# K223199: 2.1 x 255mm Drill, 22mm Stop

- Pathway: 510(k) (Special)
- Applicant: Biomet Microfixation
- Decided: Nov 15, 2022 after 33 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K832187 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213072: 2.1 x 255mm Drill, 22mm Stop, Biomet Micofixation (2022) Summary page 4.

## Indications for use
The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.

Source page: https://510kreport.com/device/K223199
Methodology: https://510kreport.com/methodology