# K081622: Universal Clamp Stainless Steel System

- Pathway: 510(k) (Special)
- Applicant: Abbott Spine, Inc.
- Decided: Aug 29, 2008 after 80 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: 3 generations back to K925812 (1993). 3 ancestors in all.
46 later devices descend from it; 4 cite it directly.
0 of 50 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 2.

## Most influential descendants
- 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
- K142053: Universal Clamp Spinal Fixation System (2014), 23 descendants of its own
- K132395: Ligapass (2013), 23 descendants of its own

## Indications for use
The Universal Clamp Stainless Steel 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 Stainless Steel System may also be used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K081622
Methodology: https://510kreport.com/methodology