Search Results

The Iatrical Lumbar Interbody Fusion Systems are indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Iatrical Lumbar Interbody Fusion Systems are intended for use in interbody fusions at the thoracolumbar junction (T12-L1), and are intended for use in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Iatrical Lumbar Interbody Fusion Systems can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The IatricalLumbar Interbody Fusion Systems are intervertebral body fusion systems used in the spine. The Iatrical Lumbar Interbody Fusion Systems (LLIF, TLIF, and ALIF) are comprised of various sizes and configurations to accommodate individual patient anatomy. They may be implanted bilaterally using an anterior (ALIF) approach, a lateral (LLF) approach, or as a single device employing a transformational (TLIF) approach.

3D printing technology is used in the manufacture of Iatrical Lumbar Interbody Fusion Systems using titanium alloy. The devices have large central graft windows which can be used with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation

Iatrical Lumbar Interbody Fusion Systems are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions.

Iatrical Lumbar Interbody Fusion Systems are delivered in a sterile condition and can be used without any further preparations. The devices are packaged in accordance with ISO 11607.

The provided text describes a 510(k) premarket notification for the "Iatrical Interbody Lumbar Fusion Systems." This submission is for a physical medical device (intervertebral body fusion system) and not for an AI/ML powered software or diagnostic device. Therefore, the information requested regarding acceptance criteria, study details, human reader performance, ground truth, and training set is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and performance data from mechanical testing. The performance data listed (e.g., Static Compression per ASTM F2077) are engineering tests for the physical device, not clinical or algorithmic performance metrics.

Ask a specific question about this device

CALIBER® Spacers are interbody fusion devices intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis. deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 at least six (6) months of non-operative treatment. All CALIBER® TPS coated spacers are indicated for the same use as non-coated PEEK spacers.

CALIBER® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).

The RISE® Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 at least six (6) months of non-operative treatment.

The RISE® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. This device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

LATIS® Spacers are interbody fusion devices intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 at least six (6) months of non-operative treatment.

LATIS® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).

The ALTERA® Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 at least six (6) months of non-operative treatment.

The ALTERA® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The MAGNIFY® Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kvphosis), spinal stenosis, and failed previous fusion (pseudarthrosis), 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 at least six (6) months of non-operative treatment.

The MAGNIFY® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone, and is to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

SABLE® Expandable Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications; degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 at least six (6) months of non-operative treatment. The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The MONUMENT® Spacer is an interbody fusion device indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). In addition, these patients may have up to Grade 2 spondylolisthesis or retrolisthesis at the involved level(s). 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 at least six (6) months of nonoperative treatment. All MONUMENT® TPS coated spacers are indicated for the same use as noncoated spacers.

The MONUMENT® Spacer is to be used with four screws that accompany the implant. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The MONUMENT® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

CALIBER® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. CALIBER® Spacers provide different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral). The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

RISE® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. RISE® Spacers are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral) and can expand to the desired height. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

LATIS® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. LATIS® Spacers are provided in a shape that accommodates a posterior, transforaminal, or lateral approach to the lumbar spine; after insertion the implant can be transformed to the desired footprint. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The ALTERA® Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The ALTERA® Spacer accommodates various surgical approaches to the lumbar spine (posterior or transforaminal [posterolateral]) and allows articulation upon insertion. The devices are available in various height ranges, allowing continuous expansion within the range, to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adiacent vertebrae to resist expulsion.

MAGNIFY® Spacers are expandable anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The devices are available in various height expansion ranges and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance.

SABLE® Spacers are expandable lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide varietv of patients.

The MONUMENT® Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The MONUMENT® Spacer is intended to aid in reduction of a Grade 1 spondylolisthesis. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation.

The provided text describes different types of interbody fusion devices (CALIBER®, RISE®, LATIS®, ALTERA®, MAGNIFY®, SABLE®, and MONUMENT® Spacers) and their indications for use, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of AI/algorithm performance.

The document is a 510(k) premarket notification for expanded indications and additional sterile implants for these devices. The "Performance Data" section mentions "Confirmatory mechanical testing was conducted on CALIBER® and RISE® spacers in accordance with ASTM F2077" and "Cadaveric testing was conducted on MONUMENT® spacers to support Grade 2 spondylolisthesis or retrolisthesis indications." It also states that "The sterilization and biocompatibility testing are unchanged for the subject and predicate devices" and "A biocompatibility risk assessment was conducted to assess the new sterile devices. No further sterilization or biocompatibility testing was required for this submission."

This information pertains to the physical performance of the interbody fusion devices and their biological compatibility, which are mechanical and material science tests. It does not describe any AI or algorithm-driven components, nor does it provide details about any clinical studies (like MRMC or standalone studies) with human readers, ground truth establishment, or sample sizes related to AI performance.

Therefore, for the specific questions related to acceptance criteria and studies proving AI device performance, the provided text does not contain the requested information.

Ask a specific question about this device