# K020196: Modification to Silhouette Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Sulzer Spine-Tech
- Decided: Feb 15, 2002 after 24 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: 2 generations back to K980288 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980288: Spine-Tech Silhouette Spinal Fixation System, Spine-Tech, Inc. (1998) Summary page 1.
- K992276: Modification to Silhouette Spinal Fixation System, Sulzer Spine-Tech (1999) Summary page 1.

## Indications for use
When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). in addition, when used as a pedicle screw fixation system, the Silhouette Spinal Fixation System is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint b) who are receiving fusions with autogenous graft only c) who are having the device fixed or attached to the lumbar or sacral spine d) who are having the device removed after the development of a solid fusion mass When used as a hook and sacral screw system, the Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

Source page: https://510kreport.com/device/K020196
Methodology: https://510kreport.com/methodology