# K200922: Altus Spine HA Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Altus Partners, LLC
- Decided: Jan 26, 2021 after 295 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: 18 generations back to K853033 (1985). 225 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 229 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200322: Altus Spine Pedicle Screw System, Altus Partners, LLC (2020). Cleared while this submission was under review Summary page 4.
- K182478: Whistler Modular Pedicle Screw System, Evolution Spine, LLC (2019) Summary page 4.

## Most influential descendants
- K211027: Altus Spine Pedicle Screw System (2022), 2 descendants of its own
- 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 HA 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 HA Pedicle Screw System is intended for noncervical pedicle 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. The Altus Spine HA Pedicle Screw System may be used for noncervical pedicle fixation via in posterior percutaneous approach with MIS instrumentation for the indications listed above. When used as an anterolateral thoracic/lumbar system the Altus Spine HA Pedicle Screw System may also be used for the same indications listed above as an adjunct to fusion.

Source page: https://510kreport.com/device/K200922
Methodology: https://510kreport.com/methodology