# K090048: Asfora Bullet Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Designs, LLC
- Decided: Aug 14, 2009 after 219 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: 1 generation back to P950019 (1996). 2 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P970013: Microny Pacemakers, Abbott Medical (2000) Summary page 1.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.

## Most influential descendants
- K100820: Wenzel Spine Varilift Interbody Fusion System (2010), 16 descendants of its own
- K112648: Asfora Bullet Cage (2012), 14 descendants of its own
- K211873: PSX Interbody System (2021), 11 descendants of its own
- K222455: Calibrate LTX Interbody System (2022), 8 descendants of its own
- K151900: VariLift-L Interbody Fusion Device (2015), 8 descendants of its own

## Indications for use
The Asfora Bullet CageTM (ABC) is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two levels from L2 to S 1. The DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ABC cage devices are used with autogenous bone graft and are implanted via an open posterior approach. Patients should have had at least six (6) months of non-operative treatment prior to implant.

Source page: https://510kreport.com/device/K090048
Methodology: https://510kreport.com/methodology