# K190227: Boomerang™ Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Choicespine, LP
- Decided: May 1, 2019 after 85 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: 5 generations back to K031276 (2003). 21 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 5.
- K143576: Exactech Ambassador, Exactech, Inc. (2015) Summary page 5.
- K030500: Oria Zenith, Ortho Tec, LLC (2003) Summary page 5.
- K982443: Doc Ventral Cervical Stabilization System, Depuy Motech Acromed (1998) Summary page 5.
- K083562: Stryker Spine Nulock Anterior Cervical Plating System, Stryker Corp. (2009) Summary page 5.

## Most influential descendants
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own
- K250486: Skyway Anterior Cervical Plate System (2025), 1 descendant of its own
- K261451: ZSAlign Cervical Interbody System (2026), 0 descendants of its own
- K243369: Cervical Plating System (2024), 0 descendants of its own

## Indications for use
The ChoiceSpine BoomerangTM Anterior Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. WARNING: This device 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/K190227
Methodology: https://510kreport.com/methodology