# K073275: Nuvasive Helix Mini Acp System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Jan 29, 2008 after 69 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.
24 later devices descend from it; 7 cite it directly.
0 of 25 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
- K121060: Spine Frontier Indus Acp System (2012), 15 descendants of its own
- K153526: Pyrenees Cervical Plate System (2016), 6 descendants of its own
- K140234: Aspiron Acp System (2014), 6 descendants of its own
- K162664: Pyrenees Cervical Plate System (2016), 5 descendants of its own
- K191500: NuVasive® ACP System (2019), 4 descendants of its own

## Indications for use
The NuVasive HELIX Mini 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, pseudarthrosis or failed previous fusion. WARNING: The NuVasive HELIX Mini 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/K073275
Methodology: https://510kreport.com/methodology