# K122211: Synthes Navigable Pedicle Preparation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Dec 17, 2012 after 145 days
- Product code: HAW (Neurological 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: 5 generations back to K983831 (1999). 12 ancestors in all.
20 later devices descend from it; 8 cite it directly.
1 of 33 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070106: VV Fluoro 3D, Brainlab AG (2007) Summary page 1.
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 1.
- K003111: Stryker Navigation System-Spine & Fluoroscopy Modules, Stryker Instruments (2001)

## Most influential descendants
- K191943: SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set (2019), 8 descendants of its own
- K201661: Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set (2020), 7 descendants of its own
- K170937: VIPER PRIME navigated inserter (2017), 6 descendants of its own
- K212756: Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set (2022), 5 descendants of its own
- K231280: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement (2023), 4 descendants of its own

## Indications for use
The Synthes Navigable Pedicle Preparation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebra 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. These procedures include but are not limited to spinal fusion.

Source page: https://510kreport.com/device/K122211
Methodology: https://510kreport.com/methodology