# K062310: Reflex Hybrid Acp System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Aug 18, 2006 after 10 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000536 (2000). 3 ancestors in all.
22 later devices descend from it; 6 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)
- K040261: Reflex Hybrid Anterior Cervical Plate System, Stryker Spine (2004) Summary page 1.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K000742: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.

## Most influential descendants
- K083562: Stryker Spine Nulock Anterior Cervical Plating System (2009), 16 descendants of its own
- K142237: Aviator Anterior Cervical Plate (ACP) System (2015), 9 descendants of its own
- K190227: Boomerang™ Anterior Cervical Plate System (2019), 4 descendants of its own
- K150759: Hyper-C Anterior Cervical Plate System (2015), 4 descendants of its own
- K083020: Stryker Spine Reflex Translational Anterior Cervical Plating System (2009), 3 descendants of its own

## Recalls of this device
- Oct 12, 2009 · Not classified · Z-0763-2010: The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attem
- Oct 12, 2009 · Not classified · Z-0762-2010: The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attem

## Indications for use
The Reflex TM Hybrid 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

Source page: https://510kreport.com/device/K062310
Methodology: https://510kreport.com/methodology