# K110650: Zyston Arc Interbody Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine (Aka Ebi, LLC)
- Decided: Jun 30, 2011 after 118 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: 10 generations back to K841189 (1984). 41 ancestors in all.
177 later devices descend from it; 3 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.
- K082406: Expandable Peek-Optima Implant, Ebi, L.P. (2009) Summary page 2.
- K092574: Esl Spinal System, Ebi, L.P. (2010) Summary page 2.
- K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 2.
- K080401: Shell Cage, Wave Cage, Loop Cage, Advanced Medical Technologies AG (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 Curve Interbody 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. The Zyston Curve Interbody 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 Curve Interbody 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/K110650
Methodology: https://510kreport.com/methodology