# K092336: C-Thru Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Oct 15, 2009 after 72 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
Longest line of descent: 7 generations back to K010530 (2001). 15 ancestors in all.
492 later devices descend from it; 7 cite it directly.
1 of 508 devices in its family (counting itself) has 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.
- K081730: Novel Cervical Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 1.
- K063393: Small Stature Spacers, Biomet Spine (2007) Summary page 1.

## Most influential descendants
- 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
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (2015), 228 descendants of its own

## Indications for use
The C-ThruTM Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used as a vertebral body replacement device, the C-ThruTM Spacers are 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 C-ThruTM Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The C-ThruTM Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a cervical intervertebral fusion device, the C-Thru Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to Ti) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The C-Thru Spacers are intended for use with supplemental fixation and autogenous bone graft to facilitate the fusion.

Source page: https://510kreport.com/device/K092336
Methodology: https://510kreport.com/methodology