# K070876: Stryker Twist Drills

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Craniomaxillofacial
- Decided: Apr 27, 2007 after 29 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). 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)
- K943541: 75K Staight Drill, Stryker Corp. (1995) Summary page 1.
- K954690: Stryker Oral Max System, Stryker Corp. (1996) Summary page 1.
- K062842: Twist Drill, Walter Lorenz Surgical, Inc. (2006) Summary page 1.
- (no number) existing Twist drills: named in the summary without a submission number

## Indications for use
The Stryker® 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/K070876
Methodology: https://510kreport.com/methodology