# K153525: Seneka II Polyscrew Pedicle Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Senecka Spine
- Decided: Jan 28, 2016 after 50 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: 18 generations back to K040583 (2004). 350 ancestors in all.
No later device cites it as a predicate yet.
0 of 351 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151849: Seneka I Polyscrew Pedicle Fixation System, Senecka Spine (2015) Summary page 4.
- K013444: Isobar Spinal System, Scien'Tx USA, Inc. (2001) Summary page 4.
- K151216: Everest Spinal System, K2m, Inc. (2015) Summary page 4.

## Indications for use
The Seneka II Polyscrew Pedicle Fixation System is intended for posterior non-cervical fixation as an adjunct to fusion in skeletally mature patients 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Seneka II Polyscrew Pedicle Fixation System may also be used for the same indications as an adjunct to fusion.

Source page: https://510kreport.com/device/K153525
Methodology: https://510kreport.com/methodology