# K033621: Ndi Passive Spheres

- Pathway: 510(k) (Traditional)
- Applicant: Northern Digital, Inc.
- Decided: Jan 27, 2004 after 70 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 28 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
38 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122742: Nuvasive Bendini Spinal Rod Bending System (2012), 35 descendants of its own
- K123307: Nuvasive NVM5 System (2013), 33 descendants of its own
- K132694: Nuvasive NVM5 System (2014), 24 descendants of its own
- K141968: Nuvasive NVM5 System (2014), 23 descendants of its own
- K143641: NuVasive NVM5 System (2015), 22 descendants of its own

## Recalls of this device
- Aug 31, 2026 · Class II · Z-0195-2027: 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: 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: 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: 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 prod
- Apr 24, 2014 · Class II · Z-1600-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1582-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1587-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1601-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1591-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1584-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1578-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1580-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1595-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1594-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1593-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1596-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1590-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1589-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1598-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1592-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1585-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1579-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1602-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1583-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1599-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1588-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1597-2014: 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 prod
- Apr 24, 2014 · Class II · Z-1586-2014: 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 prod

## Indications for use
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.

Source page: https://510kreport.com/device/K033621
Methodology: https://510kreport.com/methodology