# K171509: Iliad® Pedicle Screw System and Zenius® Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Medyssey USA, Inc.
- Decided: Jun 12, 2017 after 20 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: 12 generations back to K853033 (1985). 154 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 156 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142835: Iliad Pedicle Screw System and Zenius Pedicle Screw System, Medyssey USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K181978: Zenius™, Iliad™ and Kora™ Spinal Fixation Systems (2018), 0 descendants of its own

## Indications for use
The Medyssey Co, Ltd. Iliad and Zenius Spinal Systems are 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/K171509
Methodology: https://510kreport.com/methodology