# K131540: Interfuse L Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Vertebral Technologies, Inc.
- Decided: Sep 3, 2013 after 97 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: 9 generations back to K841189 (1984). 38 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091988: Modification to: Interfuse Intervertebral Body Fusion Device , Model 9076, Vertebral Technologies, Inc. (2009) Summary page 1.
- K102277: Interfuse T Invertebral Body Fusion Device, Vertebral Technologies, Inc. (2010) Summary page 1.
- K123207: Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion System, Osteomed LP (2012) Summary page 1.

## Most influential descendants
- K160074: Rampart D Lumbar Interbody Fusion Device (2016), 5 descendants of its own
- K171660: Duo Lumbar Interbody Fusion Device (2017), 4 descendants of its own
- K181792: Duo™ Lumbar Interbody Fusion Device (2018), 3 descendants of its own
- K182322: Duo Lumbar Interbody Fusion Device (2018), 2 descendants of its own
- K190055: Duo Lumbar Interbody Fusion Device (2019), 1 descendant of its own

## Indications for use
The InterFuse L - Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse L device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse L device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.

Source page: https://510kreport.com/device/K131540
Methodology: https://510kreport.com/methodology