# K112014: Zyston Straight Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: Oct 17, 2011 after 95 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: 8 generations back to K003155 (2001). 44 ancestors in all.
174 later devices descend from it; 2 cite it directly.
0 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091381: Ibex Spinal System, Ebi, L.P. (2009) Summary page 2.
- K050861: Peek Cas, Interpore Cross Intl. (2005) Summary page 2.
- 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.
- K080699: Novel Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 2.
- K050624: Stryker Spine Avs PL Peek Spacer, Stryker Spine (2005) Summary page 2.
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 2.
- K082014: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2008) Summary page 2.

## Most influential descendants
- K122989: Biomet Lateral Spacer System (2012), 171 descendants of its own
- 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

## Indications for use
The Zyston Straight Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Zyston Straight Spacer System is indicated for use in the thoracolumbar spine (i.e., T1 - 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 Zyston Straight Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Zyston Straight Spacer System is designed to restore the biomechanical 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 Zyston Straight 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 Zyston Straight Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 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 Zyston Straight 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 Zyston Straight Spacer System may also be implanted using the AccuVision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

Source page: https://510kreport.com/device/K112014
Methodology: https://510kreport.com/methodology