# K103147: Novel Iii Spinal Fixation and Adjustable Bridge System

- Pathway: 510(k) (Special)
- Applicant: Medyssey Co, Ltd.
- Decided: Dec 16, 2010 after 52 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). 6 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K110284: Novel Iii Spinal Fixation and Adjustable Bridge System (2011), 12 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
- 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

## Indications for use
The Novel Ill Spinal System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L-5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L-3 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/K103147
Methodology: https://510kreport.com/methodology