# K132287: Jazz System

- Pathway: 510(k) (Traditional)
- Applicant: Hogan Lovells US LLP
- Decided: Sep 25, 2013 after 64 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: 7 generations back to K925812 (1993). 27 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110348: Universal Clamp Spinal Fixation System, Zimmer Spine (2011) Summary page 1.
- K121541: Jazz System, Implanet, S.A. (2012) Summary page 1.

## Most influential descendants
- 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
- K162764: Jazz Frame System (2017), 6 descendants of its own
- K170730: JAZZ System, including JAZZ Band (2017), 5 descendants of its own

## Indications for use
JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ 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 adolescent idiopathic scoliosis, adult scoliosis, kyphosis and 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 Implanet Spine System.

Source page: https://510kreport.com/device/K132287
Methodology: https://510kreport.com/methodology