# K043229: Modification to Altius Oct System

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: Dec 21, 2004 after 29 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.
142 later devices descend from it; 10 cite it directly.
0 of 143 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
- K113593: Nextgen Altius Oct System (2012), 102 descendants of its own
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System (2013), 75 descendants of its own
- K131615: Polaris Spinal System (2013), 70 descendants of its own
- K133746: Polaris Spinal System (2014), 67 descendants of its own
- K143248: Reform Pedicle Screw System (2014), 30 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/K043229
Methodology: https://510kreport.com/methodology