# K110348: Universal Clamp Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine
- Decided: Aug 11, 2011 after 185 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: 5 generations back to K925812 (1993). 25 ancestors in all.
44 later devices descend from it; 9 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091190: Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063, Zimmer Spine, Inc. (2009) Summary page 1.
- K081622: Universal Clamp Stainless Steel System, Abbott Spine, Inc. (2008) Summary page 1.
- K060009: Abbott Spine Universal Clamp System, Abbott Spine, Inc. (2006) Summary page 1.
- K962984: Isola Pediatric Components, Acromed Corp. (1996) Summary page 1.
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 1.
- K994121: Small Stature Uss, Synthes (Usa) (2000) Summary page 1.
- K913561: Luque Segmental Spinal Instrumentation, Zimmer, Inc. (1992) Summary page 1.

## Most influential descendants
- 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
- K132287: Jazz System (2013), 15 descendants of its own
- K133617: Jazz System (2014), 14 descendants of its own

## Indications for use
The Universal Clamp® Spinal Fixation 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 fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The Universal Clamp® Spinal 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/K110348
Methodology: https://510kreport.com/methodology