# K031214: Cyclone Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Sep 23, 2003 after 159 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 32 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K926453 (1993). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022344: Trinica Select Anterior Cervical Plate System, Centerpulse Spine-Tech, Inc. (2002) Summary page 1.
- K994239: Zephir Anterior Cervical Plate System, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.

## Most influential descendants
- K040397: Modification to Cyclone Anterior Cervical Plate System (2004), 0 descendants of its own

## Recalls of this device
- Mar 26, 2008 · Not classified · Z-1727-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1747-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1742-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1721-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1726-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1738-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1732-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1728-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1717-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1718-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1745-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1730-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1729-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1734-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1744-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1740-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1735-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1741-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1746-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1748-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1739-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1743-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1733-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1737-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1719-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1731-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1725-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1722-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1736-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1723-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1720-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Mar 26, 2008 · Not classified · Z-1724-2008: The screw locking cap may fracture when the surgeon rotates it into the locked position.

## Indications for use
The CycloneTMAnterior Cervical Plate System is intended for anterior Inter-body screw fixation to provide stabilization of cervical spinal fusion (C2-C7). This system is indicated for use in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the dlsc confirmed by patient history and radlographic studies), trauma (including fractures), tumors, deformity (defined as Kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Cyclonem Anterior Cervical Plate System is intended to provide stabilization during the process of cervical spinal fusion (C2-C7) in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

Source page: https://510kreport.com/device/K031214
Methodology: https://510kreport.com/methodology