# K081153: Novel Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey Co, Ltd.
- Decided: Jan 30, 2009 after 282 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: 3 generations back to K955348 (1996). 5 ancestors in all.
23 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070300: Expedium SFX Cross Connector System, Depuy Spine, Inc. (2007) Summary page 3.
- K042635: Denali Spine System, K2m, LLC (2005) Summary page 3.

## Most influential descendants
- K093104: Medyssey CO., LTD., Zenius Spinal System (2010), 20 descendants of its own
- K103272: Zenius Spinal System (2010), 15 descendants of its own
- K110283: Zenius Spinal System (2011), 14 descendants of its own
- K103147: Novel Iii Spinal Fixation and Adjustable Bridge System (2010), 13 descendants of its own
- K110284: Novel Iii Spinal Fixation and Adjustable Bridge System (2011), 12 descendants of its own

## Indications for use
The Novel Spinal System is a 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 Novel Spinal 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/K081153
Methodology: https://510kreport.com/methodology