510(k) · Cleared
ClearedSTarFix Designer Software C0265
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FHC, Inc. · QRI Surgical Planning Software For Neurological Stereotaxic Instruments
Cleared on Sep 8, 2023 as substantially equivalent to K092192 (FHC, Inc., 2010) after a 140-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Sep 8, 2023
- Review
- 140 days
- Class
- Class II
- Product code
- QRI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K854886 (1986). 9 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 backK092192 Waypoint Stereotactic SystemFHC, Inc. · 2010
- This deviceK231141 STarFix Designer Software C0265FHC, Inc. · 2023
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 | K092192 | Waypoint Stereotactic System | FHC, Inc. | 2010 | — |
| 0 (this device) | K231141 | STarFix Designer Software C0265 | FHC, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 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 QRI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K092192 | Waypoint Stereotactic SystemSummary page 4…l equivalence: The STarFix™Designer is substantially equivalent to FHC, Inc.’s Voxim and WayPoint™ Planner Planning Software, part of the WayPointTM Stereotactic System (K092192); decision date: February 12th 2010, product code: HAW 4. Description of device: FHC, Inc. STarFix™ Designer software is an adv… | 2010 |
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 37 years and passes through 3 companies; a new generation was cleared every 13.6 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K092192.
How does its category compare?
All QRI devicesQRI Surgical Planning Software For Neurological Stereotaxic Instruments: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QRI
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QRI
Too few QRI 510(k)s in any year since 2007 to give a median.
Recalls per year · QRI
No recall names QRI since 2007.
Adverse event reports per year · QRI
No MAUDE report names QRI since 2007.
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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The STarFix Designer Software is part of the WayPoint Stereotactic System. The WayPoint Stereotactic System is intended to be used with commercially available stereotactic system for neurological procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231141: STarFix Designer Software C0265.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231141
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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