(112 days)
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.