# K974020: Spinal Concepts, Inc., Cfix Cable System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Dec 19, 1997 after 58 days
- Product code: JDQ (Cerclage, Fixation)
- 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: 1 generation back to K925812 (1993). 1 ancestor in all.
49 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925812: Titanium Songer Cable System, Sofamor Danek Mfg., Inc. (1993) Summary page 1.

## Most influential descendants
- K060009: Abbott Spine Universal Clamp System (2006), 48 descendants of its own
- K081622: Universal Clamp Stainless Steel System (2008), 46 descendants of its own
- K091190: Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063 (2009), 45 descendants of its own
- K110348: Universal Clamp Spinal Fixation System (2011), 44 descendants of its own
- K121541: Jazz System (2012), 27 descendants of its own

## Indications for use
The Spinal Concepts, Inc. (SCI™) CFIX™ Cable System is a temporary implant for use in orthopedic and cardiovascular 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, but are not limited to 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 scoliosis, kyphosis, spondylolisthesis, etc.; Spinal degenerative surgery, as an adjunct to spinal fusions; Orthopedic trauma surgery, to secure fractures of the olecranon, patella, femur, humerus, etc. Cables may also be used to reduce and secure dislocations of the acromioclavicular joint; Orthopaedic reconstructive surgery, to reattach the greater trochanter after trochanteric osteotomy during total hip arthroplasty; Cardiovascular surgery for closure of the sternum following sternotomy; and Oral surgery, to repair and fix fractures of the mandible and other facial fractures. The CFIX™ Cable System may also be used in conjunction with other medical implant grade implants made of titanium alloy (e.g. Luque rods) whenever “wiring” may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K974020
Methodology: https://510kreport.com/methodology