# K093804: Nuvasive Helix Revolution Acp System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Feb 19, 2010 after 70 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Helix ACP System: named in the summary without a submission number

## 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 HELIX Revolution Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseuclarthrosis or failed previous fusion. WARNING: The NuVasive HELIX Revolution Anterior Cervical Plating System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K093804
Methodology: https://510kreport.com/methodology