApplicationMako Surgical Corp. · 2017 · 3 generations on38descendants
- K172219Mako Total Knee ApplicationMako Surgical Corp. · 2017 · 4 generations on37descendants
- K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019 · 5 generations on29descendants
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) | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | — |
| +1 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| +2 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| +3 | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 1 |
| +4 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | — |
| +5 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
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 |
|---|---|---|
| 2009 | 1 | 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? (4)
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…21 CFR 882.4560 Substantial Equivalence Claimed To: The Tactile Guidance System (TGS) v2.0 is substantially equivalent to the MAKO Surgical's Tactile Guidance System (K072806) and Voyager/Tactile Guidance System-CT (K052851) and Biomet's Acumen Tm Surgical Navigation System (K031454 and K031337). Descri… | 2008 |
| * | K052851 | Voyager Linux with Tactile Guidance System (TGS)Summary page 1…d To: The Tactile Guidance System (TGS) v2.0 is substantially equivalent to the MAKO Surgical's Tactile Guidance System (K072806) and Voyager/Tactile Guidance System-CT (K052851) and Biomet's Acumen Tm Surgical Navigation System (K031454 and K031337). Description: The TGS v2.0 is a stereotaxic instrument t… | 2005 |
| * | K031454 | Acumen Surgical Navigation SystemSummary page 1…y equivalent to the MAKO Surgical's Tactile Guidance System (K072806) and Voyager/Tactile Guidance System-CT (K052851) and Biomet's Acumen Tm Surgical Navigation System (K031454 and K031337). Description: The TGS v2.0 is a stereotaxic instrument that includes an optical detector, computer, dedicated instru… | 2004 |
| * | K031337 | Acumen Surgical Navigation SystemSummary page 1…to the MAKO Surgical's Tactile Guidance System (K072806) and Voyager/Tactile Guidance System-CT (K052851) and Biomet's Acumen Tm Surgical Navigation System (K031454 and K031337). Description: The TGS v2.0 is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation, o… | 2003 |
What descends from it? (76)
See all 765 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 |
|---|---|---|---|---|
| Sep 12, 2012 | Class II | Z-0385-2013 | Software design | MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining… |
| Jul 17, 2009 | Not classified | Z-0064-2010 | Device Design | Cables fail to provide adequate transmission. MAKO Surgical Corporation is recalling 200996 Cable Assembly, Hybrid Extended Length; 200997 Cable Assembly, Hybrid, Guidance Module; and 200998 Cable Assembly, Hybrid, UI Panel. These parts… |
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.
- 7 of the 37 ancestors have a recall of any class.
- Of its descendants, K112507 (Mako Surgical Corporation, 2012) has gone furthest, with 46 descendants of its own.
- 1 other device also cites its predicate K072806.
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 v2.0 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 v2.0 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 and/or patellofemoral knee replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081867: Mako Surgical Tactile Guidance System Version 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081867
Report an extraction error
Are you the manufacturer?
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