510(k) · Cleared
ClearedX12 Sterile Reflective Marker Sphere
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pinsco Inc. Dba B & L Engineering · OLO Orthopedic Stereotaxic Instrument
Cleared on Sep 29, 2011 as substantially equivalent to K100038 (Brainlab AG, 2010) and 2 other predicates after a 128-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Sep 29, 2011
- Review
- 128 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K983831 (1999). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 4 generations backK042391 Kolibri Image Guided Surgery SystemBrainlab AG · 2004
- 3 generations backK082060 Cranial Image Guided Surgery SystemBrainlab AG · 2009
- 2 generations backK100038 Disposable Reflective Marker SpheresBrainlab AG · 2010 · Recalled
- 1 generation backK103192 Navigation Marker, Reflective Marker SpheresIlumark GmbH · 2011
- This deviceK111443 X12 Sterile Reflective Marker SpherePinsco Inc. Dba B & L Engineering · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −5 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −4 | K042391 | Kolibri Image Guided Surgery System | Brainlab AG | 2004 | — |
| −3 | K082060 | Cranial Image Guided Surgery System | Brainlab AG | 2009 | — |
| −2 | K100038 | Disposable Reflective Marker Spheres | Brainlab AG | 2010 | 3 |
| −1 | K103192 | Navigation Marker, Reflective Marker Spheres | Ilumark GmbH | 2011 | — |
| 0 (this device) | 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 | 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 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? (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 |
|---|---|---|---|
| * | K100038 | Disposable Reflective Marker SpheresSummary page 1…Name Common Name Product Code 5 10(k) Number Date BrainLAB AG Disposable Reflective HAW, OLO K100038 July 14, 20 10 _________________ MarkerSpheres ________________ Northern Digital NDI Pa… | 2010 |
| * | K033621 | Ndi Passive SpheresSummary page 1…July 14, 20 10 _________________ MarkerSpheres ________________ Northern Digital NDI Passive Spheres HAW K033621 January 27, 2004 ILUMARK GmbH Navigation Marker HAW, OLO Ki103192 February 7, 20… | 2004 |
| * | K103192 | Navigation Marker, Reflective Marker SpheresSummary page 1…l NDI Passive Spheres HAW K033621 January 27, 2004 ILUMARK GmbH Navigation Marker HAW, OLO Ki103192 February 7, 2011 9. Device Description: X12's Sterile Reflective Marker Spheres consist of two hemispheres, co… | 2011 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K100038.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Used as an accessory to aid in the auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111443 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111443: X12 Sterile Reflective Marker Sphere.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111443
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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