510(k) · Cleared
Recalled · Class II · 2026Ndi Passive Spheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Northern Digital, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jan 27, 2004 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 38 later devices descend from it. It has been recalled 28 times.
- Decided
- Jan 27, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 28
- Predicates
- 0
38 later devices descend from it, 3 citing it directly.
- This deviceK033621 Ndi Passive SpheresNorthern Digital, Inc. · 2004
- Descendant · cites it directly · 35 of its ownK122742 Nuvasive Bendini Spinal Rod Bending SystemNuvasive, Inc. · 2012
- Descendant · 2 generations on · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- Descendant · 3 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- Descendant · 4 generations on · 23 of its ownK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- Descendant · 5 generations on · 22 of its ownK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
2011high 4 (2017) · low 0 (2020)2026
Most influential descendants
Showing 5 of 38 · See all- K122742Nuvasive Bendini Spinal Rod Bending SystemNuvasive, Inc. · 2012 · cites it directly35descendants
- K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · 2 generations on33descendants
- K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 3 generations on24descendants
- K141968Nuvasive NVM5 SystemNuvasive, Inc. · 2014 · 4 generations on23descendants
- K143641NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · 5 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033621 | Ndi Passive Spheres | Northern Digital, Inc. | 2004 | — |
| +1 | K122742 | Nuvasive Bendini Spinal Rod Bending System | Nuvasive, Inc. | 2012 | — |
| +2 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| +3 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| +4 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| +5 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (38)
See all 383 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 31, 2026 | Class II | Z-0195-2027 | Under Investigation by firm | Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres. |
| Aug 31, 2026 | Class II | Z-0196-2027 | Under Investigation by firm | Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres. |
| Aug 31, 2026 | Class II | Z-0194-2027 | Under Investigation by firm | Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres. |
| Apr 24, 2014 | Class II | Z-1581-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1600-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1582-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1587-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1601-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1591-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1584-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1578-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1580-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1595-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1594-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1593-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1596-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1590-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1589-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1598-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1592-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1585-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1579-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1602-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1583-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1599-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1588-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1597-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1586-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
The 5 latest of 28 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122742 (Nuvasive, Inc., 2012) has gone furthest, with 35 descendants of its own.
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
2007high 15 (2007) · low 3 (2013)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
2007high 238 (2014) · low 66 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
2007high 28 (2010) · low 1 (2020)2026
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
2007high 6,062 (2019) · low 49 (2007)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?
For use as a stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structure in either open or percutaneous image guided surgery. It is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate, and where a reference to a rigid anatomical structure can be identified relative to a CT or MR-based model of the anatomy.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033621: Ndi Passive Spheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033621
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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