# K103505: Altum Anterior Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Spinecraft, LLC
- Decided: Mar 15, 2011 after 106 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971730 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020649: Envision Anterior Cervical Plate System, Ortho Development Corp. (2002) Summary page 1.
- K971730: Depuy Motech Peak Polyaxial Anterior Cervical Plate System, Depuy, Inc. (1997) Summary page 2.
- K052292: Spider Cervical Plating (SCP) System, X-Spine Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- K131521: Velox Anterior Cervical Plate System (2013), 0 descendants of its own

## Recalls of this device
- Nov 9, 2011 · Not classified · Z-0459-2012: Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line.

## Indications for use
The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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), * spondylolisthesis, * trauma (i.e. fractures or dislocations), * tumors, " deformity, * pseudarthrosis, * failed previous fusion, " spinal stenosis.

Source page: https://510kreport.com/device/K103505
Methodology: https://510kreport.com/methodology