# K992276: Modification to Silhouette Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Spine-Tech
- Decided: Oct 1, 1999 after 86 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 1 generation back to K980288 (1998). 1 ancestor in all.
171 later devices descend from it; 4 cite it directly.
0 of 173 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
- K993067: Silhouette Spinal Fixation System (1999), 111 descendants of its own
- K072022: Valeo Pedicle Screw Spinal System (2007), 100 descendants of its own
- K022374: Cadence Spinal Fixation System (2002), 84 descendants of its own
- K041925: ST360 Spinal Fixation System (2004), 83 descendants of its own
- K121115: M.U.S.T Pedicle Screw System (2012), 43 descendants of its own

## 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/K992276
Methodology: https://510kreport.com/methodology