# K112453: Sterispineps Pedicle Screw

- Pathway: 510(k) (Abbreviated)
- Applicant: Safe Orthopaedics
- Decided: Nov 15, 2011 after 82 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: 5 generations back to K921873 (1992). 13 ancestors in all.
10 later devices descend from it; 9 cite 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)
- K101437: Speedfix Suture System, Arthrocare Corp. (2010)

## Most influential descendants
- K121299: Sterispineps Pedicle Screw, Sterispineps Rod (2012), 6 descendants of its own
- K130632: Sterispine PS Pedicle Screw (2013), 5 descendants of its own
- K150092: STERISPINE PS Pedicle Screw (2015), 4 descendants of its own
- K140802: Sterispine PS (2014), 4 descendants of its own
- K151921: Sterispine PS (2015), 3 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 (DOD) (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/K112453
Methodology: https://510kreport.com/methodology