# K040261: Reflex Hybrid Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Apr 16, 2004 after 72 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
51 later devices descend from it; 9 cite it directly.
0 of 52 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) Reflex Anterior Cervical Plate System: named in the summary without a submission number

## Most influential descendants
- K043066: Pioneer Anterior Cervical Plate System (2005), 27 descendants of its own
- K053053: Pacp System (2005), 25 descendants of its own
- K062310: Reflex Hybrid Acp System (2006), 22 descendants of its own
- K072703: Pioneer Slimfuse Anterior Cervical Plating System (2008), 19 descendants of its own
- K083663: PACP (2009), 17 descendants of its own

## Recalls of this device
- Aug 18, 2008 · Not classified · Z-0217-2009: The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been anodized with the incorrect color for that screw.
- Jun 14, 2006 · Not classified · Z-1958-2009: Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.
- Jun 14, 2006 · Not classified · Z-1960-2009: Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.
- Jun 14, 2006 · Not classified · Z-1959-2009: Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.

## 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/K040261
Methodology: https://510kreport.com/methodology