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 Micofixation · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Aug 23, 2022 as substantially equivalent to K062842 (Walter Lorenz Surgical, Inc., 2006) after a 334-day review. Its family tree reaches back 3 generations to 1983. 1 later device descends from it.
- Decided
- Aug 23, 2022
- Review
- 334 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K832187 (1983). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK832187 Hall OscillatorAmsco Co. · 1983
- 2 generations backK032607 Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185Linvatec Corp. · 2003
- 1 generation backK062842 Twist DrillWalter Lorenz Surgical, Inc. · 2006 · Recalled
- This deviceK213072 2.1 x 255mm Drill, 22mm StopBiomet Micofixation · 2022
- Descendant · cites it directly · 0 of its ownK223199 2.1 x 255mm Drill, 22mm StopBiomet Microfixation · 2022
Most influential descendants
Showing 1 of 1 · See all- K2231992.1 x 255mm Drill, 22mm StopBiomet Microfixation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K832187 | Hall Oscillator | Amsco Co. | 1983 | — |
| −2 | K032607 | Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185 | Linvatec Corp. | 2003 | — |
| −1 | K062842 | Twist Drill | Walter Lorenz Surgical, Inc. | 2006 | 1 |
| 0 (this device) | K213072 | 2.1 x 255mm Drill, 22mm Stop | Biomet Micofixation | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 13.2 · 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 |
|---|---|---|---|
| * | K062842 | Twist DrillSummary page 5…rocedures. Substantial Equivalence: The subject device is substantially equivalent to the following predicate device: Walter Lorenz Surgical, Inc; Lorenz Twist Drills – K062842 The subject and predicate devices are similar in Intended Use, Technological Characteristics, and Material. Characteristic… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223199 | 2.1 x 255mm Drill, 22mm Stop | 2022 | 0 |
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 4 companies; a new generation was cleared every 15.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K223199 (Biomet Microfixation, 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K062842.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213072: 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/K213072
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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