# K182377: CarboClear® Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Sep 27, 2018 after 27 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K040583 (2004). 213 ancestors in all.
39 later devices descend from it; 8 cite it directly.
0 of 253 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173487: CarboClear® Pedicle Screw System, CarboFix Orthopedics, Ltd. (2018) Summary page 5.
- K052398: Mesa Spinal System, K2m, LLC (2005) Summary page 5.
- K130291: S4 Spinal System, Aesculap Implant System, Inc. (2013) Summary page 5.
- K981676: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1999) Summary page 5.

## Most influential descendants
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (2019), 29 descendants of its own
- K190526: High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (2019), 28 descendants of its own
- K200596: G21 Cement, VADER® Pedicle System (2020), 27 descendants of its own
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own

## Indications for use
The CarboClear Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced-stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Source page: https://510kreport.com/device/K182377
Methodology: https://510kreport.com/methodology