# K980288: Spine-Tech Silhouette Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spine-Tech, Inc.
- Decided: Jul 29, 1998 after 184 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
959 later devices descend from it; 7 cite it directly.
1 of 960 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Depuy Motech MOSS Miami Spinal System: named in the summary without a submission number
- (no number) Sofamor Danek Multi Axial Screw: named in the summary without a submission number
- (no number) Sofamor Danek TSRII™ Spinal System: named in the summary without a submission number
- (no number) Wright Medical Technology Wrightlock™ Spinal System: named in the summary without a submission number
- (no number) Wright Medical Technology Versalok™ Low Back Fixation System: named in the summary without a submission number

## Most influential descendants
- K031511: Dynesys Spinal System (2004), 902 descendants of its own
- K050809: CD Horizon Spinal System (2005), 870 descendants of its own
- K043565: Modification to Dynesys Spinal System (2005), 834 descendants of its own
- K060615: CD Horizon Spinal System (2006), 822 descendants of its own
- K063670: Modifications to CD Horizon Spinal System (2007), 821 descendants of its own

## Indications for use
The Spine-Tech Sithouette Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joing b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of 2 solid fision mass. When used for this indication, the fusion mass may not go above the 1.5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum. When used as 2 hook and sacral screw system, the Spine-Tech Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic vrigin with degeneration of the disc confirmed by a 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 far this indication, screws of the Spine-Tech Silhouette Spinal Fixation System are intended for sacral/iliac attachment only. Hook and transverse comnectors 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/K980288
Methodology: https://510kreport.com/methodology