# K031702: Reflex Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics
- Decided: Aug 8, 2003 after 67 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.
245 later devices descend from it; 3 cite it directly.
0 of 246 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) Synthes' Cervical Spine Locking Plate (CSLP) System: named in the summary without a submission number

## Most influential descendants
- K040721: Assure Anterior Cervical Plate System (2004), 178 descendants of its own
- K070775: Modification to: Providence Anterior Cervical Plate System (2007), 177 descendants of its own
- K081391: Vip Anterior Cervical Plate System (2008), 171 descendants of its own
- K142218: Coalition AGX Plate and Coalition AGX Spacer (2015), 155 descendants of its own
- K152022: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (2017), 149 descendants of its own

## Indications for use
The Reflex ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) Trauma (including fractures) Tumors Deformities or curvatures (including kyphosis, lordosis or scoliosis) Pseudoarthrosis Failed previous fusion Decompression of the spinal cord following total or partial cervical vertebrectomy. Spondylolisthesis Spinal Stenosis WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K031702
Methodology: https://510kreport.com/methodology