# K042702: Silhouette Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Zimmer Spine, Inc.
- Decided: Nov 23, 2004 after 54 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 1 generation back to K980288 (1998). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 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.

## Most influential descendants
- K111301: Instinct Java System (2011), 3 descendants of its own
- K113270: Instinct Java System (2011), 2 descendants of its own
- K123552: Instinct Java System (2013), 0 descendants of its own
- K122592: Instinct Java System (2013), 0 descendants of its own

## Indications for use
The SilhouetteTM Spinal System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture and dislocation); spinal stenosis; deformities (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients. 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 SilhouetteTM 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 the hook and sacral screw fixation of this system are T1 to the sacrum.

Source page: https://510kreport.com/device/K042702
Methodology: https://510kreport.com/methodology