# K121541: Jazz System

- Pathway: 510(k) (Traditional)
- Applicant: Implanet, S.A.
- Decided: Sep 13, 2012 after 112 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: 6 generations back to K925812 (1993). 26 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 54 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.
- K081622: Universal Clamp Stainless Steel System, Abbott Spine, Inc. (2008)
- K110348: Universal Clamp Spinal Fixation System, Zimmer Spine (2011) Summary page 1.

## Most influential descendants
- K132287: Jazz System (2013), 15 descendants of its own
- K133617: Jazz System (2014), 14 descendants of its own
- K143759: JAZZ System (2015), 13 descendants of its own
- K151740: JAZZ System (2015), 12 descendants of its own
- K143350: Nile Alternative Fixation (2015), 10 descendants of its own

## Indications for use
The Jazz 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, 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 Jazz 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. The Jazz System is intended to be used with the CALYPSO pedicle screw system.

Source page: https://510kreport.com/device/K121541
Methodology: https://510kreport.com/methodology