510(k) · Cleared
ClearedVoyager Linux with 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 Nov 18, 2005 as substantially equivalent to K050973 (Mako Surgical Corp., 2005) after a 38-day review. Its family tree reaches back 3 generations to 2000. 96 later devices descend from it.
- Decided
- Nov 18, 2005
- Review
- 38 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000310 (2000). 96 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK000310 Voyager 6.0 Software OptionPhilips Medical Systems (Cleveland), Inc. · 2000
- 2 generations backK023975 Voyager LinuxZ-Kat, Inc. · 2002
- 1 generation backK050973 Modification to: Voyager LinuxMako Surgical Corp. · 2005
- This deviceK052851 Voyager Linux with Tactile Guidance System (TGS)Mako Surgical Corp. · 2005
- Descendant · cites it directly · 78 of its ownK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 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
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 96 · See all- K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · cites it directly78descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000310 | Voyager 6.0 Software Option | Philips Medical Systems (Cleveland), Inc. | 2000 | — |
| −2 | K023975 | Voyager Linux | Z-Kat, Inc. | 2002 | — |
| −1 | K050973 | Modification to: Voyager Linux | Mako Surgical Corp. | 2005 | — |
| 0 (this device) | K052851 | Voyager Linux with Tactile Guidance System (TGS) | Mako Surgical Corp. | 2005 | — |
| +1 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 9 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 0 |
| 2026 | 7 | 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? (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 |
|---|---|---|---|
| * | K050973 | Modification to: Voyager LinuxSummary page 1…on #: 21 CFR 882.4560 Substantial Equivalence Claimed To: Voyager Linux with the Tactile Guidance System (TGS) as described in MAKO Surgical Corp.'s K050973. The modification to add CT capability is shown to be substantially equivalent to the previously cleared system. As required by… | 2005 |
What descends from it? (96)
See all 963 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)
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 5 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K072806 (Mako Surgical Corp., 2008) has gone furthest, with 78 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Voyager/Tactile Guidance System - CT is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures. The Voyager/Tactile Guidance System - CT is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a…
Read the full statement (117 words)
The Voyager/Tactile Guidance System - CT is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The Voyager/Tactile Guidance System - CT is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:
- Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms
- ENT Procedures
- Orthopedic surgical procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052851: Voyager Linux with 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/K052851
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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