# K170271: NuVasive (r) Monolith Corpectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Mar 30, 2017 after 62 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- 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: 12 generations back to K003155 (2001). 29 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151167: NuVasive PEEK Corpectomy System, Nu Vasive, Incorporated (2015) Summary page 4.
- K151538: NuVasive PEEK Corpectomy Railed System, Nu Vasive, Incorporated (2015) Summary page 4.
- K142205: NuVasive X-CORE (R) Expandable VBR System, Nuvasive, Inc. (2015) Summary page 4.

## Most influential descendants
- K180550: NuVasive Monolith Cervical Corpectomy System (2018), 11 descendants of its own
- 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

## Indications for use
The NuVasive® Monolith Corpectomy System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The Monolith Corpectomy System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon’s discretion.

Source page: https://510kreport.com/device/K170271
Methodology: https://510kreport.com/methodology