(179 days)
The Vertebral Body Replacement (VBR) Spinal Systems are indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace 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 VBR Spinal Systems are also indicated for treating fractures of the thoracic and lumbar spine.
The VBR Spinal Systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The VBR Spinal Systems are intended for use with DePuy Spine supplemental internal fixation.
The BENGAL System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation products may be used.
The BENGAL System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. This 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. When used as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation products.
The CONCORDE, CONCORDE Inline, CONCORDE Curve, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF (CONCORDE, CONCORDE Inline) or TLIF (CONCORDE, CONCORDE Inline, CONCORDE Curve, DEVEX, LEOPARD) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.
The CONCORDE. CONCORDE Inline. CONCORDE Curve. DEVEX. and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace 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. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation products.
The CONCORDE Bullet and COUGAR Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally the CONCORDE Bullet and COUGAR Systems can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF or TLIF approach (CONCORDE Bullet) or an anterior approach (COUGAR) using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products.
The CONCORDE Bullet and COUGAR Systems are indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace 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. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation products.
The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. The 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. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation.
The COUGAR LS Lateral Cage System is also indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. Additionally, the COUGAR LS Lateral Cage System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six mon-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and may be implanted via an open or a minimally invasive lateral approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.
The DePuy PULSE Cervical Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. The DePuy PULSE Cervical Cage System implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. DePuy PULSE Cervical Cage System implants are intended to be used with supplemental internal fixation systems.
The DePuy PULSE Lumbar Cage System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a PLIF or TLIF approach using autogenous bone. When used as intervertebral body fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.
The Lumbar I/F Cage System is indicated for an open posterior approach using autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1 whose condition requires the use of interbody fusion combined with posterolateral fusion (360° fusion) and posterior pedicle screw fixation. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
The X-MESH Expandable Cage System is designed to restore biomechanical integrity throughout the thoracic and lumbar spine following vertebrectomy or corpectomy for patients with spine tumors or fractures. The system is available in many heights, and different endplate shapes, sizes and angles. The surgeons have the option to place the standard or angled endplates. The spikes on the endplates help anchor the device.
The OCELOT Stackable Cage System consists of one or more stackable vertebral body replacement components and a supplemental internal fixation system. One or more OCELOT Stackable Cage System implants may be stacked to the desired height, as determined by the surgeon. A titanium alloy screw can be passed through a center hole in the cages and with a nut provide a rigid and compressed assembly.
The Stackable Cage System is designed to restore biomechanical integrity throughout the thoracic and lumbar spine following vertebrectomy or corpectomy. A Stackable Cage construct consists of one or more cages that are stacked to the desired height, as determined by the surgeon. Ridges or teeth allow the cages to be assembled, and a locking screw and nut secure the components as a construct.
The Surgical Titanium Mesh System is designed to restore biomechanical integrity throughout the thoracic and lumbar spine following vertebrectomy or corpectomy for patients with spine tumors or fractures. The system consists of various shapes and sizes of mesh, standard or angled rings and screws, endplates, and endcaps. The surgeons have the option to place the standard or angled rings and screws, endplates and endcaps within the mesh. These interface devices may be used to provide increased surface area at the mesh/bone interface, which provides additional support and increased resistance to subsidence.
The BENGAL Stackable Cage System consists of both one piece (monolithic) and twoto three-piece (stackable) vertebral body replacement components and a supplemental internal fixation system that offer a variety of size options to allow surgeons to achieve a desired height. The two- or three-piece (stackable) construct can be assembled from a variety of different sized components. A titanium alloy screw is then passed through a hole in the cages and with a nut provides a rigid and compressed assembly.
The BENGAL, CONCORDE, CONCORDE Bullet, CONCORDE Inline, CONCORDE Curve, COUGAR, DEVEX and LEOPARD Systems consist of polymer/carbon fiber composite or titanium cages and implantation instrumentation. Cages are available in varying shape and size configurations to match patient anatomy. The polymer/carbon fiber cage structure is radiolucent with tantalum x-ray markers so that healing can be assessed by normal radiographic methods. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft.
The DePuy PULSE Cervical Cage System is designed for use as a cervical intervertebral body fusion device and consists of polymer cages and implantation instrumentation. The cages are available in various geometries and sizes to accommodate patient anatomy. The polymer cage structure is radiolucent with tantalum x-ray markers so that healing can be assessed by normal radiographic methods. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft.
The DePuy PULSE Lumbar Cage System is designed for use as a lumbar intervertebral body fusion device and consists of polymer cages and implantation instrumentation. The cages are available in various geometries and sizes to accommodate patient anatomy. The polymer cage structure is radiolucent with tantalum x-ray markers so that healing can be assessed by normal radiographic methods. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft.
The LUMBAR I/F CAGE is made of a polymer/carbon fiber composite material, is radiolucent, and available is two designs: the Jaguar I/F Cage and the Saber I/F Cage. The Jaguar I/F Cage is a rectangular cage with ridged teeth to resist implant pullout. The Saber I/F Cage, also a rectangular cage, has a curved lateral wall and rounded edges with pyramidal teeth to resist implant pullout. Each of these designs has both parallel and wedged configurations.
This document, a 510(k) summary, details the submission for clearance of magnetic resonance compatibility labeling for a multitude of spinal implant systems. It does not contain information about acceptance criteria or a study proving the device meets said criteria related to clinical efficacy or performance beyond MR compatibility. The document is primarily focused on demonstrating substantial equivalence to predicate devices and providing performance data for MR compatibility.
Here's an analysis based on the provided text for what is present regarding MR compatibility:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria and reported device performance in the format requested for general device performance. However, for MR compatibility, it refers to industry standards which implicitly contain acceptance criteria. The "Performance Data" section states that "Results demonstrated compatibility conditions of the subject devices in the MR environment," which serves as the reported performance, indicating the devices met the criteria defined by the listed ASTM standards.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set used for the MR compatibility studies. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. This is typical for preclinical testing data referenced in a 510(k) submission, where the focus is often on adherence to recognized standards rather than clinical trial details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable to the non-clinical MR compatibility testing described in the document. Ground truth as typically established by experts (e.g., radiologists interpreting images) is not relevant for in-vitro engineering tests like those for MR compatibility.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable to the non-clinical MR compatibility testing described in the document. Adjudication methods are relevant for clinical studies involving human interpretation or assessment, not for standardized engineering tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the document describes spinal implants (hardware), not an AI-powered diagnostic device or software. Therefore, no MRMC study or AI assistance is mentioned or relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the document describes spinal implants (hardware), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the MR compatibility testing, the "ground truth" would be the biophysical properties and behavior of the devices as measured against the specified ASTM standards. These are objective measurements rather than subjective assessments like expert consensus or pathology. No clinical outcomes data are presented for MR compatibility.
8. The sample size for the training set
This is not applicable as the document describes spinal implants (hardware) and non-clinical testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the document describes spinal implants (hardware) and non-clinical testing, not a machine learning model requiring a training set.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.