Search Results

CONSTRUX Mini PTC Spacer System: The CONSTRUX Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The CONSTRUX Mini PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e., an anterior cervical plate such as the Orthofix Hallmark Anterior Cervical Plate System). Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.

FORZA PTC Spacer System: The FORZA PTC 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 non-fusion surgery at the involved levels. The FORZA Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g., the Firebird Spinal Fixation System. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA PTC Spacer System.

PILLAR SA PTC Spacer System: The PILLAR SA PTC 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 non-fusion surgery at the involved level(s). The PILLAR SA PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft. The PILLAR SA PTC Spacer System is intended for use with four of the titanium alloy screws provided with the system. If the physician chooses to use fewer than four of the provided screws then supplemental fixation must be used to augment stability. As an example, a supplemental fixation system that may be used is the Orthofix Firebird® Spinal Fixation System. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the PILLAR SA PTC Spacer System.

CONSTRUX Mini PTC Spacer System: The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants that has a PEEK core (conforming to ASTM F2026) with integrated porous Titanium alloy (Ti-6Al-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The titanium endplates have open macroscopic 3D pores with a microscopic roughened surface and nano-scale features. The CONSTRUX Mini PTC spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another. The CONSTRUX Mini PTC Spacer System is not intended to be used as a standalone device. The CONSTRUX Mini PTC Spacer System must be used with a supplemental fixation system. The CONSTRUX Mini PTC Spacer System implants are provided sterile.

FORZA PTC Spacer System: The FORZA PTC Spacer System is comprised of a variety of implants that have a PEEK core (conforming to ASTM F2026) with two integrated porous Titanium alloy (Ti-6Al-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The titanium endplates have open macroscopic 3D pores with a microscopic roughened surface and nano-scale features. The FORZA PTC Spacer System is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another. The FORZA PTC Spacer System is not intended to be used as a standalone device. The FORZA PTC Spacer System must be used with a supplemental fixation system. The FORZA PTC Spacer System implants are provided sterile.

PILLAR SA PTC Spacer System: The PILLAR SA PTC in a standalone intervertebral body implant that is comprised of a PEEK core (conforming to ASTM F2026) with integrated porous Titanium alloy (Ti-6Al-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The titanium endplates have open macroscopic 3D pores with a microscopic roughened surface and nano-scale features. The PILLAR SA PTC device is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another. The PILLAR SA PTC is designed to be used as a standalone device, when implanted with accompanying stabilizing screws. The PILLAR SA PTC spacers are provided sterile.

This document is a 510(k) premarket notification from the FDA, which serves to establish substantial equivalence of a new medical device to a legally marketed predicate device. This type of submission rarely contains the kind of detailed performance study results, acceptance criteria, and ground truth establishment methods typically associated with clinical trials or AI/algorithm-driven device evaluations.

The document states: "No new mechanical testing was performed for the CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System because there were no design changes to the device."

Instead, the submission is focused on adding "nanoscale descriptors to the labeling in accordance with the FDA Guidance Document 'Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.'" This suggests the primary focus of this specific 510(k) was to address regulatory labeling requirements related to nanotechnology features of the device rather than demonstrating a new performance claim through extensive testing.

The document does mention the following:

• "PTC nano-surface descriptors are supported by surface characterization and in vitro cellular studies using HMSCs and normal human osteoblasts (NHOst) cells."
• "The in vitro study results demonstrated that the PTC modified surface experienced an increased proliferation and alkaline phosphatase activity (an early osteogenic differentiation marker) in human stem cells compared to the other surfaces."

However, it does not provide quantitative acceptance criteria or detailed study methodologies that would allow for a table of acceptance criteria and reported device performance. It also doesn't discuss elements like sample size, data provenance, expert panels, adjudication, MRMC studies, or standalone algorithm performance, as these are not relevant to a 510(k) submission focused on labeling changes and demonstrating substantial equivalence to a previously cleared predicate device for a physical implant.

Therefore, I cannot provide the requested information. The document explicitly states that no new mechanical testing was performed due to no design changes, and the focus was on in vitro studies to support nanotechnology labeling. The information required for your request (e.g., acceptance criteria for clinical performance, sample sizes for a test set, expert involvement, MRMC studies) is typically found in submissions for devices making new performance claims or AI/ML-driven devices, not for a 510(k) focused on labeling for nanotechnology features of an already-cleared device design.

Ask a specific question about this device