# K220038: Camber Spine Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Apr 29, 2022 after 114 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: 18 generations back to K040583 (2004). 418 ancestors in all.
No later device cites it as a predicate yet.
1 of 419 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153442: CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 5.
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps, Medtronic Navigation, Inc. (2013) Summary page 5.
- K180980: ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System, Camber Spine Technologies, LLC (2018) Summary page 5.

## Indications for use
Camber Spine Navigation System instruments are intended to be used in the preparation and placement of ORTHROS Posterior Stabilization System and ORTHROS MIS Posterior Stabilization System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

Source page: https://510kreport.com/device/K220038
Methodology: https://510kreport.com/methodology