# K151648: Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Altus Partners, LLC
- Decided: Oct 16, 2015 after 120 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K853033 (1985). 231 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 237 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131802: Expedium, Viper. Viper 2 Spine System, Depuy Spine, A Johnson & Johnson Company (2013) Summary page 4.
- K131250: Tiger Spine System, Corelink, LLC (2013) Summary page 4.
- K132280: Altus Spine Pedicle Screw System, Altus Partners (2013) Summary page 4.
- K071376: Modification to Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2007) Summary page 5.
- K033352: Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2004) Summary page 5.

## Most influential descendants
- K221332: OsteoCentric Spine MIS Pedicle Fastener System (2022), 1 descendant of its own
- K181281: Altus Spine Pedicle Screw System (2018), 1 descendant of its own
- K250520: OsteoCentric Navigated Instruments System (2025), 0 descendants of its own
- K243419: Altus Spine Navigation System (2025), 0 descendants of its own
- K200981: Mega Plus MIS Spine System (2020), 0 descendants of its own

## Indications for use
The Altus Spine Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K151648
Methodology: https://510kreport.com/methodology