# K133482: Silc Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: May 21, 2014 after 189 days
- Product code: OWI (Bone Fixation Cerclage, Sublaminar)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K925812 (1993). 28 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060009: Abbott Spine Universal Clamp System, Abbott Spine, Inc. (2006) Summary page 1.
- K110348: Universal Clamp Spinal Fixation System, Zimmer Spine (2011) Summary page 1.
- K112736: Pass LP Spinal, Medicrea International (2012) Summary page 1.
- K922952: Songer Cable System, Pioneer Surgical Technology (1993) Summary page 1.

## Most influential descendants
- K143350: Nile Alternative Fixation (2015), 10 descendants of its own
- K161332: NILE Proximal Fixation Spinal System (2017), 5 descendants of its own
- K160208: NILE Alternative Fixation Spinal System (2016), 5 descendants of its own
- K222684: XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (2023), 4 descendants of its own
- K163181: TRANSLACE™ Spinal Tethering System (2017), 2 descendants of its own

## Indications for use
The SILCTM Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: * Spinal trauma surgery, used in sublaminar, interspinous or facet wiring techniques; * Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scaliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; * Spinal degenerative surgery, as an adjunct to spinal fusions. The SILCTh Fixation System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring" may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K133482
Methodology: https://510kreport.com/methodology