# K122742: Nuvasive Bendini Spinal Rod Bending System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Dec 7, 2012 after 91 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050438 (2005). 3 ancestors in all.
35 later devices descend from it; 2 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)
- K111811: Bendini (TM) Spinal Rod Bending System, Nuvasive, Inc. (2011) Summary page 2.
- K033621: Ndi Passive Spheres, Northern Digital, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K152942: NuVasiveNVM5 System (2016), 13 descendants of its own

## Indications for use
The Bendini Spinal Rod Bending System is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

Source page: https://510kreport.com/device/K122742
Methodology: https://510kreport.com/methodology