# K132280: Altus Spine Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Altus Partners
- Decided: Oct 31, 2013 after 100 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 9 generations back to K951116 (1995). 28 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033352: Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2004) Summary page 1.
- K043152: Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2005) Summary page 1.
- K051716: Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2005) Summary page 1.
- K071376: Modification to Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2007) Summary page 1.
- K081597: Modification to Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2008) Summary page 1.

## Most influential descendants
- K151648: Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System (2015), 5 descendants of its own
- 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

## Indications for use
The Altus Spine Pedlicle Screw System is a noncervical spinal fixation device intended to provide stabilization of the spinal segments. It is indicated for pedlicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (15-Si) vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft only having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the Altus Spine Pedlicle Screw System may be used to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: 1. Degenerative Spondylolisthesis with objective evidence of neurologic impairment; 2. Fracture; 3. Dislocation; 4. Scoliosis; 5. Kyphosis; 6. Spinal Tumor; 7. Failed previous fusion (pseudoarthrosis). When used as a non-posterior, non-pedicle anterolateral fixation system the specific indications are: 1. Degenerative disc disease as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; 2. Spondylolisthesis; 3. Fracture; 4. Dislocation; S. Scoliosis; 6. Kyphosis; 7. Lordlosis; 8. Spinal stenosis; 9. Spinal tumor; 10. Failed previous fusion (pseudoarthrosis)

Source page: https://510kreport.com/device/K132280
Methodology: https://510kreport.com/methodology