# K211027: Altus Spine Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Altus Partners, LLC
- Decided: Sep 16, 2022 after 528 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: 19 generations back to K853033 (1985). 227 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 230 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200922: Altus Spine HA Pedicle Screw System, Altus Partners, LLC (2021) Summary page 4.
- K181339: Altus Spine Pedicle Screw System, Altus Partners, LLC (2018) Summary page 4.
- K200322: Altus Spine Pedicle Screw System, Altus Partners, LLC (2020) Summary page 4.
- K033352: Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2004) Summary page 4.
- K071880: Optima ZS Transition Screw, Zimmer Spine, Inc. (2007) Summary page 4.
- K031175: Click'x Monoaxial Screws and Hooks, Synthes (Usa) (2003) Summary page 4.

## Most influential descendants
- K230766: Altus Spine Monaco Pedicle Screw System (2023), 1 descendant of its own
- K243419: Altus Spine Navigation System (2025), 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/K211027
Methodology: https://510kreport.com/methodology