# K122956: Fuselox Lumbar Interbody Fusion Device

- Pathway: 510(k) (Special)
- Applicant: Captiva Spine
- Decided: Oct 25, 2012 after 30 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: 11 generations back to K841189 (1984). 53 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092017: Pivotec Lumbar Interbody Fusion Device (Lifd), Captiva Spine, Inc. (2009) Summary page 1.
- K113138: Aleutian System, K2m, Inc. (2012)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.

## Most influential descendants
- K180990: TirboLOX-L Lumbar IBFD (2018), 1 descendant of its own
- K181229: TirboLOX-C Cervical IBFD (2018), 0 descendants of its own

## Indications for use
The FuseLOX Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K122956
Methodology: https://510kreport.com/methodology