# K093104: Medyssey CO., LTD., Zenius Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey Co, Ltd.
- Decided: Jun 25, 2010 after 267 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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). 9 ancestors in all.
20 later devices descend from it; 5 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020279: Forex Corporation, Optima, Spinal System, Forex Corp. (2002) Summary page 1.
- K081153: Novel Spinal System, Medyssey Co, Ltd. (2009)

## Cited in the summary but kept off the family tree
- K024098: Cobas Integra Creatinine Plus Ver.2 Assay, Roche Diagnostics Corp. (2002). Our reading of the summary gave K024098, FDA’s number for Cobas Integra Creatinine Plus Ver.2 Assay (Roche Diagnostics Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “U&I Corporation, OPTIMA Spinal System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K103272: Zenius Spinal System (2010), 15 descendants of its own
- K110283: Zenius Spinal System (2011), 14 descendants of its own
- K121670: Medyssey Cannulated Pedicle Screw (2013), 11 descendants of its own
- K131878: Lliad, Kora, Zenius Pedicle Screw System (2013), 8 descendants of its own
- K160731: LumFix Spinal Fixation Sytem (2016), 6 descendants of its own

## Indications for use
The Medyssey Co. Ltd., ZeniusTm Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K093104
Methodology: https://510kreport.com/methodology