Search Results

The FORZA Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain 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. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The FORZA Spacer System is intended to be used with supplemental fixation systems. As an example, the supplemental fixation that may be used is the Orthofix Firebird Spinal Fixation System.

The FORZA Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

When used as an intervertebral body fusion device, the PILLAR PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The PILLAR PEEK Spacer System is intended to be used with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).

The PILLAR PL PEEK Spacer is used singly or in pairs and is implanted using a posterior approach.

The PILLAR TL PEEK Spacer is used singly or in pairs and is implanted using a transforaminal approach.

The PILLAR AL PEEK Spacer is used singly and is implanted using an anterior approach.

The PILALR XL PEEK Spacer is used singly and is implanted using a lateral approach.

The PILLAR PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

When used as a Partial Vertebral Body Replacement (VBR), The PILLAR PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord 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 PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of a fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.

The PILLAR PEEK Spacer System is intended for use with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).

When used as an intervertebral body fusion device, the PILLAR SA PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiquous levels from L2 to S1. These DDD patients may have up to Grade I Spondvlolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augmt stability. As an example, the supplemental fixation system that may be used is the Orthofix Spinal Fixation System (SFS).

The PILLAR SA PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

When used as a Partial Vertebral Body Replacement (VBR) the PILLAR SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., 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 SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR SA PEEK 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 PILLAR SA PEEK Spacer System is intended to be used with autograft or allograft.

The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. 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, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).

When used as an intervertebral body fusion device, the SKYHAWK Lateral Interbody Fusion Svstem is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with deqeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The SKYHAWK Lateral Interbody Fusion System is intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.

The SKYHAWK Lateral Interbody Fusion System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

The FORZA Spacer System consists of implants, trials, and instruments. The FORZA Spacer System is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK was utilized due to its radiolucent properties, which aids the surgeon in determining if fusion is the operative site has occurred. Since PEEK is transparent in x-rays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively.

The PILLAR Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with tantalum markers as described by ASTM F560. 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 either one or two millimeter increments. The superior and interior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.

The PILLAR Spacer System is intended for intervertebral body fusion or partial vertebral body replacement to aid in the surqical correction and stabilization of the spine.

The PILLAR Spacer System is not intended to be used as a stand-alone device. The PILLAR Spacer System must be used with supplemental internal fixation. The PILLAR Spacer System is provided non-sterile.

The PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with tantalum markers as described by ASTM F560. The implants are available in multiple footprint sizes, a variety of heights, and two angles of lordosis: 7° and 12°. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent movement of the device.

The PILLAR SA PEEK Spacer System is provided non-sterile.

The SKYHAWK Interbody Fusion System consists of implants, trials, and instruments. The system is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent properties, which aids the surgeon in determining if fusion is the operative site has occurred. Since PEEK is transparent in x-rays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively.

The SKYHAWK Interbody Fusion System implants are offered in parallel and lordotic profiles to restore the natural curvature of the spine; the device may be implanted using a later or anterolateral approach.

The SKYHAWK Interbody Fusion System implants, trials and instruments are provided nonsterile. They require sterilization prior to use.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document primarily focuses on demonstrating substantial equivalence to predicate devices for expanded indications for use.

Therefore, I cannot extract the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies from this document.

Ask a specific question about this device

The FORZATM 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 FORZATM Spacer System is intended for use with autograft and supplemental fixation system. As an example, the supplemental fixation system that may be used is the Orthofix Inc. Firebird™ Pedicle Screw System.

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

The FORZA Spacer System consists of implants, trials, and instruments. The FORZA Spacer System is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F-2026 with Tantalum markers as described by ASTM F-560. PEEK was utilized due to its radiolucent properties, which aids the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in x-rays, Tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively. The implants are offered in two geometric shapes: straight and curved, and offered in lordotic profiles to restore the natural curvature of the spine. Both the curved and straight implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA Spacer System is intended for intervertebral body fusion to aid in the surgical correction and stabilization of the spine.

The FORZA Spacer System is not intended to be used as a stand-alone device. The FORZA Spacer System must be used with supplemental fixation system. The FORZATM Spacer System implants are provided sterile. The FORZATM Spacer System trials and instruments are provided non-sterile.

The Orthofix Inc. FORZA™ Spacer System is an intervertebral body fusion device. The acceptance criteria and the study proving it meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• The document describes non-clinical mechanical testing.
• Sample Size for Test Set: Not explicitly stated as a number of devices/implants, but it refers to "mechanical testing of the Orthofix Inc. FORZATM Spacer System." The testing was conducted "in accordance to ASTM F2077-03 standard for Static & Dynamic Compression testing and ASTM F2267-04 standards for Subsidence testing." ASTM standards typically specify the number of samples required for such tests.
• Data Provenance: The data is generated from laboratory mechanical testing of the device itself. It is not patient data, thus, country of origin or retrospective/prospective designation are not applicable in this context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This information is not applicable as the ground truth for mechanical testing is established by adherence to universally accepted engineering standards (ASTM F2077-03 and ASTM F2267-04) and the physical properties of the materials and device design, not by expert human interpretation of medical data.

4. Adjudication Method for the Test Set

• This information is not applicable as the test set involves mechanical engineering tests against objective standards, not interpretation by human adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (intervertebral spacer) and relies on mechanical testing and comparison to predicate devices, not on a study with human readers interpreting imaging or clinical outcomes.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• This information is not applicable. This device is a physical implant, not an algorithm or a software device. Therefore, the concept of "standalone performance" in the context of AI algorithms does not apply.

7. The Type of Ground Truth Used

• The ground truth for the mechanical performance testing is established by objective engineering standards and specifications. Specifically, the device's performance was compared against the requirements and methodologies outlined in:
  • ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices) for Static and Dynamic Compression.
  • ASTM F2267-04 (Standard Test Method for Measuring the Compressive Properties of PEEK and Tantalum Markers) for Subsidence.
  • The "ground truth" for substantial equivalence is also derived from the established characteristics and performance of the identified predicate devices.

8. The Sample Size for the Training Set

• This information is not applicable as there is no "training set" in the context of a physical medical device submission based on mechanical testing and predicate device comparison. Device design and manufacturing processes are iteratively developed, but this is not analogous to an AI training set.

9. How the Ground Truth for the Training Set was Established

• This information is not applicable for the same reasons as #8.

Ask a specific question about this device