(16 days)
Peridot-PT Anterior Cervical Intervertebral body fusion System: The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Perior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The Peridot-PT Anterior Cervical body fusion system is designed for use with autogenous and or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Peridot-PT Intervertebral body fusion system: The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The Peridot-TD Anterior Cervical Intervertebral body fusion system: The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Peridot-TD Intervertebral body fusion system: The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body fussion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system: The Peridot-PT Cages are a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665. The Peridot-PT Cages are made from Ti-6AI-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft comprised of Cancellous and/or corticocancellous bone graft. The hyperlordotic lumbar cages (>20 degree) the form of supplement fixation should be an anterior plate system.
The Peridot-TD Intervertebral body fusion system, The Peridot-TD Anterior Cervical Intervertebral body fusion system: This product is intervertebral fusion device manufactured from poly-ether-ether -ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The implants have a 0.5 ~ 1.0 micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cage holders are made of titanium alloy as per ASTM F136. The device have a central canal for receiving autogenous bone graft and offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. Designed to treat cervical and lumbar degenerative disc disease, the platform consists of Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. Tantalum marker on the cage permits the identification of cage position and allows post-operative assessment. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are intended to be used with supplement spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665. The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system. The device is supplied with their specific instrument. The device must be used in combination with the dedicated instrument supplied. The specific instrument is supplied dedicated tray and non-sterile.
The provided text describes a 510(k) premarket notification for various intervertebral body fusion systems. It outlines the device identification, indications for use, comparison to predicate devices, and performance testing. However, it does not contain specific acceptance criteria, reported device performance values, details of a study proving compliance, sample sizes for test or training sets, data provenance, information on expert ground truth establishment, adjudication methods, or MRMC study results.
The "Performance Testing" section lists the types of mechanical tests performed according to ASTM standards for static compression, shear, torsion, and fatigue, as well as subsidence and wear. It states that "The worst-case devices were tested," but does not provide any results from these tests or the acceptance criteria used to evaluate them.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other numbered questions related to study details, as this information is not present in the provided document.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices (K232822 and K233084) based on similar indications for use, technological characteristics (materials, design principles), and the use of established ASTM mechanical testing standards. The conclusion explicitly states: "Based on the information provided in this premarket notification... concludes that Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system, The Peridot-TD Intervertebral body fusion system, The Peridot-TD Anterior Cervical Intervertebral body fusion system are substantially equivalent to predicate devices." This implies that the device meets the same performance benchmarks as the predicate devices, but the specific numerical targets and results are not disclosed in this summary.
§ 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.