(126 days)
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No
The document describes a mechanical spinal implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as a "Spinal System" with components like rods, hooks, and screws, intended to provide "stabilization during the development of a solid spinal fusion" for various spinal conditions such as spondylolisthesis, degenerative disc disease, and fractures. This directly indicates its use in treating medical conditions, which aligns with the definition of a therapeutic device.
No
The CCD Spinal System is described as a surgical implant designed to provide stabilization during spinal fusion, not to diagnose a medical condition. Its components include rods, hooks, screws, and connectors used to build a spinal construct.
No
The device description explicitly states that the CCD™ Spinal System consists of physical components such as rods, hooks, screws, connectors, and cross connectors, which are hardware implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The CCD™ Spinal System is described as consisting of rods, hooks, screws, connectors, and other components used to build a spinal construct. Its purpose is to provide stabilization during spinal fusion.
- Intended Use: The intended use is for surgical implantation in the spine to treat various spinal conditions.
The device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The CCD™ Spinal System is limited to non-cervical use in the posterior spine. The CCD spinal screws, when used as pedicle screws with the CCD™ Spinal' System, are intended only for patients: (a) having severe spondylolisthesis (grade 3 and 4) of the fifth lumbar-first sacral (L5-Sl) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and(d) who are having the device removed after the development of a solid fusion mass. When used for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than L3 and no lower than the sacrum. Otherwise, the CCD screws, when used in posterior fixation, are intended for sacral/iliac attachment only. Except for situations where stainless steel screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a CCD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-Sl vertebral joint, the specific indications for the CCD Spinal System (either stainless steel or titanium alloy versions) are the following:
- Degenerative disc disease (as defined by instability in the presence of one or more of the following: osteophyte formation, decrease in disc space height, endplate sclerosis, disc herniations, facet joint changes, and scarring and / or thickening of the annulus fibrosis, ligamentum flavum, or facet joint capsule).
- Pseudoarthrosis
- Stenosis
- Spondylolisthesis
- Spinal deformities: scoliosis, kyphosis, and lordosis
- Fracture
- Unsuccessful previous attempts at spinal fusion
- Tumor resection
All of the CCD hooks are intended for posterior thoracic and/or lumbar use only. CCD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The CCD™ Spinal System consists of rods, hooks, screws, connectors, cross connectors, and other components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CCD™ Spinal System is to provide stabilization during the development of a solid spinal fusion. The CCDTM Spinal System implant components are fabricated either from ASTM F138 or its ISO equivalent stainless steel or titanium alloy conforming to ASTM F136 or its ISO equivalent (non-pedicle screw indications only) and may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implant components in a spinal construct.
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
non-cervical use in the posterior spine, fifth lumbar-first sacral (L5-Sl) vertebral joint, lumbar and sacral spine, L3, sacrum, sacral/iliac, posterior thoracic and/or lumbar, posterior thoracic, lumbar, and/or sacral
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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
Kgss365
Compact Cotrel-Dubousset (CCD™) Spinal System 510(k) Summary
Kasssos
I. Sofamor Danek USA Company: 1800 Pyramid Place Memphis, TN 38132 901-396-3133
27
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II. Proprietary Trade Name: Cotrel-Dubousset (CCD™) Spinal System
Pedicle Screw Fixation - Spondylolisthesis spinal Classification Name: fixation device system. Otherwise, spinal interlaminal fixation orthosis. -
III. The CCD™ Spinal System consists of rods, hooks, screws, connectors, cross connectors, and other components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CCD™ Spinal System is to provide stabilization during the development of a solid spinal fusion. The CCDTM Spinal System implant components are fabricated either from ASTM F138 or its ISO equivalent stainless steel or titanium alloy conforming to ASTM F136 or its ISO equivalent (non-pedicle screw indications only) and may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implant components in a spinal construct.
- IV. The CCD™ Spinal System is limited to non-cervical use in the posterior spine. The CCD spinal screws, when used as pedicle screws with the CCD™ Spinal' System, are intended only for patients: (a) having severe spondylolisthesis (grade 3 and 4) of the fifth lumbar-first sacral (L5-Sl) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and(d) who are having the device removed after the development of a solid fusion mass. When used for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than L3 and no lower than the sacrum. Otherwise, the CCD screws, when used in posterior fixation, are intended for sacral/iliac attachment only. Except for situations where stainless steel screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a CCD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-Sl vertebral joint, the specific indications for the CCD Spinal System (either stainless steel or titanium alloy versions) are the following:
1
- Degenerative disc disease (as defined by instability in the presence of one or 1. more of the following: osteophyte formation, decrease in disc space height, endplate sclerosis, disc herniations, facet joint changes, and scarring and / or thickening of the annulus fibrosis, ligamentum flavum, or facet joint capsule).
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- Pseudoarthrosis
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- Stenosis
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- Spondylolisthesis
- Spinal deformities: scoliosis, kyphosis, and lordosis 5.
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- Fracture
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- Unsuccessful previous attempts at spinal fusion
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- Tumor resection
All of the CCD hooks are intended for posterior thoracic and/or lumbar use only. CCD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.