# K170937: VIPER PRIME navigated inserter

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Sep 14, 2017 after 168 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: 6 generations back to K983831 (1999). 13 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122211: Synthes Navigable Pedicle Preparation Instruments, Synthes Spine (2012) Summary page 4.

## Most influential descendants
- 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
- K233944: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (2024), 3 descendants of its own
- K240846: CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement (2024), 2 descendants of its own
- K233793: CarboClear® X Pedicle Screw System (2024), 1 descendant of its own
- K243106: CarboClear® Hybrid Pedicle Screw System (2024), 0 descendants of its own

## Indications for use
The VIPER PRIME navigated inserter is a navigated instrument for insertion of VIPER PRIME screws in open or percutaneous procedures. The VIPER PRIME navigated inserter is indicated for use in spinal surgical procedures, in which: • use of the VIPER System is indicated, • use of stereotactic surgery may be appropriate, and • where 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 which includes universal tracking arrays supplied by the navigation manufacturer. These procedures include but are not limited to spinal fusion. The VIPER PRIME navigated inserter requires manual calibration.

Source page: https://510kreport.com/device/K170937
Methodology: https://510kreport.com/methodology