510(k) · Cleared
ClearedBall Joint Guide Array (66295)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Medical Care, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Sep 4, 2025 as substantially equivalent to K180854 (Voyager Therapeutics, Inc., 2018) after a 163-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Sep 4, 2025
- Review
- 163 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K992304 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK992304 Navigus Trajectory Guide, Model TG-XXXXImage-Guided Neurologics, Inc. · 1999
- 2 generations backK090240 Monteris Medical UfoMonteris Medical, · 2009
- 1 generation backK180854 Voyager Trajectory Array Guide (V-TAG)Voyager Therapeutics, Inc. · 2018
- This deviceK250893 Ball Joint Guide Array (66295)Bayer Medical Care, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K992304 | Navigus Trajectory Guide, Model TG-XXXX | Image-Guided Neurologics, Inc. | 1999 | — |
| −2 | K090240 | Monteris Medical Ufo | Monteris Medical, | 2009 | — |
| −1 | K180854 | Voyager Trajectory Array Guide (V-TAG) | Voyager Therapeutics, Inc. | 2018 | — |
| 0 (this device) | K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180854 | Voyager Trajectory Array Guide (V-TAG)Summary page 5…Regulatory Class: II Product Code: HAW - Neurological Stereotaxic Instrument 3. PREDICATE DEVICE Voyager Trajectory Array Guide (V-TAG, K180854). This predicate is a Class II device regulated under 21 CFR 882.4560 - Stereotaxic instrument This predicate has not been… | 2018 |
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 26 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K180854.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Ball Joint Guide Array (BJGA) is intended to assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and perioperative MR imaging. These procedures include laser coagulation, biopsies, catheter placement, and electrode placement procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250893: Ball Joint Guide Array (66295).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250893
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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