510(k) · Cleared
ClearedBone Anchor (NGS-BA-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ClearPoint Neuro, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Apr 26, 2024 as substantially equivalent to K132611 (Fred Haer Company, Inc., 2014) after a 161-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Apr 26, 2024
- Review
- 161 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K854886 (1986). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK854886 Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. · 1986 · Recalled
- 3 generations backK961120 Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc. · 1996
- 2 generations backK092192 Waypoint Stereotactic SystemFHC, Inc. · 2010
- 1 generation backK132611 Microtable SystemFred Haer Company, Inc. · 2014
- This deviceK233703 Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K854886 | Wuerzburg Titanium Mini Bone Plates & Bone Screws | Walter Lorenz Surgical, Inc. | 1986 | 1 |
| −3 | K961120 | Marker System for Stereotaxic Navigation | Howmedica Leibinger, Inc. | 1996 | — |
| −2 | K092192 | Waypoint Stereotactic System | FHC, Inc. | 2010 | — |
| −1 | K132611 | Microtable System | Fred Haer Company, Inc. | 2014 | — |
| 0 (this device) | K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 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 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.
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 5 companies; a new generation was cleared every 10.3 years on median.
- 3 of the 10 ancestors have a recall of any class.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Bone Anchor is intended to be used with commercially available stereotactic systems for
intracranial and neurosurgical procedures which require accurate positioning of compatible small
surgical instruments or accessories in the cranium, brain, or nervous systems. It is designed to
provide short-term fixation and positioning of compatible neurosurgical instruments or accessories
under image-guidance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233703: Bone Anchor (NGS-BA-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233703
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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