510(k) · Cleared
Recalled · 2009Twist Drill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Dec 4, 2006 as substantially equivalent to K032607 (Linvatec Corp., 2003) and 1 other predicate after a 73-day review. Its family tree reaches back 2 generations to 1983. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 4, 2006
- Review
- 73 days
- Class
- Class II
- Product code
- HBE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K832187 (1983). 4 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK832187 Hall OscillatorAmsco Co. · 1983
- 1 generation backK032607 Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185Linvatec Corp. · 2003
- This deviceK062842 Twist DrillWalter Lorenz Surgical, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK213072 2.1 x 255mm Drill, 22mm StopBiomet Micofixation · 2022
- Descendant · 2 generations on · 0 of its ownK223199 2.1 x 255mm Drill, 22mm StopBiomet Microfixation · 2022
- Descendant · cites it directly · 0 of its ownK213208 Twist DrillsBiomet Microfixation · 2021
- Descendant · cites it directly · 0 of its ownK170442 Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK070876 Stryker Twist DrillsStryker Craniomaxillofacial · 2007
Most influential descendants
Showing 5 of 5 · See all- K2130722.1 x 255mm Drill, 22mm StopBiomet Micofixation · 2022 · cites it directly1descendant
- K2231992.1 x 255mm Drill, 22mm StopBiomet Microfixation · 2022 · 2 generations on0descendants
- K213208Twist DrillsBiomet Microfixation · 2021 · cites it directly0descendants
- K170442Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation · 2017 · cites it directly0descendants
- K070876Stryker Twist DrillsStryker Craniomaxillofacial · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K832187 | Hall Oscillator | Amsco Co. | 1983 | — |
| −1 | K032607 | Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185 | Linvatec Corp. | 2003 | — |
| 0 (this device) | K062842 | Twist Drill | Walter Lorenz Surgical, Inc. | 2006 | — |
| +1 | K213072 | 2.1 x 255mm Drill, 22mm Stop | Biomet Micofixation | 2022 | — |
| +2 | K223199 | 2.1 x 255mm Drill, 22mm Stop | Biomet Microfixation | 2022 | — |
| +1 | K213208 | Twist Drills | Biomet Microfixation | 2021 | — |
| +1 | K170442 | Cranial Drill Bits and Accessories | Ad-Tech Medical Instrument Corporation | 2017 | 2 |
| +1 | K070876 | Stryker Twist Drills | Stryker Craniomaxillofacial | 2007 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K032607 | Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185Summary page 1…t to the existing Twist drills which are cla~ssified as class I devices. W. Lorenz twist drills are also equivalent to Linvatec PowerPro Pneumatic System K032607 and Stryker Oral Max System K954690. DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2003 |
| * | K954690 | Stryker Oral Max SystemSummary page 1…are cla~ssified as class I devices. W. Lorenz twist drills are also equivalent to Linvatec PowerPro Pneumatic System K032607 and Stryker Oral Max System K954690. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1996 |
| * | — | existing Twist drills Named without a submission number |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2009 | Not classified | Z-0538-2010 | Process change control | The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 20.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K213072 (Biomet Micofixation, 2022) has gone furthest, with 1 descendant of its own.
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.
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 large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062842 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062842: Twist Drill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062842
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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