# K093015: Binder Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Binder Biomedical, Inc.
- Decided: Feb 25, 2010 after 149 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy AcroMed, Inc. Lumbar I/F Cage with VSP Spine System: named in the summary without a submission number
- (no number) Globus Medical, Inc. PATRIOT Spacers: named in the summary without a submission number
- (no number) Lanx, Inc. Lanx Intervertebral Body Fusion Device: named in the summary without a submission number

## Most influential descendants
- K173864: Peekplus® Interbody Fusion Device (2018), 0 descendants of its own
- K130641: Logic Stand-Alone Intervertebral Body Fusion Device (2013), 0 descendants of its own

## Indications for use
The Binder Intervertebral Body Fusion Device ("Binder Fusion System") is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Binder Fusion devices are to be used with autogenous bone graft material and supplemental fixation.

Source page: https://510kreport.com/device/K093015
Methodology: https://510kreport.com/methodology