# K092011: Norm Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar
- Decided: Oct 28, 2009 after 114 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: 4 generations back to K000319 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063708: 4S Spinal System, Taeyeon Medical Co., Ltd. (2007) Summary page 1.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 1.

## Indications for use
NORM spinal system implants are designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following indications 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). Levels of fixation are for the thoracic, lumbar and sacral spine. Norm Posterior Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attachment of a solid fusion.

Source page: https://510kreport.com/device/K092011
Methodology: https://510kreport.com/methodology