(81 days)
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Not Found
No
The description focuses on the mechanical components and intended use of a spinal implant system, with no mention of AI or ML capabilities.
Yes
The device is described as "temporary stabilization" and aids in "development of a solid spinal fusion," indicating a direct effect on the spine to improve a medical condition.
No
The device, the ALPHA™ Posterior Spinal System, is described as a spinal rod-based system intended for temporary stabilization and to augment spinal fusion. It is an implant used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a "spinal rod based system" and lists "implant components," indicating it is a physical medical device, not software.
Based on the provided text, 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: The ALPHA™ Posterior Spinal System is described as a "spinal rod based system" with "implant components" intended for "posterior spinal fixation." This clearly indicates a surgical implant used within the body, not a test performed on samples taken from the body.
- Intended Use: The intended use is to "provide temporary stabilization and to help augment the development of a solid spinal fusion" in patients with severe spondylolisthesis. This is a therapeutic intervention, not a diagnostic test.
The text describes a medical device used in surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ALPHA™ Posterior Spinal System is intended to provide temporary stabilization and to help augment the development of a solid spinal fusion. The system is intended only patients (a) having severe spondylolisthesis (Grades 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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
NOTA BENE: The ALPHA" Posterior Spinal System is limited to non-cervical use. All implant components of the ALPHA" Posterior Spinal System are intended for posterior spinal fixation. The ALPHA" Posterior Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 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. The ALPHA" screws are indicated only for insertion no higher than L3 and not lower than the sacrum. CD HORIZON" Low Profile MULTI-SPAN" CROSSLINK® plates, ALPHA" Low Profile MULTI-SPAN" CROSSLINK® plates, TSRH® Low Profile CROSSLINK® plates, and TSRH® Low Profile CROSSLINK® Offset plates are intended for posterior thoracic, lumbar, and/or sacral use only.
Product codes
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Device Description
The ALPHA" Posterior Spinal System is a spinal rod based system. The ALPHA" implant components, as well as implant components from the other systems, can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Implant components comprising the ALPHA system and those components from other Sofamor Danek spinal systems which can be used with the ALPHA~ Posterior Spinal System are listed in the following table. Please note that while the set screws can be used on both size rods, all of the other components are rod-size specific.
| Component | 5.5mm Diameter Rod | 6.35mm Diameter Rod |
|---|---|---|
| Rods: | ||
| TSRH® Rods | ✓ | |
| GDLH™ Rods | ✓ | |
| ALPHA™ Rod | ✓ | |
| Screws: | ||
| ALPHA™ Screws | ||
| 5.5mm, 6.5mm, 7.5mm diameter | ✓ | ✓ |
| Connectors and Cross Connectors: | ||
| CD HORIZON™ M-10 Break-Off Set Screw | ✓ | ✓ |
| ALPHA™ M-10 Break-Off Set Screw | ✓ | ✓ |
| CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates | ✓ | ✓ |
| ALPHA™ Low Profile MULTI-SPAN™ CROSSLINK® Plates | ✓ | ✓ |
| TSRH® Low Profile CROSSLINK® Offset Plates | ✓ | ✓ |
| TSRH® Low Profile CROSSLINK® Plates | ✓ | ✓ |
| TSRH® CROSSLINK® Plate Set Screws | ✓ | ✓ |
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Fifth lumbar - first sacral (L5-S1) vertebral joint, lumbar and sacral spine (L3 and below), 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)
Mechanical test data were supplied in support of the ALPHA™ Posterior 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.
Not Found
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
ALPHA™ Posterior Spinal System K964275 510(k) Summary K964275 January, 1997
JAN. 14, 1997
- l, Company: Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 901-396-3133
- ll. Proprietary Trade Name: ALPHA™ Posterior Spinal System
Pedicle Screw Fixation - Spondylolisthesis spinal fixation device Classification Name: system.
- The ALPHA" Posterior Spinal System is a spinal rod based system. The ALPHA" implant III. components, as well as implant components from the other systems, can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Implant components comprising the ALPHA system and those components from other Sofamor Danek spinal systems which can be used with the ALPHA~ Posterior Spinal System are listed in the following table. Please note that while the set screws can be used on both size rods, all of the other components are rod-size specific.
| Component | 5.5mm Diameter Rod | 6.35mm Diameter Rod |
|---|---|---|
| Rods: | ||
| TSRH® Rods | ✓ | |
| GDLH™ Rods | ✓ | |
| ALPHA™ Rod | ✓ | |
| Screws: | ||
| ALPHA™ Screws | ||
| 5.5mm, 6.5mm, 7.5mm diameter | ✓ | ✓ |
| Connectors and Cross Connectors: | ||
| CD HORIZON™ M-10 Break-Off Set Screw | ✓ | ✓ |
| ALPHA™ M-10 Break-Off Set Screw | ✓ | ✓ |
| CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates | ✓ | ✓ |
| ALPHA™ Low Profile MULTI-SPAN™ CROSSLINK® Plates | ✓ | ✓ |
| TSRH® Low Profile CROSSLINK® Offset Plates | ✓ | ✓ |
| TSRH® Low Profile CROSSLINK® Plates | ✓ | ✓ |
| TSRH® CROSSLINK® Plate Set Screws | ✓ | ✓ |
- IV. The ALPHA™ Posterior Spinal System is intended to provide temporary stabilization and to help augment the development of a solid spinal fusion. The system is intended only patients (a) having severe spondylolisthesis (Grades 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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
1
NOTA BENE: The ALPHA" Posterior Spinal System is limited to non-cervical use. All implant components of the ALPHA" Posterior Spinal System are intended for posterior spinal fixation. The ALPHA" Posterior Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 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. The ALPHA" screws are indicated only for insertion no higher than L3 and not lower than the sacrum. CD HORIZON" Low Profile MULTI-SPAN" CROSSLINK® plates, ALPHA" Low Profile MULTI-SPAN" CROSSLINK® plates, TSRH® Low Profile CROSSLINK® plates, and TSRH® Low Profile CROSSLINK® Offset plates are intended for posterior thoracic, lumbar, and/or sacral use only.
- Mechanical test data were supplied in support of the ALPHA™ Posterior Spinal System 510(k) V. notification. The ALPHA" Posterior Spinal System was declared to be substantially equivalent to several commercially available devices.
©1997 Sofamor Danek