# K180550: NuVasive Monolith Cervical Corpectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Nov 20, 2018 after 264 days
- Product code: PLR (Spinal Vertebral Body Replacement Device - Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K003155 (2001). 32 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151651: NuVasive X-CORE Mini Cervical Expandable VBR System, Nu Vasive, Incorporated (2015) Summary page 4.
- K170271: NuVasive (r) Monolith Corpectomy System, Nu Vasive, Incorporated (2017) Summary page 4.
- K081611: Nuvasive Coroent System, Nuvasive, Inc. (2008) Summary page 4.

## Most influential descendants
- K191778: Omnia Medical VBR (2019), 5 descendants of its own
- K190426: ALTA Anterior Cervical Corpectomy System (2019), 3 descendants of its own
- K233359: DOMINION Expandable Corpectomy System (2024), 2 descendants of its own
- K241468: Vertiwedge® Intraosseous System (2024), 1 descendant of its own
- K202637: F3D Corpectomy System (2020), 1 descendant of its own

## Indications for use
The NuVasive Monolith Cervical Corpectomy System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive® Monolith Cervical Corpectomy System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive® Monolith Cervical Corpectomy System is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.

Source page: https://510kreport.com/device/K180550
Methodology: https://510kreport.com/methodology