# K171881: JAZZ Passer Band

- Pathway: 510(k) (Traditional)
- Applicant: Implanet, S.A.
- Decided: Aug 8, 2017 after 46 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). 174 ancestors in all.
No later device cites it as a predicate yet.
0 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170730: JAZZ System, including JAZZ Band, Implanet, S.A. (2017) Summary page 5.
- K162764: Jazz Frame System, Implanet, S.A. (2017) Summary page 5.
- K153348: Jazz Lock, Implanet, S.A. (2016) Summary page 5.
- K160226: JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector, Implanet, S.A. (2016) Summary page 5.
- K151740: JAZZ System, Implanet, S.A. (2015) Summary page 5.

## Indications for use
The Jazz Systems 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/K171881
Methodology: https://510kreport.com/methodology