# K170528: Sterispine™ PS

- Pathway: 510(k) (Special)
- Applicant: Safe Orthopaedics
- Decided: Mar 9, 2017 after 15 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: 10 generations back to K921873 (1992). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112453: Sterispineps Pedicle Screw, Safe Orthopaedics (2011) Summary page 4.
- K121299: Sterispineps Pedicle Screw, Sterispineps Rod, Safe Orthopaedics (2012) Summary page 4.
- K130632: Sterispine PS Pedicle Screw, Safe Orthopaedics (2013) Summary page 4.
- K140802: Sterispine PS, Safe Orthopaedics (2014) Summary page 4.
- K151747: Sterispine PS, Safe Orthopaedics (2015) Summary page 4.
- K151921: Sterispine PS, Safe Orthopaedics (2015) Summary page 4.

## Most influential descendants
- K201648: Sterispine™ PS (2020), 1 descendant of its own
- K260989: Varion Thoracolumbar Fixation System (2026), 0 descendants of its own

## Indications for use
The Sterispine™ PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct of fusion. Sterispine™ PS system is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (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; tumor; pseudoarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K170528
Methodology: https://510kreport.com/methodology