(76 days)
several commercially available devices.
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No
The device description focuses on mechanical components (rods, screws, staples) and their materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is designed to aid in surgical correction and stabilization of the spine until a solid spinal fusion develops, addressing various conditions like degenerative disc disease, pseudoarthrosis, stenosis, and spinal deformities. These functions are therapeutic as they treat or alleviate medical conditions.
No
The CD HORIZON™ Anterior Spinal System is a surgical implant designed to aid in the correction and stabilization of the spine, not to diagnose medical conditions.
No
The device description explicitly lists physical components such as rods, screws, a set screw, and staples, all fabricated from stainless steel. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The CD HORIZON™ Anterior Spinal System is a surgical implant designed to correct and stabilize the spine. It consists of physical components (rods, screws, staples) that are surgically implanted into the body.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples. The device's function is mechanical stabilization, not diagnostic testing of bodily fluids or tissues.
Therefore, the CD HORIZON™ Anterior Spinal System falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The CD HORIZON™ Anterior Spinal System is designed to aid in the surgical correction and stabilization of the system is intended to assist stabilization until a solid spinal fusion develops. The specific indications for the CD HORIZON™ Anterior Spinal System are the following: Degenerative disc disease (as defined by back pain of discogenic origin with degeneration ﮩ of the disc confirmed by patient history and radiographic studies). 2. Pseudoarthrosis 3. Stenosis 4. Spondylolisthesis 5. Spinal deformities: scoliosis, kyphosis, lordosis 6. Fracture 7. Unsuccessful previous attempts at spinal fusion 8. Tumor resection
All components of the CD HORIZON" Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only.
Product codes
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Device Description
The CD HORIZON™ Anterior Spinal System consists of rods, screws, a set screw, and staples. In general, the system features implant components which can be used with either 5.5mm and 6.35mm Sofamor Danek rods. The 5.5mm GDLH", 6.35mm TSRH®, and 6.35mm LIBERTY" rods can be used with the CD HORIZON™ Anterior Spinal System. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CD HORIZON" Anterior Spinal System is to provide stabilization during the development of a solid spinal fusion. The CD HORIZON" Anterior Spinal System implant components are fabricated from ASTM F138 (or its ISO equivalent) stainless steel 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
anterolateral spine in the thoracic and/or lumbar areas only
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)
Mechanical test data were supplied in support of the CD HORIZON™ Anterior Spinal System
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.
several commercially available devices.
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
§ 888.3060 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.
0
CD HORIZON™ Anterior Spinal System 510(k) Summary K963655 NOV 27 1996
November, 1996
NOV 27 1996
- l. Company: Sofamor Danek USA 1800 Pyramid Place Memohis. TN 38132 901-396-3133
- Proprietary Trade Name: CD HORIZON® Anterior Spinal System 11.
Spinal intervertebral body fixation orthosis. Classification Name:
- III. The CD HORIZON™ Anterior Spinal System consists of rods, screws, a set screw, and staples. In general, the system features implant components which can be used with either 5.5mm and 6.35mm Sofamor Danek rods. The 5.5mm GDLH", 6.35mm TSRH®, and 6.35mm LIBERTY" rods can be used with the CD HORIZON™ Anterior Spinal System. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CD HORIZON" Anterior Spinal System is to provide stabilization during the development of a solid spinal fusion. The CD HORIZON" Anterior Spinal System implant components are fabricated from ASTM F138 (or its ISO equivalent) stainless steel 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 CD HORIZON™ Anterior Spinal System is designed to aid in the surgical correction and stabilization of the system is intended to assist stabilization until a solid spinal fusion develops. The specific indications for the CD HORIZON™ Anterior Spinal System are the following:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration ﮩ of the disc confirmed by patient history and radiographic studies).
-
- Pseudoarthrosis
-
- Stenosis
-
- Spondylolisthesis
-
- Spinal deformities: scoliosis, kyphosis, lordosis
-
- Fracture
-
- Unsuccessful previous attempts at spinal fusion
- Tumor resection യ്
All components of the CD HORIZON" Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only.
- Mechanical test data were supplied in support of the CD HORIZON™ Anterior Spinal System V. The CD HORIZON™ Anterior Spinal System was declared to be 510(k) notification. substantially equivalent to several commercially available devices.