# K053070: Contour II Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Altiva Corp.
- Decided: Feb 13, 2006 after 104 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 K000319 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971457: Bryan Posterior Spinal Fixator (BPSF), Modified, Arcan Orthopaedic Corp. (1997) Summary page 4.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 4.
- K962784: Ultium Spinal Plating System, Smith & Nephew, Inc., Orthopaedic Div. (1996) Summary page 4.

## Indications for use
The CONTOUR IITM Spinal System is intended for noncervical, pedicle fixation 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, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). In addition, the CONTOUR IITM Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion. The CONTOUR IITM Spinal System (KWP) is also intended for use as a posterior noncervical, ilonpedicle system indicated for degenerative disc disease which is defined as back pain of dicogeilic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthosis, or revision of failed fusion attempts. When used as an anterior fixation system, the CONTOUR IITM Spinal System (KWQ) is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history .and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthosis, or revision of failed fusion attempts.

Source page: https://510kreport.com/device/K053070
Methodology: https://510kreport.com/methodology