# K973854: Orion Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Mar 16, 1998 after 164 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
No predicates in its family tree.
831 later devices descend from it; 7 cite it directly.
1 of 832 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K042499: Orion Anterior Cervical Plating System (2004), 694 descendants of its own
- K042235: Orion Anterior Cervical Plating System (2004), 684 descendants of its own
- 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

## 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/K973854
Methodology: https://510kreport.com/methodology