# K061016: Ebi Esl Peek-Optima Spine System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Jun 8, 2006 after 56 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
525 later devices descend from it; 2 cite it directly.
1 of 526 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EBI® ESL® Spine Spacer System: named in the summary without a submission number
- (no number) Interpore Cross International PEEK CAS: named in the summary without a submission number

## Most influential descendants
- K063393: Small Stature Spacers (2007), 493 descendants of its own
- 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

## Indications for use
The ESL® PEEK-OPTIMA® is indicated for use in the thoracolumbar spine (i.e., Ti to 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® PEEK-OPTIMA® is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The ESL® PEEK-OPTIMA® 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.

Source page: https://510kreport.com/device/K061016
Methodology: https://510kreport.com/methodology