# K063393: Small Stature Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: Jun 25, 2007 after 228 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: 1 generation back to K061016 (2006). 1 ancestor in all.
493 later devices descend from it; 1 cites it directly.
1 of 495 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061016: Ebi Esl Peek-Optima Spine System, Ebi, L.P. (2006) 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 Small Stature Spacers are indicated for use in the thoracolumbar spine (i.e., T1 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 Small Stature Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Small Stature 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.

Source page: https://510kreport.com/device/K063393
Methodology: https://510kreport.com/methodology