# K062933: Synthes Oracle Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine Co.Lp
- Decided: Jan 31, 2007 after 125 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 K010530 (2001). 2 ancestors in all.
600 later devices descend from it; 2 cite it directly.
1 of 603 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011037: Vertebral Spacer, Synthes (Usa) (2002) Summary page 1.
- K010530: Geo Structure, Interpore Cross Intl. (2001) Summary page 1.

## Most influential descendants
- K131082: Interform Interbody Cage System (2013), 595 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 descendants of its own
- K153419: NuVasive CoRoent Thoracolumbar System (2016), 400 descendants of its own

## Indications for use
The Oracle Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures for the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Oracle Spacer is intended to be used with Synthes internal fixation systems, e.g., Pangea, USS (including Click'X), Small Stature USS, ATLP, TSLP, and Ventrofix. The interior of the spacer can be packed with bone (autograft or allograft). The Oracle Spacer 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/K062933
Methodology: https://510kreport.com/methodology