# K212756: Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: May 5, 2022 after 247 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: 8 generations back to K983831 (1999). 22 ancestors in all.
5 later devices descend from it; 2 cite it directly.
3 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201661: Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set, Medos International SARL (2020) Summary page 4.
- K122211: Synthes Navigable Pedicle Preparation Instruments, Synthes Spine (2012) Summary page 4.
- K212245: Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning, Brainlab AG (2022). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K223108: TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) (2023), 4 descendants of its own
- K233254: TELIGEN System Navigation Ready Instruments (2024), 2 descendants of its own
- K241893: CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (2024), 1 descendant of its own
- K254157: CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (2026), 0 descendants of its own
- K223438: TELIGEN System Peripheral Motor Nerve Stimulation Indications (2023), 0 descendants of its own

## Indications for use
The Discectomy Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures to facilitate disc space preparation, including discectomy or bony resection. These are indicated for use in surgical spinal procedures, in which: • the use of stereotactic surgery may be appropriate, and • reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated navigation arrays. These procedures include but are not limited to spinal fusion. The Discectomy Navigation Ready instruments can be pre-calibrated with the Brainlab Navigation System. The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which: • the use of stereotactic surgery may be appropriate, and • reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays. These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instrument, when used with UNAS, can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

Source page: https://510kreport.com/device/K212756
Methodology: https://510kreport.com/methodology