# K042499: Orion Anterior Cervical Plating System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Oct 7, 2004 after 23 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
Longest line of descent: 1 generation back to K792352 (1979). 3 ancestors in all.
694 later devices descend from it; 4 cite it directly.
1 of 698 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973854: Orion Anterior Cervical Plate System, Sofamor Danek USA,Inc. (1998) Summary page 1.
- K792352: Synthes Cervical Vertabrae Plates, DePuy Synthes (1979) Summary page 1.
- K802462: Synthes Spinal Implant System, Synthes (Usa) (1980) Summary page 1.

## Most influential descendants
- K042922: Venture Anterior Cervical Plating System (2004), 677 descendants of its own
- K061274: Venture Anterior Cervical Plate System (2006), 669 descendants of its own
- K073285: Peek Prevail Cervical Interbody Device (2008), 637 descendants of its own
- K094042: Peek Prevail Cervical Interbody Device (2010), 397 descendants of its own
- K100214: Cornerstone PSR Cervical Interbody Fusion Device (2010), 389 descendants of its own

## Indications for use
The ORION® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K042499
Methodology: https://510kreport.com/methodology