# K162544: OsteoMed PINNACLE Driver

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed
- Decided: Apr 4, 2017 after 204 days
- Product code: KMW (Handpiece, Rotary Bone Cutting)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933101 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933101: The Osteomed B Power System and Accessories, Osteomed Corp. (1994) Summary page 4.

## Indications for use
The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with dental, orthognathic, and mandibular surgical procedures.

Source page: https://510kreport.com/device/K162544
Methodology: https://510kreport.com/methodology