510(k) · Cleared
Recalled · Class II · 2015Disposable Reflective Marker Spheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HAW Neurological Stereotaxic Instrument
Cleared on Jul 14, 2010 as substantially equivalent to K082060 (Brainlab AG, 2009) after a 188-day review. Its family tree reaches back 4 generations to 1999. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 14, 2010
- Review
- 188 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983831 (1999). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 3 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 2 generations backK042391 Kolibri Image Guided Surgery SystemBrainlab AG · 2004
- 1 generation backK082060 Cranial Image Guided Surgery SystemBrainlab AG · 2009
- This deviceK100038 Disposable Reflective Marker SpheresBrainlab AG · 2010
- Descendant · cites it directly · 1 of its ownK103192 Navigation Marker, Reflective Marker SpheresIlumark GmbH · 2011
- Descendant · cites it directly · 0 of its ownK111443 X12 Sterile Reflective Marker SpherePinsco Inc. Dba B & L Engineering · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −3 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −2 | K042391 | Kolibri Image Guided Surgery System | Brainlab AG | 2004 | — |
| −1 | K082060 | Cranial Image Guided Surgery System | Brainlab AG | 2009 | — |
| 0 (this device) | K100038 | Disposable Reflective Marker Spheres | Brainlab AG | 2010 | — |
| +1 | K103192 | Navigation Marker, Reflective Marker Spheres | Ilumark GmbH | 2011 | — |
| +1 | K111443 | X12 Sterile Reflective Marker Sphere | Pinsco Inc. Dba B & L Engineering | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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? (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 |
|---|---|---|---|
| * | K082060 | Cranial Image Guided Surgery SystemSummary page 1…ective Marker Spheres Regulation number: 21 CFR 882.4560 Product codes: HAW, OLO Predicate Device: Cranial Image Guided Surgery System K082060 Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class 1I This submission does not change the indications fo… | 2009 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Aug 18, 2015 | Class II | Z-2795-2015 | Process control | Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together. |
| Jun 10, 2015 | Class II | Z-2084-2015 | Process control | Inadequate curing of adhesive, may cause the two halves of the spheres to separate. |
| May 20, 2015 | Class II | Z-2093-2015 | Process control | Inadequate curing of adhesive, which may cause the two halves of the spheres to separate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K103192 (Ilumark GmbH, 2011) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K082060.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling infrared tracking systems to detect the position of the patient and instruments in the surgical field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100038 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100038: Disposable Reflective Marker Spheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100038
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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