# K040397: Modification to Cyclone Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: May 6, 2004 after 79 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: 4 generations back to K926453 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031214: Cyclone Anterior Cervical Plate System, Encore Medical L.P. (2003) Summary page 1.

## 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 Cyclone TM Anterior Cervical Plate is a unilateral fixation device 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/K040397
Methodology: https://510kreport.com/methodology