# K203253: NuVasive ACP System

- Pathway: 510(k) (Special)
- Applicant: Nu Vasive, Incorporated
- Decided: Dec 3, 2020 after 29 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: 6 generations back to K922087 (1992). 19 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K201078: NuVasive® ACP System, Nu Vasive, Incorporated (2020) Summary page 4.
- K191500: NuVasive® ACP System, Nu Vasive, Incorporated (2019) Summary page 4.
- K073275: Nuvasive Helix Mini Acp System, Nuvasive, Inc. (2008) Summary page 4.

## Most influential descendants
- 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/K203253
Methodology: https://510kreport.com/methodology