# K180695: FBC 921 (Alif)

- Pathway: 510(k) (Traditional)
- Applicant: Fbc Device Aps
- Decided: Jul 12, 2018 after 118 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 17 generations back to K841189 (1984). 166 ancestors in all.
No later device cites it as a predicate yet.
1 of 167 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102738: Lanx Fusion System, Lanx, LLC (2011) Summary page 4.
- K123767: Lanx Fusion System- SA, Lanx, Inc. (2013) Summary page 4.
- K132790: Infix Anterior Lumbar System, Zimmer Spine, Inc. (2013) Summary page 4.
- K112316: 4-Web Alif Spinal Truss System (STS), 4-Web, Inc. (2011) Summary page 4.
- K142112: 4WEB Spinal Implant Products, 4Web, Inc. (2014) Summary page 4.
- K151214: ALIF Interfixated System, Nu Vasive, Incorporated (2015) Summary page 4.
- K150673: SYNFIX Evolution Secured Spacer System, Synthes (USA) Products, LLC (2015) Summary page 4.

## Indications for use
The FBC 921™ is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s) and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is intended to be used with posterior supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K180695
Methodology: https://510kreport.com/methodology