# K203023: Pisces Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corporation
- Decided: Jul 14, 2021 after 285 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). 131 ancestors in all.
No later device cites it as a predicate yet.
0 of 132 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The Pisces Spinal 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, sacrum and iliac spine (T1-Sacrum/Ilium) 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/K203023
Methodology: https://510kreport.com/methodology