# K122378: Nextgen Altius Oct System

- Pathway: 510(k) (Special)
- Applicant: Biomet Spine (Aka Ebi, LLC)
- Decided: Sep 20, 2012 after 45 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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: 14 generations back to K003155 (2001). 98 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113593: Nextgen Altius Oct System, Biomet Spine (Aka Ebi, LLC) (2012)
- 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)

## Most influential descendants
- K162575: Z-LINKPC System (2017), 3 descendants of its own
- K131833: Centurion Poct System (2014), 2 descendants of its own
- K250866: Sovereign Posterior Cervical System (2025), 1 descendant of its own
- K254260: The VEGA Cervical Screw System (2026), 0 descendants of its own
- K231811: Zavation Connector System (2023), 0 descendants of its own

## Recalls of this device
- Jul 22, 2015 · Class II · Z-2759-2015: Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design con

## Indications for use
When intended for stabilization as afi adjunct to fuision 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 T I-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/K122378
Methodology: https://510kreport.com/methodology