# K191500: NuVasive® ACP System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Sep 3, 2019 after 89 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- 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: 4 generations back to K922087 (1992). 17 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122910: Archon Anterior Cervical Plate Syste,, Nu Vasive, Incorporated (2012) Summary page 4.
- K073275: Nuvasive Helix Mini Acp System, Nuvasive, Inc. (2008) Summary page 4.
- K023133: Modification to Ebi Vuelock Anterior Cervical Plate System, Ebi, L.P. (2002) Summary page 4.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 4.

## Most influential descendants
- K201078: NuVasive® ACP System (2020), 3 descendants of its own
- K203253: NuVasive ACP System (2020), 2 descendants of its own
- K212446: NuVasive Anterior Cervical Plate Systems (2021), 1 descendant of its own
- K251965: Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (2025), 0 descendants of its own

## Indications for use
The NuVasive® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

Source page: https://510kreport.com/device/K191500
Methodology: https://510kreport.com/methodology