# K122989: Biomet Lateral Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine (Aka Ebi, LLC)
- Decided: Oct 24, 2012 after 28 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). 77 ancestors in all.
171 later devices descend from it; 2 cite it directly.
0 of 249 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082406: Expandable Peek-Optima Implant, Ebi, L.P. (2009) Summary page 2.
- K040928: Expandable Peek VBR Implant, Interpore Cross Intl. (2004) Summary page 2.
- K092574: Esl Spinal System, Ebi, L.P. (2010) Summary page 2.
- K040482: Ebi Esl Spine Spacer System, Ebi, L.P. (2004) Summary page 2.
- K112014: Zyston Straight Spacer System, Biomet Spine (2011)
- K110650: Zyston Arc Interbody Spacer, Biomet Spine (Aka Ebi, LLC) (2011)
- K083026: Clydesdale Spinal System, Medtronic Sofamor Danek (2008) Summary page 2.
- K113528: Clydesdale (R) Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 2.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 2.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 2.
- K082128: Depuy Spine Lateral Cage System, Depuy Spine (2008) Summary page 2.
- K090899: Depuy Spine Lateral System, Depuy Spine, Inc. (2009) Summary page 2.

## Most influential descendants
- K151310: Amendia Interbody Fusion Devices (2016), 169 descendants of its own
- K160924: Amendia Interbody Fusion Devices (2016), 166 descendants of its own
- K171496: Tritanium C Anterior Cervical Cage (2017), 129 descendants of its own
- K180364: HD LifeSciences Cervical IBFD System (2018), 106 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own

## Indications for use
The Biomet Lateral Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Biomet Lateral Spacer System is indicated for use in the thoracolumbar spine (i.e., TI- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Biomet Lateral Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet Lateral Spacer System is designed to restore the biomnechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Biomet Lateral Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine. As an intervertebral body fusion device, the Biomet Lateral Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI in patients with degenerative disc-disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the Biomet Lateral Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Biomet Lateral Spacer System may be implanted via an open or minimally invasive lateral approach.

Source page: https://510kreport.com/device/K122989
Methodology: https://510kreport.com/methodology