# K213208: Twist Drills

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Microfixation
- Decided: Dec 23, 2021 after 85 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: 3 generations back to K832187 (1983). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062842: Twist Drill, Walter Lorenz Surgical, Inc. (2006) Summary page 4.

## Indications for use
Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Source page: https://510kreport.com/device/K213208
Methodology: https://510kreport.com/methodology