# K153519: DReal

- Pathway: 510(k) (Traditional)
- Applicant: Carevature Medical, Ltd.
- Decided: Mar 16, 2016 after 99 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: 2 generations back to K112593 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143540: Stryker MIS Attachments and Cutting Accessories, Stryker Corporation (2015) Summary page 4.

## Indications for use
The Carevature DReal™ is intended to be used with high-speed compatible electric and pneumatic motors. When used with these motors, it is intended to cut bone by drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for neurosurgical and spinal applications. Specific applications include laminectomy/laminotomy and craniotomy/craniectomy/ skull base cuts < 1cm3.

Source page: https://510kreport.com/device/K153519
Methodology: https://510kreport.com/methodology