# K232790: KONG®-TL VBR System and KONG® C VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: Apr 4, 2024 after 206 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K841189 (1984). 319 ancestors in all.
No later device cites it as a predicate yet.
1 of 320 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200235: KONG-TL VBR System, KONG-C VBR System, Icotec AG (2020) Summary page 5.

## Indications for use
KONG®-TL VBR System KONG®-TL VBR System devices are intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). When used in the thoracolumbar spine, the KONG®-TL VBR System is intended to be used with FDA-cleared supplemental fixation appropriate for the implanted level, including icotec Pedicle Screw Systems. These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocortical bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion. When used with the VADER® Pedicle System, the KONG®-TL VBR System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression. KONG®-C VBR System KONG®-C VBR System devices are intended for use in the cervical spine (from C2 to T1) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. KONG®-C VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocortical bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion. When used with the icotec Anterior Cervical Plate System, the KONG®-C VBR System is intended to stabilize the cervical (from C2 to T1) spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

Source page: https://510kreport.com/device/K232790
Methodology: https://510kreport.com/methodology