# K081597: Modification to Vertebron PSS Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Vertebron, Inc.
- Decided: Jul 2, 2008 after 26 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: 8 generations back to K951116 (1995). 27 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K131810: Osseus Black Diamond Pedicle Screw System (2013), 14 descendants of its own
- K192121: Black Diamond Pedicle Screw System (2019), 13 descendants of its own
- K213935: PISCES-SA Standalone ALIF Interbody System (2022), 12 descendants of its own
- K132280: Altus Spine Pedicle Screw System (2013), 6 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own

## Indications for use
The VERTEBRON PSSTM Pedicle Screw System is intended for non-cervical, non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin 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 VERTEBRON PSSTM Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); 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/K081597
Methodology: https://510kreport.com/methodology