Search Results

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 or 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 (TI-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.

The Synthes Oracle Spacer is a radiolucent, oval-shaped interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. The Oracle Spacer implant may be used to accommodate the anatomical requirements of the intervertebral disc space. Pyramidal teeth that assist in further stabilization of the construct are located on the inferior and superior surfaces of the spacer. The open architecture of the device is intended to be packed with autogenous bone graft (i.e. autograft).

Synthes OPAL Spacer is a radiolucent, rectangular shaped interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. The OPAL Spacer construct is convex in shape to closely resemble patient anatomy and ensure accurate sizing. The implants have bulleted noses, and trial spacers facilitate self-distraction and insertion. The open architecture of the device is intended to be packed with autogenous bone graft (i.e. autograft).

The provided text describes two medical devices, the Synthes Oracle Spacer and the Synthes OPAL Spacer, and their clearance through the 510(k) pathway. It explicitly states in the "Performance Date (Non-Clinical and/or Clinical)" sections for both devices: "Clinical data and conclusions were not needed for this device."

Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set data can be extracted from this document, as no clinical studies were performed to demonstrate the device meets acceptance criteria. The clearance was based on substantial equivalence to a predicate device.

Ask a specific question about this device