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When used as an intervertebral body fusion device, the PILLAR™ Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous nonfusion surgery at the involved level(s).
The PILLAR™ Spacer System is intended for use with autograft and supplemental internal fixation. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System.

The PILLAR™ PL spacer is used singly or in pairs, and is implanted using a posterior approach.

The PILLAR™ TL spacer is used singly or in pairs, and is implanted using a transforaminal approach.

The PILLAR™ AL spacer is used singly, and is implanted using an anterior approach.

The PILLAR™ XL spacer is used singly, and is implanted using a lateral approach.

When used as a Partial Vertebral Body Replacement (VBR) System, the PILLAR™ Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.c., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR™ Spacer System 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 of time. The Partial VBR device is intended to be used with autograft or allograft.

The PILLAR™ Spacer System is intended for use with internal fixation. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

The PILLAR™ XL PEEK Spacers consist of a variety of implants manufactured from PEEK-OPTIMA® I.T (Polyetheretherketone), as described by ASTM F-2026, with Tantalum markers as described by ASTM F-560. The implants are available in a variety of footprint sizes. Additionally, they are offered in parallel and lordotic profiles in order to restore the natural curvature of the spine. The implants are available in various heights, in one millimeter increments. The superior and inferior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.

The PILLAR XL PEEK Spacers are intended for intervertebral body fusion or partial vertebral body replacement to aid in the surgical correction and stabilization of the spine,

The PILLAR XL PEEK Spacer components are not intended to be used as stand-alone devices. The PILLAR XI. PEEK Spacers must be used with supplemental internal fixation and are provided non-sterile.

This 510(k) premarket notification for the Blackstone PILLAR Spacer System Modification Confidential does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document is a standard 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on mechanical performance evaluations and equivalence in configuration, indications for use, and fundamental scientific technology. It does not describe performance acceptance criteria or a study that rigorously tests the device's performance against such criteria.

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