# K162995: Ibis® Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corporation
- Decided: Mar 30, 2017 after 154 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: 14 generations back to K990745 (1999). 154 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142146: Ibis Pedicle Screw System, Ortho Development Corp. (2014) Summary page 4.
- K131785: Pagoda Pedicle Screw System, Ortho Development Corp. (2013) Summary page 4.
- K101993: Viper System, Expedium System, Depuy Spine, Inc. (2010) Summary page 4.

## Most influential descendants
- K161225: Paonan Armstrong Posterior Spinal Fixation System (2017), 2 descendants of its own
- K180226: TREND II Spinal Fixation System- STEP Series (2018), 1 descendant of its own
- K240233: Pitkar Spinal Pedicle Screw System (2024), 0 descendants of its own

## Indications for use
The Ibis® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – Sacrum/Ileum) for the following indications: 1) Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) 2) Degenerative Spondylolisthesis with objective evidence of neurologic impairment 3) Trauma (fracture or dislocation) 4) Spinal tumor 5) Failed previous fusion (pseudarthrosis) 6) Spinal stenosis 7) Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

Source page: https://510kreport.com/device/K162995
Methodology: https://510kreport.com/methodology