# K142835: Iliad Pedicle Screw System and Zenius Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey USA, Inc.
- Decided: Jun 12, 2015 after 255 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: 11 generations back to K853033 (1985). 153 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 159 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042025: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2004) Summary page 5.
- K131878: Lliad, Kora, Zenius Pedicle Screw System, Medyssey USA, Inc. (2013) Summary page 5.
- K102249: Expedium Spine System, Depuy Spine, A Johnson & Johnson Company (2010) Summary page 5.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 5.
- K001272: Xia Spine System, Howmedica Osteonics Corp. (2000) Summary page 5.

## Most influential descendants
- K222229: Advanced LumFix Spinal Fixation System (2023), 2 descendants of its own
- K171509: Iliad® Pedicle Screw System and Zenius® Pedicle Screw System (2017), 1 descendant of its own
- K250582: COLONNADE Posterior Screw Fixation System (2025), 0 descendants of its own
- K231443: Mini-OSTEO Pedicle Fixation System (2023), 0 descendants of its own
- K181978: Zenius™, Iliad™ and Kora™ Spinal Fixation Systems (2018), 0 descendants of its own

## Indications for use
The Medyssey Co, Ltd. Iliad Pedicle Screw System and Zenius Pedicle Screw System 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/K142835
Methodology: https://510kreport.com/methodology