# K191217: Jazz PF

- Pathway: 510(k) (Traditional)
- Applicant: Implanet, S.A.
- Decided: Aug 2, 2019 after 88 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: 16 generations back to K040583 (2004). 162 ancestors in all.
No later device cites it as a predicate yet.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173117: NuVasive® VersaTie™ System, Nuvasive, Inc. (2017) Summary page 4.
- K182771: ISS-JAZZ Screw System and JAZZ CAP SP, Implanet, S.A. (2019) Summary page 4.

## Indications for use
The JAZZ systems (including the JAZZ Claw Connector) are temporary implants to be used in orthopedic surgery. The JAZZ systems are 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 Systems 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/K191217
Methodology: https://510kreport.com/methodology