# K180990: TirboLOX-L Lumbar IBFD

- Pathway: 510(k) (Traditional)
- Applicant: Captiva Spine, Inc.
- Decided: Aug 13, 2018 after 119 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: 20 generations back to K841189 (1984). 291 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 293 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171351: Posterior Spine Truss System (PSTS) Interbody Fusion Device, 4Web, Inc. (2017) Summary page 4.
- K122956: Fuselox Lumbar Interbody Fusion Device, Captiva Spine (2012) Summary page 4.
- K150481: Cascadia Interbody System, K2m, Inc. (2015) Summary page 4.
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 4.
- K170341: Medussa-PL Cage, Medyssey USA, Inc. (2017) Summary page 4.
- K153400: ProLift Expandable System, Life Spine, Inc. (2016) Summary page 4.

## Most influential descendants
- K181229: TirboLOX-C Cervical IBFD (2018), 0 descendants of its own

## Indications for use
The Captiva Spine TirboLOX-L™ Lumbar IBFD is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocortical bone graft. The DDD patients may also have up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Source page: https://510kreport.com/device/K180990
Methodology: https://510kreport.com/methodology