# K182771: ISS-JAZZ Screw System and JAZZ CAP SP

- Pathway: 510(k) (Traditional)
- Applicant: Implanet, S.A.
- Decided: Mar 12, 2019 after 165 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). 146 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143731: IMPLANET Spine System (ISS), Implanet, S.A. (2015) Summary page 4.

## Most influential descendants
- K240392: JAZZ Spinal System (2024), 1 descendant of its own
- K252437: JAZZ Spinal System (2025), 0 descendants of its own
- K230565: HILINE™ Fixation System (2023), 0 descendants of its own
- K201240: Mariner Cap System (2020), 0 descendants of its own
- K191217: Jazz PF (2019), 0 descendants of its own

## Indications for use
The ISS-JAZZ Screw System 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 ISS-JAZZ Screw System is intended for posterior, non-cervical pedicle and non-pedicle 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 (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ISS-JAZZ Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. 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; 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/K182771
Methodology: https://510kreport.com/methodology