# K121670: Medyssey Cannulated Pedicle Screw

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey Co, Ltd.
- Decided: Jan 25, 2013 after 233 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: 9 generations back to K990745 (1999). 108 ancestors in all.
11 later devices descend from it; 3 cite it directly.
1 of 120 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103272: Zenius Spinal System, Medyssey Co, Ltd. (2010) Summary page 1.
- K110283: Zenius Spinal System, Medyssey Co, Ltd. (2011) Summary page 1.
- K081153: Novel Spinal System, Medyssey Co, Ltd. (2009) Summary page 1.
- K103147: Novel Iii Spinal Fixation and Adjustable Bridge System, Medyssey Co, Ltd. (2010) Summary page 1.
- K110284: Novel Iii Spinal Fixation and Adjustable Bridge System, Medyssey Co, Ltd. (2011) Summary page 1.
- K092929: Synthes Matrix System, Synthes (Usa) (2009) Summary page 1.
- K100634: Synthes Matrix System, Synthes (Usa) (2010) Summary page 1.
- K100952: Modification to Synthes Matrix System, Synthes Spine (2010) Summary page 1.
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 1.
- K081195: Revere Uniplanar Screws, Globus Medical, Inc. (2008) Summary page 1.
- K091782: Revere 6.35 Stabilization System, Globus Medical, Inc. (2009) Summary page 1.
- K093294: Revere Stabilization System, Globus Medical, Inc. (2010) Summary page 1.
- K100788: Cocr Rods, Globus Medical, Inc. (2010) Summary page 1.
- K100623: Aesculap Implant Systems S4 Spinal System, Aesculap Implant Systems (2010) Summary page 1.
- K090657: Modification to: S4 Spinal System, Aesculap Implant Systems (2009) Summary page 1.
- K071945: S4 Spinal System, Aesculap Implant Systems (2007) Summary page 1.
- K062085: S4 Spinal System, Aesculap (2007) Summary page 1.
- K032219: Revolution Spinal Fixation System, Spinal Innovations, Inc. (2003) Summary page 1.

## Most influential descendants
- K131878: Lliad, Kora, Zenius Pedicle Screw System (2013), 8 descendants of its own
- 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
- K171526: Zenius™, lliad™ and Kora™ Spinal Fixation Systems (2017), 2 descendants of its own
- K171509: Iliad® Pedicle Screw System and Zenius® Pedicle Screw System (2017), 1 descendant 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 (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/K121670
Methodology: https://510kreport.com/methodology