# K143731: IMPLANET Spine System (ISS)

- Pathway: 510(k) (Traditional)
- Applicant: Implanet, S.A.
- Decided: Apr 14, 2015 after 106 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). 145 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120564: Calypso System, Hogan Lovells US LLP (2012) Summary page 4.
- K132303: Implanet Spine System, Implanet, S.A. (2013) Summary page 4.

## Most influential descendants
- K182771: ISS-JAZZ Screw System and JAZZ CAP SP (2019), 5 descendants of its own
- K240392: JAZZ Spinal System (2024), 1 descendant of its own
- K160226: JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector (2016), 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

## Indications for use
The IMPLANET Spine 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 IMPLANET Spine 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 lordlosis), tumor, pseudarthrosis, or revision of a failed fusion attempt. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine 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.

Source page: https://510kreport.com/device/K143731
Methodology: https://510kreport.com/methodology