# K010115: Reflex Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Apr 16, 2001 after 90 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K161641: LOSPA IS ACP System (2017), 0 descendants of its own

## Indications for use
The Reflex ACP System is intended for anterior inter-vertebral screw fixation of the cervical spine at levels C2-Tl. 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 ftactures) Tumors Deformities or curvatures (including kyphosis, lordosis or scoliosis) Pseudoarthrosis Failed previous fusion Decompression of the spinal cord following total or partial cervical vertebrectomy.

Source page: https://510kreport.com/device/K010115
Methodology: https://510kreport.com/methodology