# K151921: Sterispine PS

- Pathway: 510(k) (Traditional)
- Applicant: Safe Orthopaedics
- Decided: Oct 8, 2015 after 87 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: 6 generations back to K921873 (1992). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011437: Synergy 4.0 MM, 4.5 MM VLS Screws, Interpore Cross Intl. (2001) Summary page 4.
- K112453: Sterispineps Pedicle Screw, Safe Orthopaedics (2011) Summary page 4.

## Most influential descendants
- 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™PS 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 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/K151921
Methodology: https://510kreport.com/methodology