# K240392: JAZZ Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Implanet
- Decided: May 6, 2024 after 88 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: 20 generations back to K040583 (2004). 369 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 371 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230961: Zeus Spinal System, Shanghai Sanyou Medical Co, Ltd. (2023) Summary page 5.
- K152781: Adena-Zina System, Shanghai Sanyou Medical Co, Ltd. (2016) Summary page 5.
- K182771: ISS-JAZZ Screw System and JAZZ CAP SP, Implanet, S.A. (2019) Summary page 5.
- K143731: IMPLANET Spine System (ISS), Implanet, S.A. (2015) Summary page 5.

## Most influential descendants
- K252437: JAZZ Spinal System (2025), 0 descendants of its own

## Indications for use
The JAZZ Spinal System is intended for posterior, non - cervical fixation as an adjunct to fusion for skeletally mature patients 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; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. In addition, when used as a pedicle screw fixation system, the JAZZ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar‐first sacral, L5‐S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K240392
Methodology: https://510kreport.com/methodology