# K113593: Nextgen Altius Oct System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine (Aka Ebi, LLC)
- Decided: Apr 17, 2012 after 134 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: 13 generations back to K003155 (2001). 97 ancestors in all.
102 later devices descend from it; 6 cite it directly.
0 of 200 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043229: Modification to Altius Oct System, Interpore Cross Intl. (2004) Summary page 2.
- K033961: Altius Oct System, Interpore Cross Intl. (2004) Summary page 2.
- K022048: Interpore Cross International (Ici) Occipito-Cervico-Thoracic (Oct) Rod and Plate System, Interpore Cross Intl. (2002) Summary page 2.
- K110353: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2011) Summary page 2.
- K103100: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2010) Summary page 2.
- K080828: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2008) Summary page 2.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 2.
- K110522: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 2.
- K082728: Vertex Recontruction System, Vertex  Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2009) Summary page 2.
- K090714: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek (2009) Summary page 2.
- K083071: Vertex Reconstruction System, Medtronic Sofamor Danek (2008) Summary page 2.
- K091365: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Soafamor Danek (2009) Summary page 2.

## Most influential descendants
- 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
- K150856: Reform Pedicle Screw System (2015), 26 descendants of its own

## Indications for use
When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Nexigen Altius OCT System is intended for use with allograft or autograft and indicated for: ODD (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 lotdosis); 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 TI-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/K113593
Methodology: https://510kreport.com/methodology