(284 days)
Not Found
No
The description focuses on the mechanical components and intended use of a spinal fixation system, with no mention of AI or ML capabilities.
Yes
The device is a spinal implant system intended to provide stabilization during spinal fusion for various spinal conditions, indicating a direct therapeutic purpose.
No
Explanation: The device, the CD™ Spinal System, is described as consisting of rods, hooks, screws, and other components used to build a spinal construct for stabilization during spinal fusion, not for diagnosing conditions.
No
The device description explicitly states that the CD™ Spinal System consists of physical components such as rods, hooks, screws, connectors, and cross connectors, which are fabricated from stainless steel. This indicates it is a hardware-based medical device.
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, or tissue) to provide information about a person's health.
- Device Description: The description clearly states the CD Spinal System consists of physical components like rods, hooks, screws, and connectors used to build a spinal construct for stabilization during fusion. These are implanted devices, not devices used for testing samples outside the body.
- Intended Use: The intended use describes the conditions the device is used to treat (spondylolisthesis, degenerative disc disease, etc.) and how it is used (as pedicle screws, for posterior fixation, etc.). This is a description of a surgical implant and its application, not a diagnostic test.
Therefore, the CD Spinal System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CD spinal screws, when used as pedicle screws with the CD™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) 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. Otherwise, the CD 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 CD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the CD Spinal System (either stainless steel or titanium alloy versions) are the following:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by radiographic studies).
- Pseudoarthrosis
- Stenosis
- Spondylolisthesis
- Spinal deformities: scoliosis, kyphosis, and lordosis
- Fracture
- Unsuccessful previous attempts at spinal fusion
- Tumor resection
All of the CD hooks are intended for posterior thoracic and/or lumbar use only. CD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.
Product codes
Not Found
Device Description
The CDTM 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 CD™ Spinal System is to provide stabilization during the development of a solid spinal fusion. The CD™ Spinal System implant components are fabricated from ASTM F138 or its ISO equivalent stainless steel and may be sold sterile or non-sterile. Implant components made from different metal alloys must not be used together in a construct. The CD™ Spinal System is limited to non-cervical use in the posterior spine.
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, posterior spine, L5-S1 vertebral joint, sacral/iliac attachment, posterior thoracic, lumbar, 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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
Not Found
§ 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
OCT ।
Cotrel-Dubousset (CD™) Spinal System 510(k) Summary
Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, TN 38132 901-396-3133
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Proprietary Trade Name: Cotrel-Dubousset (CD™) Spinal System II.
Pedicle Screw Fixation - Spondylolisthesis spinal Classification Name: fixation device system. Otherwise, spinal interlaminal fixation orthosis. -
The CDTM Spinal System consists of rods, hooks, screws, connectors, cross III. 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 CD™ Spinal System is to provide stabilization during the development of a solid spinal fusion. The CD™ Spinal System implant components are fabricated from ASTM F138 or its ISO equivalent stainless steel and may be sold sterile or non-sterile. Implant components made from different metal alloys must not be used together in a construct.
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The CD™ Spinal System is limited to non-cervical use in the posterior spine. IV. The CD spinal screws, when used as pedicle screws with the CD™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) 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. Otherwise, the CD 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 CD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the CD Spinal System (either stainless steel or titanium alloy versions) are the following:
- Degenerative disc disease (as defined by back pain of discogenic origin with 1. degeneration of the disc confirmed by radiographic studies).
-
- Pseudoarthrosis
1
-
- Stenosis
- Spondylolisthesis 4.
- Spinal deformities: scoliosis, kyphosis, and lordosis 5.
-
- Fracture
- Unsuccessful previous attempts at spinal fusion 7.
- Tumor resection 8.
All of the CD hooks are intended for posterior thoracic and/or lumbar use only. CD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.
© 1996 Sofamor Danek