# K230989: Rod Registration Frame

- Pathway: 510(k) (Special)
- Applicant: Nu Vasive, Incorporated
- Decided: May 5, 2023 after 29 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: 21 generations back to K003155 (2001). 364 ancestors in all.
No later device cites it as a predicate yet.
2 of 365 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210574: NuVasive Pulse System, Nu Vasive, Incorporated (2021) Summary page 4.

## Indications for use
The surgical instruments are specifically designed for use with the Pulse System, which enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate. When used with a Pulse Navigation system, the patient reference hardware is intended to provide a reference to a rigid anatomical structure that can be identified relative to the acquired image of the anatomy.

Source page: https://510kreport.com/device/K230989
Methodology: https://510kreport.com/methodology