# K072791: Oracle Spacer, Opal Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Dec 26, 2007 after 86 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P960025 (1999). 1 ancestor in all.
1,055 later devices descend from it; 29 cite it directly.
1 of 1,057 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.

## Most influential descendants
- K081177: Blackstone Medical, Inc., Pillar Spacer System (2008), 848 descendants of its own
- K111512: Bonebac T-Plif Intervertebral Body Fusion Device System (2011), 762 descendants of its own
- K120368: Capstone Control Spinal System (2012), 761 descendants of its own
- K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device (2008), 753 descendants of its own
- K100043: Coroent XLR Standalone System (2010), 744 descendants of its own

## Recalls of this device
- Feb 18, 2016 · Class II · Z-1392-2016: The label on the outer packaging does not match the product inside and intended use of the device.

## Indications for use
Synthes Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Oracle Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. *The Oracle Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS (including Click’X) and small stature USS. Synthes 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. The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. *The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS (including Click’X) and small stature USS. The OPAL Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to.replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The OPAL Spacer is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of the spacer component of the OPAL Spacer system can be packed with bone.

Source page: https://510kreport.com/device/K072791
Methodology: https://510kreport.com/methodology