# K042235: Orion Anterior Cervical Plating System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Sep 17, 2004 after 30 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 K973854 (1998). 1 ancestor in all.
684 later devices descend from it; 3 cite it directly.
1 of 686 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.

## 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.

Source page: https://510kreport.com/device/K042235
Methodology: https://510kreport.com/methodology