# K201926: CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Aug 7, 2020 after 28 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: 18 generations back to K040583 (2004). 222 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 233 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 6.
- K200519: CarboClear® II Pedicle Screw System, CarboFix Orthopedics, Ltd. (2020) Summary page 6.
- K052398: Mesa Spinal System, K2m, LLC (2005) Summary page 6.
- K981676: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1999) Summary page 6.

## Most influential descendants
- K203317: CarboClear X Pedicle Screw System (2020), 9 descendants of its own
- K210716: CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments (2021), 8 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
- 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

## 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. The CarboClear® II 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/K201926
Methodology: https://510kreport.com/methodology