510(k) · Cleared
ClearedLorenz Fiducail Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Mar 15, 2001 as substantially equivalent to K961120 (Howmedica Leibinger, Inc., 1996) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- Mar 15, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K854886 (1986). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK854886 Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. · 1986 · Recalled
- 1 generation backK961120 Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc. · 1996
- This deviceK010427 Lorenz Fiducail ScrewWalter Lorenz Surgical, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK160385 Precision ScrewCryptych Pty, Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K160385Precision ScrewCryptych Pty, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854886 | Wuerzburg Titanium Mini Bone Plates & Bone Screws | Walter Lorenz Surgical, Inc. | 1986 | 1 |
| −1 | K961120 | Marker System for Stereotaxic Navigation | Howmedica Leibinger, Inc. | 1996 | — |
| 0 (this device) | K010427 | Lorenz Fiducail Screw | Walter Lorenz Surgical, Inc. | 2001 | — |
| +1 | K160385 | Precision Screw | Cryptych Pty, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K961120 | Marker System for Stereotaxic NavigationSummary page 1…stantial Equivalence: Walter Lorenz considers the Lorenz Fiducial Screw equivalent to the Howmedica Leibinger, Inc. Ost-Reg Marker System for Stereotaxic Navigation, K961120 and Lorenz 1.Omm, 1.5mm, 2.Omm systems, K953385. TAB 3 includes a substantial equivalence comparison table to competitive devices… | 1996 |
| * | K953385 | Lorenz 1.0MM, 1.5MM, 2.0MM SystemSummary page 1…s the Lorenz Fiducial Screw equivalent to the Howmedica Leibinger, Inc. Ost-Reg Marker System for Stereotaxic Navigation, K961120 and Lorenz 1.Omm, 1.5mm, 2.Omm systems, K953385. TAB 3 includes a substantial equivalence comparison table to competitive devices. TAB 4 includes information for Howmedica Leibi… | 1995 |
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 |
|---|---|---|---|
| K160385 | Precision Screw | 2016 | 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 15 years and passes through 2 companies; a new generation was cleared every 10.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K160385 (Cryptych Pty, Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K961120.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The Lorenz Fiducial Screw is intended for establishing fixed reference point(s) in patients requiring stereotactic surgery. The Fiducial Screw can be used as an accessory with frameless navigation systems, as appropriate, from other manufacturers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K010427 · printed Nov 5, 2026
Cite this page
510(k) Report. “K010427: Lorenz Fiducail Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010427
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026