# K200235: KONG-TL VBR System, KONG-C VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: May 29, 2020 after 120 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: 23 generations back to K841189 (1984). 318 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 320 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191778: Omnia Medical VBR, Omnia Medical, LLC (2019) Summary page 5.
- K180550: NuVasive Monolith Cervical Corpectomy System, Nu Vasive, Incorporated (2018) Summary page 5.
- K192117: Small VBR™, Ulrich GmbH & Co. KG (2019) Summary page 5.
- K181921: Solidity Vertebral Body Replacement, Ulrich Medical USA (2018) Summary page 5.
- K180665: SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System, K2m, LLC (2018) Summary page 5.
- K060416: Obelisc Vertebral Body Replacement Device, Ulrich GmbH & Co. KG (2006) Summary page 5.
- K103320: Synthes XRL, Synthes Spine Co.Lp (2011) Summary page 5.

## Most influential descendants
- K232790: KONG®-TL VBR System and KONG® C VBR System (2024), 0 descendants of its own

## Indications for use
Cervical 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 corticocancellous 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. Thoracolumbar 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 corticocancellous 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.

Source page: https://510kreport.com/device/K200235
Methodology: https://510kreport.com/methodology