(220 days)
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Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to provide temporary stabilization and augment spinal fusion for various conditions such as degenerative disc disease, pseudoarthrosis, stenosis, spondylolisthesis, spinal deformities, fracture, unsuccessful previous attempts at spinal fusion, and tumor resection. These are all therapeutic indications.
No
This device is a spinal rod-based system intended for temporary stabilization and to augment spinal fusion, which are therapeutic functions. It does not perform diagnostic functions like analyzing patient data to identify diseases or conditions.
No
The device description explicitly states it is a "spinal rod based system" with "implant components," indicating it is a physical medical device, not software-only.
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 and Intended Use: The description clearly states the CD HORIZON™ Spinal System is a spinal rod based system intended for temporary stabilization and augmentation of spinal fusion. It is implanted directly into the patient's spine.
- Lack of IVD Characteristics: There is no mention of testing biological samples, analyzing bodily fluids, or providing diagnostic information based on laboratory analysis.
Therefore, the CD HORIZON™ Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CD HORIZON™ Spinal System is intended to provide temporary stabilization and to help augment of a solid spinal fusion. Except for situations using pedients, (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (15-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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass, the specific indications for the CD HORIZON™ Spinal System are the following: Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by 1. patient history and radiographic studies). 2. Pseudoarthrosis Stenosis 4. Spondylolisthesis 5. Spinal deformities: scollosis, kyphosis, and lordosis 6. Fracture 7. Unsuccessful provious attempts at spinal fusion 8. Tumor resection
The CD HORIZON" Spinal System is intended for use only in the thoracic, lumbar, and/or sacral levels of the posterior spine. The CD HORIZON" Spinal System is limited to non-cervicel use. The CD HORIZON" Screws, TSRH" Variable Angle Screws, LIBERTY" screws, and/or DYNA-LOK" bolts, when used as pedicle screws with the CD HORIZON" Spinal System, is intended only for patients: (a) having severe spondylojisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vartebral 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 13 and not lower than the sacrum. Otherwise the CD HORIZON" screws, TSRH Variable Angle Screws, LIBERTY" screws, and/or DYNA-LOK" bolts, when used with the CD HORIZON" Spinal System, are intended for sacraliliac attachment only. The CGD™ Screw for Sacral Block and CCD™ Conical Fixation Screws are intended for sacraliliac attachment only. All of the CD HORIZON® hooks are intended for thoracic and/or lumbar attachment only. GDLH" CROSSLINK" Bars, CD HORIZON" Low Profile CROSSLINK" plates, and TSRH" CROSSLINK" plates 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 CD HORIZON" Spinal System is a spinal rod based system. The CD HORIZON" implant components, as well as the stainless steel implant components from the systems, can be rigidly locked into a variety of configurations, with each construct being tallor-made for the individual case. Implant compising the CD HORIZON" and those components from other stainless steel Sofanor Danek spinal systems which the CD HORIZON" Spinal System are listed in the following table.
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, lumbar, and/or sacral levels of the posterior 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 CD HORIZON Spinal System 510(k) notification. The CD HORIZON Spinal System was declared to be substantially equivalent to several commercially available devices.
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).
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
Spinal System 510(k) Summary November, 1996
- Sofamor Danek USA l. Company: 1800 Pyramid Place Memphis, TN 38132 901-396-3133
DEC - 5 1996
Proprietary Trade Name: CD HORIZON™ Spinal System 11.
Pedicle Screw Fixation - Spondylolisthesis spinal fixation device system. Dtherwise, Classification Name: spinal interlaminal fixation orthosis.
- The CD HORIZON" Spinal System is a spinal rod based system. The CD HORIZON" implant components, as well as the III. stainless steel implant components from the systems, can be rigidly locked into a variety of configurations, with each construct being tallor-made for the individual case. Implant compising the CD HORIZON" and those components from other stainless steel Sofanor Danek spinal systems which the CD HORIZON" Spinal System are listed in the following table. Please note that while some implants are identified for use on both size rods, some of these are designed for specific rod diameter.
