# K151740: JAZZ System

- Pathway: 510(k) (Traditional)
- Applicant: Implanet, S.A.
- Decided: Aug 27, 2015 after 62 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: 10 generations back to K925812 (1993). 31 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142053: Universal Clamp Spinal Fixation System, Zimmer Spine, Inc. (2014) Summary page 4.
- K143759: JAZZ System, Implanet, S.A. (2015) Summary page 4.

## Most influential descendants
- K162764: Jazz Frame System (2017), 6 descendants of its own
- K170730: JAZZ System, including JAZZ Band (2017), 5 descendants of its own
- K222097: OLYMPIC Deformity Band System (2023), 3 descendants of its own
- K161265: NuVasive® VersaTie System (2016), 3 descendants of its own
- K231694: MASADA Modular Spinal Fixation System (2023), 2 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 or cobalt-chromium-molybdenum alloy whenever “wiring” may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K151740
Methodology: https://510kreport.com/methodology