# K082406: Expandable Peek-Optima Implant

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Jan 14, 2009 after 146 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: 6 generations back to K010530 (2001). 11 ancestors in all.
527 later devices descend from it; 7 cite it directly.
1 of 539 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081636: Peek-Optima Alif Spacer, Biomet Spine (2008) Summary page 1.

## Most influential descendants
- K092336: C-Thru Spinal System (2009), 492 descendants of its own
- K100214: Cornerstone PSR Cervical Interbody Fusion Device (2010), 389 descendants of its own
- K111264: Cornerstone (R) PSR Cervical Fusion System (2011), 331 descendants of its own
- K112444: Anatomic Peek Cervical Fusion System (2011), 324 descendants of its own
- K122037: Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst (2013), 281 descendants of its own

## Indications for use
The Expandable PEEK-OPTIMA® Implant is indicated for vertebral body replacement. and intervertebral fusion. When used for vertebral body replacement, The Expandable PEEK-OPTIMA® Implant is indicated for use in the thoracolumbar spine (i.e., TI to L5) to replace 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 Expandable PEEK-OPTIMA® Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK-OPTIMA® Implant 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. As an intervertebral body fusion device, the Expandable PEEK-OPTIMA® Implant 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 1 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 Expandable PEEK-OPTIMA® Implant 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.

Source page: https://510kreport.com/device/K082406
Methodology: https://510kreport.com/methodology