(60 days)
The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 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. These implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
The CAPSTONE PTC™ Spinal System is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 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. Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.
The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 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. These implants are to be used autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with supplementation which has been cleared by the FDA for use in the lumbar spine.
The CRESCENT™ Spinal System Titanium is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 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. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
The subject ELEVATE™ Spinal System consists of bullet nose expandable cages with teeth. The top of the cage is made of Polyetheretherketone (PEEK) and the base is made of Titanium Alloy (Ti-6Al-4V). The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The ELEVATE™ implants are provided in both standard and an extra-lordotic design. The devices can be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The implants also contain hollow geometry which allows them to be packed with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
The subject CAPSTONE PTC™ Spinal System consists of convex cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone (PEEK) and coated with Commercially Pure Titanium (CP Ti). The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The CAPSTONE PTC™ implants are provided in various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
The subject CRESCENT™ Spinal System consists of banana shaped cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone (PEEK) and contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The CRESCENT™ implants are provided in various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
The subject CRESCENT™ Spinal System Titanium consists of banana shaped cages with a bullet nose and angular teeth. The CRESCENT™ Titanium implants are made of Titanium Alloy (Ti-6Al-4V) and are provided in various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
I am sorry, but based on the provided document, there is no information about acceptance criteria and a study that proves the device meets those criteria. The document is a 510(k) premarket notification for an intervertebral body fusion device, and it primarily focuses on establishing substantial equivalence to previously cleared predicate devices.
The key points from the document regarding "testing" are:
- Bacterial Endotoxin Test (LAL test): This was performed on worst-case subject implants to verify they meet the 20 endotoxin units (EU)/device pyrogen limit specification, as outlined in ANSI/AAMI ST72 and USP . This is a non-clinical test related to sterility and safety, not a performance study of the device's clinical efficacy.
- Retrospective Clinical Data: The document mentions published retrospective clinical data for lumbar interbody fusion devices cleared in K151128 (CAPSTONE® and CLYDESDALE® Spinal System). This data demonstrated that the use of allogenic bone graft (with or without autogenous bone graft) is commonly used and poses no new risks. However, this is not a study specifically assessing the performance or acceptance criteria of the current devices (ELEVATE™, CAPSTONE PTC™, CRESCENT™, CRESCENT™ Titanium) against specific metrics. Instead, it supports the expansion of indications for use to include allogenic bone graft as an option, based on existing clinical practice and prior clearances.
Therefore, I cannot provide the requested table or details about a study proving the device meets acceptance criteria, an MRMC study, standalone algorithm performance, or ground truth establishment relevant to clinical performance, as this information is not present in the provided text.
§ 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.