# K162764: Jazz Frame System

- Pathway: 510(k) (Traditional)
- Applicant: Implanet, S.A.
- Decided: Jan 19, 2017 after 111 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: 14 generations back to K040583 (2004). 166 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132303: Implanet Spine System, Implanet, S.A. (2013) Summary page 4.
- K151740: JAZZ System, Implanet, S.A. (2015) Summary page 4.
- K101682: S 100 Pedicle Screw System, Renovis Surgical Technologies, LLC (2010) Summary page 4.
- K111940: S 100 Pedicle Screw System, Renovis Surgical Technologies, LLC (2012) Summary page 4.

## Most influential descendants
- K170730: JAZZ System, including JAZZ Band (2017), 5 descendants of its own
- K222097: OLYMPIC Deformity Band System (2023), 3 descendants of its own
- K231694: MASADA Modular Spinal Fixation System (2023), 2 descendants of its own
- K252346: OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (2025), 0 descendants of its own
- K243259: MASADA Modular Spinal Fixation System (2025), 0 descendants of its own

## Indications for use
The Jazz Claw System (hooks and rods) and the Jazz Frame System are 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) and the Jazz Frame System are 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 (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis or revision of a failed fusion attempt. The Jazz Claw System (hooks and rods) and the Jazz Frame System 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.

Source page: https://510kreport.com/device/K162764
Methodology: https://510kreport.com/methodology