# K181229: TirboLOX-C Cervical IBFD

- Pathway: 510(k) (Traditional)
- Applicant: Captiva Spine, Inc.
- Decided: Sep 19, 2018 after 133 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 21 generations back to K841189 (1984). 324 ancestors in all.
No later device cites it as a predicate yet.
1 of 325 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110585: Captiva Spine Fuselox Cervical Cage, Captiva Spine, Inc. (2011) Summary page 4.
- K180990: TirboLOX-L Lumbar IBFD, Captiva Spine, Inc. (2018). Cleared while this submission was under review Summary page 4.
- K150765: LDR Spine ROI-C Cervical Cage System, Ldr Spine USA (2015) Summary page 4.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 4.
- K153250: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System, Renovis Surgical Technologies (2016) Summary page 4.
- K120275: Synthes Acis/Vertebral Spacer CR, Synthes (Usa), LLC (2012) Summary page 4.
- K170550: Coveris Cervical Cage System, Camber Spine Technologies (2017) Summary page 4.

## Cited in the summary but kept off the family tree
- K125110: ROI-C. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4.

## Indications for use
The Captiva Spine TirboLOX-C™ Cervical IBFD is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one-disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Captiva Spine TirboLOX-C™ Cervical IBFD is used to facilitate fusion in the cervical spine and is placed via an anterior approach at the C3 to C7 disc levels with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

Source page: https://510kreport.com/device/K181229
Methodology: https://510kreport.com/methodology