# K062842: Twist Drill

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Dec 4, 2006 after 73 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K832187 (1983). 4 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032607: Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185, Linvatec Corp. (2003) Summary page 1.
- K954690: Stryker Oral Max System, Stryker Corp. (1996) Summary page 1.
- (no number) existing Twist drills: named in the summary without a submission number

## Most influential descendants
- K213072: 2.1 x 255mm Drill, 22mm Stop (2022), 1 descendant of its own
- K223199: 2.1 x 255mm Drill, 22mm Stop (2022), 0 descendants of its own
- K213208: Twist Drills (2021), 0 descendants of its own
- K170442: Cranial Drill Bits and Accessories (2017), 0 descendants of its own
- K070876: Stryker Twist Drills (2007), 0 descendants of its own

## Recalls of this device
- Nov 6, 2009 · Not classified · Z-0538-2010: The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU).

## Indications for use
The Lorenz Twist Drills are intended to be used 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/K062842
Methodology: https://510kreport.com/methodology