# K100373: Tyche Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Kyung Won Medical Co., Ltd.
- Decided: Jun 30, 2010 after 138 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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: 5 generations back to K000319 (2000). 10 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K082453: 4CIS Solar and Apollon Spine Systems, Solco Biomedical Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K120353: Synster Pedicle Screw System Synster Plus Pedicle Screw System (2012), 3 descendants of its own
- K143110: GALAXY MIS Screw System (2015), 2 descendants of its own
- K201788: EDEN Spinal Fixation System (2022), 1 descendant of its own
- K230762: EDEN Spinal Fixation MIS System (2023), 0 descendants of its own

## Indications for use
The Tyche® Pedicle Screw System is a non-cervical, pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, The Tyche® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K100373
Methodology: https://510kreport.com/methodology