# K151483: Biomet Spine Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine, LLC
- Decided: Jul 31, 2015 after 59 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: 12 generations back to K841189 (1984). 44 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142634: Biomet Spine Fusion System, Biomet Spine, LLC (2015) Summary page 4.
- K081968: Modification to Lucent, Spinal Elements, Inc. (2008) Summary page 4.

## Most influential descendants
- K153695: Biomet Spine Fusion System (2016), 3 descendants of its own
- K171495: Zyston Strut Open Titanium Spacer System (2018), 1 descendant of its own
- K251479: Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) (2025), 0 descendants of its own
- K181096: Avenue P Cage System (2019), 0 descendants of its own

## Indications for use
When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spine Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement

Source page: https://510kreport.com/device/K151483
Methodology: https://510kreport.com/methodology