Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
The purpose of this Post Market Surveillance Validation is to document the performance and
 clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity
 Correction System.
The purpose of this Post Market Surveillance Validation is to document the performance and
 clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity
 Correction System. We have extended the study tol collect further outcomes data at the 12
 month time point.
Inclusion Criteria:

 -  200 subjects at 10 clinical centers.

 -  All subjects undergoing spinal fusion surgery between the levels of T1- Ilium
 (Thoracic 1 to Ilium)

 -  All subjects are skeletally mature with spinal deformity.

 -  Risser score must be ≥ 3.

 -  Subjects or their representative must be willing and able to give informed consent and
 assent (if applicable).

 -  Subjects who do not meet any of the following contraindications: spinal infection or
 inflammation, morbid obesity, mental illness, alcoholism, drug abuse, pregnancy, metal
 sensitivity, foreign body sensitivity, patients with inadequate tissue coverage over
 the operative site, open wounds local to the operative area, any case not described in
 the specific indications

 Exclusion Criteria:

 -  Any subject who does not meet the inclusion criteria