# K050804: Modification to: Spectrumtm Cervical Spinal System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Apr 11, 2005 after 12 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 K993855 (1999). 2 ancestors in all.
11 later devices descend from it; 1 cites 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)
- K022997: Spectrum Cervical Spinal System, Spinal Innovations, LLC (2002) Summary page 2.
- K993855: Atlantis Anterior Cervical Plate System, Danek Medical, Inc. (1999) Summary page 2.

## Most influential descendants
- 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
- K173128: Alamo® C (2018), 2 descendants of its own

## Indications for use
The SPECTRUMTM Cervical Plating System is intended for anterior intervertebral body screw fixation 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 disk confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/of failed previous fusions. WARNING: This device is not approved for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K050804
Methodology: https://510kreport.com/methodology