# K033961: Altius Oct System

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: Apr 14, 2004 after 114 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
250 later devices descend from it; 13 cite it directly.
0 of 251 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 no predicate by number.

## Most influential descendants
- K100409: Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System (2010), 144 descendants of its own
- K100438: Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation System (2010), 104 descendants of its own
- K110906: Apex Spine System (2011), 103 descendants of its own
- K113593: Nextgen Altius Oct System (2012), 102 descendants of its own
- K113058: Tiger Spine System (2012), 81 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Interpore Cross International Altius OCT System is indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) Spondyloslisthesis Spinal stenosis Fracture/dislocation Atlantoaxial fracture with instability Occipitocervical dislocation Revision of previous cervical spine surgery Tumors The occipital bone screws are limited to occipital fixation only. The Altius OCT System can be linked to the Synergy Spinal System using the Transitional Rods and Rod Connectors from the Altius OCT System.

Source page: https://510kreport.com/device/K033961
Methodology: https://510kreport.com/methodology