# K130632: Sterispine PS Pedicle Screw

- Pathway: 510(k) (Special)
- Applicant: Safe Orthopaedics
- Decided: May 3, 2013 after 56 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: 7 generations back to K921873 (1992). 15 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 21 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 2.
- K121299: Sterispineps Pedicle Screw, Sterispineps Rod, Safe Orthopaedics (2012) Summary page 1.

## Most influential descendants
- K140802: Sterispine PS (2014), 4 descendants of its own
- K151747: Sterispine PS (2015), 3 descendants of its own
- K170528: Sterispine™ PS (2017), 2 descendants of its own
- 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'P5 system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. SteriSpine'"PS System is intended for posterior, non-cervical pedlicle 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; pseudloarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K130632
Methodology: https://510kreport.com/methodology