# K060009: Abbott Spine Universal Clamp System

- Pathway: 510(k) (Special)
- Applicant: Abbott Spine, Inc.
- Decided: Mar 6, 2006 after 62 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: 2 generations back to K925812 (1993). 2 ancestors in all.
48 later devices descend from it; 8 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)
- K974020: Spinal Concepts, Inc., Cfix Cable System, Spinal Concepts, Inc. (1997) Summary page 4.

## Most influential descendants
- 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
- K112736: Pass LP Spinal (2012), 25 descendants of its own

## Indications for use
The Universal Clamp System is a temporary implant 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 factures. The indications for use include, but are not limited to, the following applications: 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis, spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions; The Universal Clamp System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K060009
Methodology: https://510kreport.com/methodology