# K140734: Nextgen Altius Oct System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, LLC
- Decided: Dec 15, 2014 after 266 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
Longest line of descent: 15 generations back to K003155 (2001). 109 ancestors in all.
No later device cites it as a predicate yet.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122378: Nextgen Altius Oct System, Biomet Spine (Aka Ebi, LLC) (2012) Summary page 5.
- K113593: Nextgen Altius Oct System, Biomet Spine (Aka Ebi, LLC) (2012) Summary page 5.
- K043229: Modification to Altius Oct System, Interpore Cross Intl. (2004) Summary page 5.
- K110522: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 5.
- K113434: Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS), Lanx, Inc. (2011) Summary page 5.
- K071905: Posterior Cervicothoracic Spinal Fixation System (PCFS), Lanx, LLC (2007) Summary page 5.

## Indications for use
When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only. The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine. The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system’s package insert for a list of indications for use for each system.

Source page: https://510kreport.com/device/K140734
Methodology: https://510kreport.com/methodology