510(k) · Cleared
ClearedThe Bioplate Battery Powered Drill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioplate, Inc. · HBC Motor, Drill, Electric
Cleared on Nov 19, 2002 as substantially equivalent to K012457 (Sodemsystems, 2001) and 5 other predicates after a 71-day review. Its family tree reaches back 6 generations to 1986.
- Decided
- Nov 19, 2002
- Review
- 71 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K862807 (1986). 23 ancestors in all, the oldest K852143 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 5 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 4 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 3 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 2 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 1 generation backK012457 Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001
- This deviceK022986 The Bioplate Battery Powered DrillBioplate, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −5 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −4 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −3 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −2 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −1 | K012457 | Sodem High Speed System (Electric) (Neuro/Spine Surgery) | Sodemsystems | 2001 | — |
| 0 (this device) | K022986 | The Bioplate Battery Powered Drill | Bioplate, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HBC device
- #1 K254174 Surgical Power Systemscore 14.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012457 | Sodem High Speed System (Electric) (Neuro/Spine Surgery) | 2001 |
| * | K012453 | Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) | 2001 |
| * | K011444 | Anspach Emax Drill System | 2001 |
| * | K003612 | Microspeed EC Motorsystem GD650/GD653 | 2001 |
| * | K002523 | Advantage Drive System | 2000 |
| * | K972857 | Servotronic EC100 SystemSummary page 2…Microspeed EC Motorsystem KO03612 Linvatec Corporation AdvantageTMDrive System KO02523 Medicon, E.G. Servotronic ECI 00 System K972857 Description of the device The BioplateB Battery Powered Drill is comprised of a metal housing, containing the motor, designed… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 23 ancestors have a recall of any class.
- 3 other devices also cite its predicate K012457.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBC
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HBC
Too few HBC 510(k)s in any year since 2007 to give a median.
Recalls per year · HBC
9in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBC
635in 2025
MAUDE reports naming product code HBC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 9 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 10,670 |
| 2014 | 1 | — | 1 | 2,643 |
| 2015 | 0 | — | 0 | 1,953 |
| 2016 | 1 | — | 0 | 2,541 |
| 2017 | 2 | — | 0 | 2,079 |
| 2018 | 1 | — | 0 | 1,779 |
| 2019 | 1 | — | 0 | 1,703 |
| 2020 | 0 | — | 0 | 1,304 |
| 2021 | 1 | — | 0 | 946 |
| 2022 | 2 | — | 9 | 760 |
| 2023 | 0 | — | 0 | 663 |
| 2024 | 2 | — | 0 | 427 |
| 2025 | 0 | — | 0 | 635 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022986: The Bioplate Battery Powered Drill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022986
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026