510(k) · Cleared
ClearedPrecision Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryptych Pty, Ltd. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 27, 2016 as substantially equivalent to K010427 (Walter Lorenz Surgical, Inc., 2001) after a 167-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Jul 27, 2016
- Review
- 167 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K854886 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK854886 Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. · 1986 · Recalled
- 2 generations backK961120 Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc. · 1996
- 1 generation backK010427 Lorenz Fiducail ScrewWalter Lorenz Surgical, Inc. · 2001
- This deviceK160385 Precision ScrewCryptych Pty, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K854886 | Wuerzburg Titanium Mini Bone Plates & Bone Screws | Walter Lorenz Surgical, Inc. | 1986 | 1 |
| −2 | K961120 | Marker System for Stereotaxic Navigation | Howmedica Leibinger, Inc. | 1996 | — |
| −1 | K010427 | Lorenz Fiducail Screw | Walter Lorenz Surgical, Inc. | 2001 | — |
| 0 (this device) | 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 |
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 OLO? 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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 |
|---|---|---|---|
| * | K010427 | Lorenz Fiducail ScrewSummary page 4…sory (21 CFR 882.4560) Regulatory Class: II Product Code: OLO Reason for Submission New Device ϭ.3 PREDICATE DEVICE Lorenz Fiducial Screw, K010427 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. ϭ.4 DE… | 2001 |
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 30 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The Precision Screw is intended for establishing fixed reference point(s) in patients undergoing Stereotactic Surgery for procedures in the cortical bone of the vertebrae. The Precision Screw can be used as an accessory with frameless navigation systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160385: Precision Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160385
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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