# K033352: Vertebron PSS Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Vertebron, Inc.
- Decided: Feb 25, 2004 after 128 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: 4 generations back to K951116 (1995). 18 ancestors in all.
62 later devices descend from it; 9 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970635: Titanium Spinal Rod System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 1.
- K022778: Modification to TSRH Spinal System, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.

## Most influential descendants
- K043152: Vertebron PSS Pedicle Screw System (2005), 61 descendants of its own
- K051716: Vertebron PSS Pedicle Screw System (2005), 56 descendants of its own
- K071376: Modification to Vertebron PSS Pedicle Screw System (2007), 49 descendants of its own
- K073430: Valeo Pedicle Screw Spinal System (2008), 24 descendants of its own
- K081597: Modification to Vertebron PSS Pedicle Screw System (2008), 22 descendants of its own

## Indications for use
The VertebronPSSPedicleScrewSystem is intended for 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., scoltosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The Vertebron PSS Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocazion); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally maLure patients.

Source page: https://510kreport.com/device/K033352
Methodology: https://510kreport.com/methodology