# K111811: Bendini (TM) Spinal Rod Bending System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Dec 5, 2011 after 161 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: 1 generation back to K050438 (2005). 1 ancestor in all.
36 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 1.

## 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

## Indications for use
The BendinTM 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/K111811
Methodology: https://510kreport.com/methodology