# K022997: Spectrum Cervical Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Innovations, LLC
- Decided: Dec 6, 2002 after 88 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.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sofamor Danek Orion Anterior Cervical Plate System: named in the summary without a submission number
- (no number) Sofamor Danek Atlantis Anterior Cervical Plate System: named in the summary without a submission number
- (no number) Medtronic Sofamor Danek Zephir Anterior Cervical Plate System: named in the summary without a submission number
- (no number) Synthes Cervical Spine Locking Plate System: named in the summary without a submission number

## Most influential descendants
- K050804: Modification to: Spectrumtm Cervical Spinal System (2005), 11 descendants of its own
- K100243: Quintex Cervical Plating System (2010), 10 descendants of its own
- K141993: Nakoma Acp (2014), 8 descendants of its own
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own

## Indications for use
The Spinal Innovations SPECTRUM TM Cervical Spinal System is intended for anterior intervertebral body screw futation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine 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 hctures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, 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/K022997
Methodology: https://510kreport.com/methodology