# K131878: Lliad, Kora, Zenius Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey USA, Inc.
- Decided: Aug 23, 2013 after 60 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: 10 generations back to K990745 (1999). 109 ancestors in all.
8 later devices descend from it; 3 cite it directly.
1 of 118 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121670: Medyssey Cannulated Pedicle Screw, Medyssey Co, Ltd. (2013) Summary page 2.
- K110283: Zenius Spinal System, Medyssey Co, Ltd. (2011) Summary page 2.
- K110284: Novel Iii Spinal Fixation and Adjustable Bridge System, Medyssey Co, Ltd. (2011) Summary page 2.

## Most influential descendants
- K142835: Iliad Pedicle Screw System and Zenius Pedicle Screw System (2015), 5 descendants of its own
- 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

## Indications for use
The Medyssey Co, Ltd. Zenius, Iliad and Kora 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 (ODD) (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 lordlosis); tumor; pseudloarthrosis; and failed previous fusion

Source page: https://510kreport.com/device/K131878
Methodology: https://510kreport.com/methodology