# K250893: Ball Joint Guide Array (66295)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Medical Care, Inc.
- Decided: Sep 4, 2025 after 163 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K992304 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180854: Voyager Trajectory Array Guide (V-TAG), Voyager Therapeutics, Inc. (2018) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K250893
Methodology: https://510kreport.com/methodology