# K130641: Logic Stand-Alone Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Binder Biomedical, Inc.
- Decided: Sep 13, 2013 after 186 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: 11 generations back to K841189 (1984). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081395: Solitaire Peek-Optima Anterior Spinal System, Biomet Spine (2008)
- K120557: Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35, Biomet Spine & Bone Healing Technologies (2012)
- K093015: Binder Intervertebral Body Fusion Device, Binder Biomedical, Inc. (2010) Summary page 1.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 1.

## Indications for use
The LOGIC Stand-Alone Intervertebral Body Fusion Device is indicated for stand-alone intervertebral body fusion in patients with degenerative disc disease (ODD) at one (I1) or two (2) contiguous levels of the lumbasacral spine (L2-S 1). 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 LOGIC Stand-Alone Intervertebral Body Fusion Device is to be used with autogenous bone graft material.

Source page: https://510kreport.com/device/K130641
Methodology: https://510kreport.com/methodology