# K964073: Bme Bone Drill Bits

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Ent., Inc.
- Decided: Nov 14, 1996 after 34 days
- Product code: GEY (Motor, Surgical Instrument, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K071732: Marrowminer (2007), 4 descendants of its own
- K152474: Avitus Bone Harvester (2015), 3 descendants of its own
- K170539: Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm (2017), 2 descendants of its own
- K210631: Avitus (r) Bone Harvester (2021), 1 descendant of its own
- K243407: Forcyte Autograft Harvest Kit (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K964073
Methodology: https://510kreport.com/methodology