| Component | 5.5mm Diameter Rod | 6.35mm Diameter Rod |
|---|---|---|
| Rods: | ||
| TSAH® Rods | ✓ | |
| GDLH® Rods | ✓ | |
| LIBERTY® Rods | ✓ | |
| CD HORIZON® Rod | ✓ | |
| Hooks: | ||
| CD HORIZON® Hooks | ✓ | ✓ |
| Screws/Bolts: | ||
| CD HORIZON® Screws | ||
| 5.5mm, 6.5mm, 7.5mm diameter | ✓ | ✓ |
| TSRH® Variable Angle Screws | ||
| 5.5mm, 6.5mm, 7.5mm diameter | ✓ | ✓ |
| DYNA-LOK® Bolts | ||
| 6.5mm, 7.0mm, 7.5mm, 8.5mm diameter | ✓ | ✓ |
| LIBERTY™ Screws | ||
| Closed-5.5mm, 6.5mm, 7.5mm diameter | ✓ | |
| Closed w/10° Oblique Canal-6.5mm, | ||
| 7.5mm diameter | ✓ | |
| Closed w/15° Oblique Canal-6.5mm, | ||
| 7.5mm diameter | ✓ | |
| Open-5.5mm, 6.5mm, 7.5mm diameter | ✓ | |
| CCD® Screw for Sacral Block, 7.0mm diameter | ✓ | ✓ |
| CCD® Conical Fixation Screws, 7.0mm diameter | ✓ | ✓ |
1
| Component | 5.5mm Diameter Rod | 6.35mm Diameter Rod |
|---|---|---|
| Connectors and Cross Connectors: | ||
| CD HORIZON® DTT No. 4 Connectors | ✓ | ✓ |
| CD HORIZON® Dominos | ✓ | ✓ |
| CD HORIZON® Axial Connectors | ✓ | ✓ |
| CD HORIZON® Sacral Fixation Device | ✓ | ✓ |
| CD HORIZON® C-rings | ✓ | ✓ |
| CD HORIZON® Low Profile MULTI-SPAN™ CROSSLINK® Plates | ✓ | ✓ |
| TSRH® Low Profile CROSSLINK® Offset Plates | ✓ | ✓ |
| TSRH® Low Profile CROSSLINK® Plates | ✓ | ✓ |
| TSRH® CROSSLINK® Plates | ✓ | ✓ |
| TSRH® Top Tightening Variable Angle T-Bolts, Variable Angle, and | ||
| Eyebolt Connectors | ✓ | ✓ |
| TSRH® Lateral Offset Plates | ✓ | ✓ |
| TSRH® Rod/Bolt Connectors | ✓ | ✓ |
| TSRH® Variable Angle Lateral Offset Plates | ✓ | ✓ |
| TSRH® Variable Angle CROSSLINK® Plates | ✓ | ✓ |
| TSRH® Fixed CROSSLINK® Plates | ✓ | ✓ |
| GDLH® CROSSLINK® Bars | ✓ | ✓ |
| GDLH® Rod/Bolt Connectors | ✓ | ✓ |
| LIBERTY® Lateral Connectors | ✓ | ✓ |
| LIBERTY® Open Implant Closure Saddle and Set Screw | ✓ | ✓ |
| CD HORIZON™, GDLH™, and TSRH® Set Screws and Fasteners | ✓ | ✓ |
- The CD HORIZON™ Spinal System is intended to provide temporary stabilization and to help augment IV. of a solid spinal fusion. Except for situations using pedients, (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (15-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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass, the specific indications for the CD HORIZON™ Spinal System are the following:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by 1. patient history and radiographic studies).
-
- Pseudoarthrosis
- న. Stenosis
-
- Spondylolisthesis
-
- Spinal deformities: scollosis, kyphosis, and lordosis
-
- Fracture
-
- Unsuccessful provious attempts at spinal fusion
-
- Tumor resection
The CD HORIZON" Spinal System is intended for use only in the thoracic, lumbar, and/or sacral levels of the posterior spine. The CD HORIZON" Spinal System is limited to non-cervicel use. The CD HORIZON" Screws, TSRH" Variable Angle Screws, LIBERTY" screws, and/or DYNA-LOK" bolts, when used as pedicle screws with the CD HORIZON" Spinal System, is intended only for patients: (a) having severe spondylojisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vartebral 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
2
only for insertion no higher than 13 and not lower than the sacrum. Otherwise the CD HORIZON" screws, TSRH Variable Angle Screws, LIBERTY" screws, and/or DYNA-LOK" bolts, when used with the CD HORIZON" Spinal System, are intended for sacraliliac attachment only. The CGD™ Screw for Sacral Block and CCD™ Conical Fixation Screws are intended for sacraliliac attachment only. All of the CD HORIZON® hooks are intended for thoracic and/or lumbar attachment only. GDLH" CROSSLINK" Bars, CD HORIZON" Low Profile CROSSLINK" plates, and TSRH" CROSSLINK" plates are intended for posterior thoracic, lumbar, and/or sacral use only.
V. Mechanical test data were supplied in support of the CD HORIZON Spinal System 510(k) notification. The CD HORIZON Spinal System was declared to be substantially equivalent to several commercially available devices.
© 1996 Sofamor Danek