# K180498: NuVasive Reline Fenestrated Screws, High V+ Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Nov 28, 2018 after 275 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: 18 generations back to K040583 (2004). 174 ancestors in all.
41 later devices descend from it; 3 cite it directly.
1 of 216 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160989: NuVasive® Reline® System, Nu Vasive, Incorporated (2016) Summary page 4.
- K152604: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set, Medtronic Sofamor Danek USA, Incorporated (2016) Summary page 4.
- K161114: HIGH V+, Teknimed Sas (2017) Summary page 4.

## Most influential descendants
- 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
- K182974: NuVasive Reline System (2019), 11 descendants of its own

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

Source page: https://510kreport.com/device/K180498
Methodology: https://510kreport.com/methodology