# K160226: JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector

- Pathway: 510(k) (Traditional)
- Applicant: Implanet, S.A.
- Decided: May 18, 2016 after 110 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K040583 (2004). 160 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151740: JAZZ System, Implanet, S.A. (2015) Summary page 5.
- K143731: IMPLANET Spine System (ISS), Implanet, S.A. (2015) Summary page 5.
- K030377: Modification to Synthes Cervifix System, Synthes (Usa) (2003) Summary page 5.

## Most influential descendants
- K171881: JAZZ Passer Band (2017), 0 descendants of its own

## Indications for use
The JAZZ CLAW System (hooks and rods) is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Jazz Claw System (hooks and rods) is intended for posterior fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (fracture or dislocation); spinal stenosis; spinal deformities (scoliosis, kyphosis and/or lordlosis) tumor; pseudarthrosis; and revision of a failed fusion attempt. The Jazz Claw System (hooks and rods) is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. The JAZZ CLAW connector consists of temporary implants to be used in orthopedic surgery. The JAZZ CLAW connector 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; 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 CLAW connector 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/K160226
Methodology: https://510kreport.com/methodology