# K183092: Kuros TLIF Cage

- Pathway: 510(k) (Traditional)
- Applicant: Kuros Biosciences B.V
- Decided: Mar 8, 2019 after 121 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- 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)
- K153783: SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF, Spinevision S.A. (2016) Summary page 5.
- K130573: Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif, Tyber Medical, LLC (2013) Summary page 5.
- K182746: ATEC ALIF and LLIF Spacer System, Alphatec Spine, Inc. (2018). Cleared while this submission was under review Summary page 5.
- K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 5.

## Indications for use
The Kuros TLIF Cage is intended for use in intervertebral body fusion of the spine. The Kuros TLIF cage is inserted via a posterior approach and can be used in one level or two contiguous levels of the lumbar spine (L1 to S1). The Kuros TLIF cage is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is to be used with supplemental posterior spinal fixation systems for use in the lumbar spine that are cleared by the FDA. The Kuros TLIF cage is intended for the treatment of patients with Degenerative Disk Disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must be skeletally mature and have had at least six months of non-operative treatment.

Source page: https://510kreport.com/device/K183092
Methodology: https://510kreport.com/methodology