# K232218: Zenius™ Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medyssey USA, Inc.
- Decided: Aug 24, 2023 after 29 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 K990745 (1999). 110 ancestors in all.
No later device cites it as a predicate yet.
1 of 111 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093104: Medyssey CO., LTD., Zenius Spinal System, Medyssey Co, Ltd. (2010) Summary page 4.
- K103272: Zenius Spinal System, Medyssey Co, Ltd. (2010) Summary page 4.
- K121670: Medyssey Cannulated Pedicle Screw, Medyssey Co, Ltd. (2013) Summary page 4.
- K171526: Zenius™, lliad™ and Kora™ Spinal Fixation Systems, Medyssey USA, Inc. (2017) Summary page 4.

## Indications for use
The Medyssey Co, Ltd. Zenius Spinal 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/K232218
Methodology: https://510kreport.com/methodology