510(k) · Cleared
ClearedBrigit Surgical Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jul 31, 2006 as substantially equivalent to K963256 (Integrated Surgical Systems, S.A., 1997) and 5 other predicates after a 151-day review. Its family tree reaches back 3 generations to 2000. 5 of the 141 devices in its family, counting itself, have a Class I recall. 128 later devices descend from it.
- Decided
- Jul 31, 2006
- Review
- 151 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K002053 (2000). 12 ancestors in all, the oldest K811452 (1981). 128 later devices descend from it, 1 citing it directly. 5 of the 141 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 2 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 1 generation backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- This deviceK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- Descendant · cites it directly · 127 of its ownK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- Descendant · 2 generations on · 126 of its ownK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- Descendant · 3 generations on · 109 of its ownK151511 ROSA SpineMedtech S.A · 2016 · Recalled
- Descendant · 4 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 5 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
Showing 5 of 128 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 128 · See all- K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · cites it directly127descendants
- K101791Rosa Surgical DeviceMedtech S.A.S · 2010 · 2 generations on126descendants
- K151511ROSA SpineMedtech S.A · 2016 · 3 generations on109descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 4 generations on69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 5 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −2 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −1 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| 0 (this device) | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| +1 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| +2 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| +3 | K151511 | ROSA Spine | Medtech S.A | 2016 | 3 |
| +4 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +5 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 1 |
| 2019 | 9 | 1 |
| 2020 | 2 | 1 |
| 2021 | 8 | 1 |
| 2022 | 11 | 0 |
| 2023 | 19 | 0 |
| 2024 | 20 | 0 |
| 2025 | 27 | 0 |
| 2026 | 24 | 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.
5 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K963256 | Neuromate Stereotactic SystemSummary page 1…and Reference: Predicate Device: Neuromate Stereotactic system, manufactured by Integrated Surgical Systems, Inc., K963256, cleared May 9, 1997. Navitrack System - S&N Image Free… | 1997 |
| * | K043536 | Navitrack System - S&N Image Free KneeSummary page 1…May 9, 1997. Navitrack System - S&N Image Free Knee, manufactured by Orthosoft, K043536, cleared January 14, 2005. Medtronic Stealth Station, ma… | 2005 |
| * | K050438 | Stealthstation System UpdateSummary page 1…January 14, 2005. Medtronic Stealth Station, manufactured by Medtronic, K050438, cleared June 2, 2005. Zimmer Ortho Guidance Systems - Knee… | 2005 |
| * | K033011 | Zimmer Ortho Guidance Systems- Knee InstrumentsSummary page 1…Zimmer Ortho Guidance Systems - Knee Instruments, manufactured by Zimmer, Inc., K03301 1, cleared February 12, 2004. Zimmer Ortho Guidance Systems - Hip… | 2004 |
| * | K033223 | Zimmer Ortho Guidance Systems- Hip InstrumentsSummary page 1…Zimmer Ortho Guidance Systems - Hip Instruments, manufactured by Zimmer, Inc., K033223, cleared February 18, 2004. Zimmer Computer Assisted Solutions -… | 2004 |
| * | K052425 | Zimmer Computer Assisted Solutions-Electromagnetic and Imageless Knee InstrumentationSummary page 1…Electromagnetic and Imageless Knee Instrumentation, manufactured by Zimmer, Inc., K052425, cleared December 28, 2005. 006 ==… | 2005 |
What descends from it? (128)
See all 1281 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092239 | Rosa Surgical Device, Model Rosa 1.1 | 2009 | 127 |
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K151359ROSA BrainMedtech S.A · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K092239 (Medtech S.A, 2009) has gone furthest, with 127 descendants of its own.
- 2 other devices also cite its predicate K963256.
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?
BRIGIT Surgical Device is a computer controlled electromechanical multi-jointed arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide to be used by the surgeon to manually guide orthopedic instruments. It is indicated for any orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a…
Read the full statement (144 words)
BRIGIT Surgical Device is a computer controlled electromechanical multi-jointed arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide to be used by the surgeon to manually guide orthopedic instruments.
It is indicated for any orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to digitized landmarks of the anatomy.
Example orthopedic procedures for these instruments include, but are not limited to:
* Total Knee Arthroplasty (Primary and Revision)
* Unicompartmental Knee Arthroplasty (Primary and Revision)
* Minimally Invasive Knee Orthopedic Procedures
• Total or Hemi-Hip Arthroplasty (Primary and Revision)
* Minimally Invasive Hip Orthopedic Procedures
* Tumor Resection and Bone/Joint Reconstruction
• Stabilization or Repair of Pelvic/Femoral Fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060556 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060556: Brigit Surgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060556
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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