(129 days)
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No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
No
The device provides mechanical stabilization to aid in surgical correction and spinal fusion, rather than directly treating or curing a medical condition through therapeutic action.
No
The device is a surgical implant designed to stabilize the spine and promote fusion, not to diagnose a condition.
No
The device description explicitly states it "consists of single use devices designed to aid in the surgical correction of several types of spinal conditions," indicating it is a physical implantable system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to provide mechanical stabilization to the spine during fusion. It is used in vivo (within the body) during a surgical procedure.
- Device Description: The description reinforces that it's a system of single-use devices for surgical correction and stabilization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests outside of the body on biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The Thorocolumbar Spinal System consists of single use devices designed to aid in the surgical correction of several types of spinal conditions by providing stabilization until a solid spinal fusion develops.
When used as a pedicle screw system, the Thorocolumbar Spinal System when used in constructs with screws or spinal bolts placed in the pedicle are intended only for: grades 3 or 4 spondylolisthesis at the fifth lumbar-first sacral vertebral (LS-S1) joint: who are receiving fusion using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of solid fusion.
When used as a posterior hook and sacral/iliac screw fixation system only, the Thorocolumbar Spinal System is indicated for:
Scoliotic, lordotic, or kyphotic deformities
ddd ((defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- pseudarthrosis stenosis spondylolisthesis (grade 1 or 2) fracture tumor resection
As a posterior system, it is limited to non-cervical posterior use with the levels of posterior screw fixation from L3-S1.
As an anterolateral spinal system the indications are for anterior stabilization of levels T10 to L5 of the spine following: degenerative disc disease (defined above), tumor resection, spondylolisthesis, spondylolysis, fracture, pseudoarthrosis, and multi-operated back; and to correct lordotic and kyphotic spinal deformities.
The levels of anterolateral use are T10-L5.
Product codes
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Device Description
The Thorocolumbar Spinal System consists of single use devices designed to aid in the surgical correction of several types of spinal conditions by providing stabilization until a solid spinal fusion develops.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fifth lumbar-first sacral vertebral (LS-S1) joint, lumbar and sacral spine, non-cervical posterior use with the levels of posterior screw fixation from L3-S1, T10 to L5 of the spine
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Testing of the Thorocolumbar Spinal System included comparison to substantially equivalent devices. The testing results were acceptable and the components should perform as well as comparable systems in clinical usage.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
MAY - 8, 1997
Attachment 7 REVISED 510(K) SUMMARY
K96 5224
Summary of Safety and Effectiveness
Thorocolumbar Spinal System
The Thorocolumbar Spinal System consists of single use devices designed to aid in the surgical correction of several types of spinal conditions by providing stabilization until a solid spinal fusion develops.
When used as a pedicle screw system, the Thorocolumbar Spinal System when used in constructs with screws or spinal bolts placed in the pedicle are intended only for: grades 3 or 4 spondylolisthesis at the fifth lumbar-first sacral vertebral (LS-S1) joint: who are receiving fusion using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of solid fusion.
When used as a posterior hook and sacral/iliac screw fixation system only, the Thorocolumbar Spinal System is indicated for:
Scoliotic, lordotic, or kyphotic deformities
ddd ((defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- pseudarthrosis stenosis spondylolisthesis (grade 1 or 2) fracture tumor resection
As a posterior system, it is limited to non-cervical posterior use with the levels of posterior screw fixation from L3-S1.
As an anterolateral spinal system the indications are for anterior stabilization of levels T10 to L5 of the spine following: degenerative disc disease (defined above), tumor resection, spondylolisthesis, spondylolysis, fracture, pseudoarthrosis, and multi-operated back; and to correct lordotic and kyphotic spinal deformities.
The levels of anterolateral use are T10-L5.
Testing of the Thorocolumbar Spinal System included comparison to substantially equivalent devices. The testing results were acceptable and the components should perform as well as comparable systems in clinical usage.