510(k) · Cleared
Cleared2.1 x 255mm Drill, 22mm Stop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Microfixation · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Nov 15, 2022 as substantially equivalent to K213072 (Biomet Micofixation, 2022) after a 33-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Nov 15, 2022
- Review
- 33 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K832187 (1983). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK832187 Hall OscillatorAmsco Co. · 1983
- 3 generations backK032607 Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185Linvatec Corp. · 2003
- 2 generations backK062842 Twist DrillWalter Lorenz Surgical, Inc. · 2006 · Recalled
- 1 generation backK213072 2.1 x 255mm Drill, 22mm StopBiomet Micofixation · 2022
- This deviceK223199 2.1 x 255mm Drill, 22mm StopBiomet Microfixation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K832187 | Hall Oscillator | Amsco Co. | 1983 | — |
| −3 | K032607 | Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185 | Linvatec Corp. | 2003 | — |
| −2 | K062842 | Twist Drill | Walter Lorenz Surgical, Inc. | 2006 | 1 |
| −1 | K213072 | 2.1 x 255mm Drill, 22mm Stop | Biomet Micofixation | 2022 | — |
| 0 (this device) | K223199 | 2.1 x 255mm Drill, 22mm Stop | Biomet Microfixation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 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 HBE? 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 HBE device
- #1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.1 · 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? (1)
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 |
|---|---|---|---|
| * | K213072 | 2.1 x 255mm Drill, 22mm StopSummary page 4…Phone: (901) 827-8670 510(k) Number: K223199 Trade Name: 2.1 x 255mm Drill, 22mm Stop Predicate Device: K213072 - 2.1 x 255mm Drill, 22mm Stop Common Name: Drills, Burrs, Trephines & Accessories (Simple, Powered) Classific… | 2022 |
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 39 years and passes through 5 companies; a new generation was cleared every 15.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
How does its category compare?
All HBE devicesHBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HBE
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBE
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBE
1,924in 2025
MAUDE reports naming product code HBE, 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 | 2 | — | 0 | 14 |
| 2008 | 2 | — | 47 | 14 |
| 2009 | 0 | — | 7 | 242 |
| 2010 | 0 | — | 23 | 492 |
| 2011 | 2 | — | 1 | 1,013 |
| 2012 | 1 | — | 26 | 1,146 |
| 2013 | 1 | — | 4 | 1,583 |
| 2014 | 2 | — | 0 | 559 |
| 2015 | 3 | 155 | 0 | 483 |
| 2016 | 2 | — | 7 | 848 |
| 2017 | 2 | — | 3 | 848 |
| 2018 | 2 | — | 0 | 787 |
| 2019 | 5 | 133 | 0 | 836 |
| 2020 | 0 | — | 0 | 1,025 |
| 2021 | 6 | 193 | 1 | 1,047 |
| 2022 | 2 | — | 0 | 900 |
| 2023 | 2 | — | 3 | 948 |
| 2024 | 0 | — | 1 | 1,153 |
| 2025 | 6 | 30 | 0 | 1,924 |
| 2026 | 1 | — | 19 | — |
What is it indicated for?
The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223199: 2.1 x 255mm Drill, 22mm Stop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223199
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