# K151849: Seneka I Polyscrew Pedicle Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Senecka Spine
- Decided: Sep 30, 2015 after 85 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: 4 generations back to K955348 (1996). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 4.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 4.
- K001319: Xia Spine System Hooks, Howmedica Osteonics Corp. (2000) Summary page 4.

## Most influential descendants
- K153525: Seneka II Polyscrew Pedicle Fixation System (2016), 0 descendants of its own

## Indications for use
The Seneka I Polyscrew Pedicle Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft 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.

Source page: https://510kreport.com/device/K151849
Methodology: https://510kreport.com/methodology