# K092574: Esl Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Feb 4, 2010 after 167 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: 7 generations back to K010530 (2001). 13 ancestors in all.
181 later devices descend from it; 3 cite it directly.
0 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040928: Expandable Peek VBR Implant, Interpore Cross Intl. (2004) Summary page 1.
- K082406: Expandable Peek-Optima Implant, Ebi, L.P. (2009) Summary page 1.
- K061016: Ebi Esl Peek-Optima Spine System, Ebi, L.P. (2006) Summary page 1.

## Most influential descendants
- K110650: Zyston Arc Interbody Spacer (2011), 177 descendants of its own
- K112014: Zyston Straight Spacer System (2011), 174 descendants of its own
- 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

## Indications for use
The ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal 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 ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal 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. As an intervertebral body fusion device, the ESL® Spinal 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 ESL® Spinal 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 ESL® Spinal 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/K092574
Methodology: https://510kreport.com/methodology