# K022986: The Bioplate Battery Powered Drill

- Pathway: 510(k) (Traditional)
- Applicant: Bioplate, Inc.
- Decided: Nov 19, 2002 after 71 days
- Product code: HBC (Motor, Drill, Electric)
- Device class: 2
- Regulation: 21 CFR 882.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K862807 (1986). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012457: Sodem High Speed System (Electric) (Neuro/Spine Surgery), Sodemsystems (2001)
- K012453: Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery), Sodemsystems (2001)
- K011444: Anspach Emax Drill System, The Anspach Effort, Inc. (2001)
- K003612: Microspeed EC Motorsystem GD650/GD653, Aesculap, Inc. (2001)
- K002523: Advantage Drive System, Linvatec Corp. (2000)
- K972857: Servotronic EC100 System, Medicon EG (1998) Summary page 2.

## Indications for use
The BioplateB Battery Powered Drill is intended to be used to drill pilot holes to facilitate the insertion of self-tapping bone screws in surgical procedures on a patient's skull. The BioplateB Battery Powered Drill is not intended for bone cutting or bone shaping indications.

Source page: https://510kreport.com/device/K022986
Methodology: https://510kreport.com/methodology