# K181591: Fixated Asfora BULLET CAGE® (FABC)

- Pathway: 510(k) (Traditional)
- Applicant: Medical Designs, LLC
- Decided: Sep 26, 2018 after 100 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: 19 generations back to K841189 (1984). 213 ancestors in all.
No later device cites it as a predicate yet.
1 of 214 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140106: S128 Anterior Lumbar Interbody Fusion (Alif) System, Renovis Surgical Technologies, Inc. (2014) Summary page 4.
- K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System, Ldr Spine USA (2016) Summary page 4.
- K090048: Asfora Bullet Cage System, Medical Designs, LLC (2009) Summary page 4.
- K112648: Asfora Bullet Cage, Medical Designs, LLC (2012) Summary page 4.
- K101301: Stalif Midline, Centinel Spine (2010) Summary page 4.
- K043479: MC+ Partial VBR, Ldr Spine USA (2005) Summary page 4.
- K024364: Synthes Vertebral Spacer TI (Curved and Narrow), Synthes (Usa) (2003) Summary page 4.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.
- K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System, Stryker Corporation (2015) Summary page 4.
- K113561: TM Ardis Interbody System TM Ardis Interbody System Instrumenation, Zimmer Trabecular Metal Technology (2012) Summary page 4.

## Indications for use
The Fixated Asfora BULLET CAGE® (FABC) is indicated for spinal fusion procedures in skeletally mature patients for the treatment of degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The FABC devices are used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. When used with the two fixation screws, the FABC System is a stand-alone system and requires no additional supplemental fixation. When used without the fixation screws, the FABC System should be used with supplemental fixation cleared for use in the lumbar spine. When only one device is implanted, the FABC System must be used with supplemental fixation cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K181591
Methodology: https://510kreport.com/methodology