# K190526: High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Sep 19, 2019 after 199 days
- Product code: PML (Bone Cement, Posterior Screw Augmentation)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K040583 (2004). 287 ancestors in all.
28 later devices descend from it; 2 cite it directly.
1 of 316 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161114: HIGH V+, Teknimed Sas (2017) Summary page 5.
- K180498: NuVasive Reline Fenestrated Screws, High V+ Bone Cement, Nu Vasive, Incorporated (2018) Summary page 5.
- K173487: CarboClear® Pedicle Screw System, CarboFix Orthopedics, Ltd. (2018) Summary page 6.
- K182377: CarboClear® Pedicle Screw System, CarboFix Orthopedics, Ltd. (2018) Summary page 6.

## Most influential descendants
- 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
- K222789: VADER® Pedicle System, G21 Cement (2023), 5 descendants of its own
- K242364: IdentiTi™ II Interbody System (2024), 4 descendants of its own

## Indications for use
When used in conjunction with the CarboClear Fenestrated Pedicle Screws, High V+ Bone Cement 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. High V+ Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised. When used in conjunction with High V+ Bone Cement, the CarboClear Fenestrated Pedicle Screws are 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. CarboClear Fenestrated Pedicle Screws augmented with High V+ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Source page: https://510kreport.com/device/K190526
Methodology: https://510kreport.com/methodology