(80 days)
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No
The description focuses on the mechanical components and materials of a spinal implant system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to assist in temporarily stabilizing the thoracic and/or lumbar spine until fracture repair or a solid spinal fusion develops, which directly treats a medical condition.
No
The device is described as an anterior spinal system intended to stabilize the spine and contains various implant components, such as rods, screws, and staples, which are used in treatment rather than diagnosis.
No
The device description explicitly lists physical implant components made of titanium and titanium alloy, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a spinal system designed to stabilize the spine during fracture repair or fusion. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as consisting of rods, screws, set screws, and staples made of titanium. These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information about a patient's health status.
Therefore, the Titanium CD HORIZON™ Anterior Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Titanium CD HORIZON™ Anterior Spinal System is intended to assist in temporarily stabilizing the thoracic and/or lumbar spine until fracture repair or 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 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
All components of the Titanium 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 Titanium CD HORIZON™ Anterior Spinal System consists of the following implants components:
- CD HORIZON™ rod (commercially pure titanium), 6.35mm diameter
- CD HORIZON™ knurled rod (titanium alloy), 6.35mm diameter.
- TSRH® rod (titanium alloy), 6.35mm diameter.
- CD HORIZON™ screws (titanium alloy), 5.5mm, 6.5mm, and 7.5mm. diameters
- CD HORIZON™ Break-Off Set Screw (titanium alloy)
- CD HORIZON™ Staples (titanium alloy).
The Titanium TSRH® rod can be used with the Titanium CD HORIZON™ Anterior Spinal System. Instrumentation is also available to facilitate implantation of the device components. The Titanium CD HORIZON™ Anterior Spinal System implant components are fabricated from ASTM F136 (or its ISO equivalent) titanium alloy. In addition, the Titanium CD HORIZON™ Anterior Spinal System has a rod fabricated from commercially pure titanium conforming to ASTM F67 or its ISO equivalent. The implant components may be sold sterile or non-sterile. Titanium implants are not to be used with stainless steel 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
thoracic and/or lumbar 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical test data were supplied in support of the Titanium CD HORIZON™ Anterior Spinal System 510(k) notification.
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
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§ 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
FEB - 6 1997
Titanium CD HORIZON" Anterior Spinal System 510(k) Summary K964623 February, 1997
- Sofamor Danek USA Company: 1800 Pyramid Place Memphis, TN 38132 901-396-3133
-
Proprietary Trade Name: Titanium CD HORIZON™ Anterior Spinal System ll.
Classification Name: Spinal intervertebral body fixation orthosis. -
III. The Titanium CD HORIZON" Anterior Spinal System consists of the following implants components:
- CD HORIZON™ rod (commercially pure titanium), 6.35mm diameter
- CD HORIZON™ knurled rod (titanium alloy), 6.35mm diameter .
- TSRH® rod (titanjum alloy), 6.35mm diameter .
- CD HORIZON™ screws (titanium alloy), 5.5mm, 6.5mm, and 7.5mm . diameters
- CD HORIZON™ Break-Off Set Screw (titanium alloy) t
- CD HORIZON™ Staples (titanium allov) .
The Titanium TSRH® rod can be used with the Titanium CD HORIZON™ Anterior Spinal System. Instrumentation is also available to facilitate implantation of the device components. The Titanium CD HORIZON™ Anterior Spinal System implant components are fabricated from ASTM F136 (or its ISO equivalent) titanium alloy. In addition, the Titanium CD HORIZON" Anterior Spinal System has a rod fabricated from commercially pure titanium conforming to ASTM F67 or its ISO equivalent. The implant components may be sold sterile or non-sterile. Titanium implants are not to be used with stainless steel implant components in a spinal construct
- IV. The Titanium CD HORIZON™ Anterior Spinal System is intended to assist in temporarily stabilizing the thoracic and/or lumbar spine until fracture repair or a solid spinal fusion develops. The specific indications for the CD HORIZON" Anterior Spinal System are the following:
1
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
-
- Pseudoarthrosis
-
- Stenosis
-
- Spondvlolisthesis
-
- Spinal deformities: scoljosis, kyphosis, lordosis
-
- Fracture
-
- Unsuccessful previous attempts at spinal fusion
-
- Tumor resection
All components of the Titanium 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 Titanium CD HORIZON™ V. The Titanium CD HORIZON™ Anterior Spinal System 510(k) notification. Anterior Spinal System was declared to be substantially equivalent to other commercially available devices.
- C 1997 Sofamor Danek