(62 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes
The intended use of the OsseoScrew™ System describes its purpose as "to restore the integrity of the spinal column... in patients with advanced stage tumors involving the thoracic and lumbar spine," which directly addresses the treatment of a medical condition.
No
The device description indicates it is a pedicle screw system, which is an implantable surgical device used to restore the integrity of the spinal column, not to diagnose a condition.
No
The device description clearly states that the OsseoScrew System consists of physical components (pedicle screws, instruments, rods) made of titanium alloy, indicating it is a hardware-based medical device.
No, 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 fixation system used to restore the integrity of the spinal column in patients with advanced stage tumors. This is a surgical implant used directly on the patient's body.
- Device Description: The description details a pedicle screw system made of titanium alloy, designed to be implanted into the spine. This is a physical medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
The OsseoScrew™ System (for use with the Zodiac™ Spinal Fixation System and Illico™ MIS Posterior Fixation System) is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Product codes
NKB
Device Description
The OsseoScrew is a pedicle screw system that consists of pedicle screws and associated general instruments. Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions of the patient. The subject cannulated polyaxial pedicle screws are in diameters of 6.5mm and 7.5mm with lengths ranging from 40 to 55mm. The OsseoScrew is designed to connect to 5.5mm diameter rods and the associated components contained within the Zodiac Spinal Fixation System and the Illico MIS Posterior Spinal Fixation Systems. The Alphatec Spine OsseoScrew System is an implantable pedicle screw device whose core is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and the expandable screw shank is manufactured from CP2 Titanium conforming to ASTM F67 which are both industry recognized standards.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
thoracic and lumbar spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Performance data and engineering analysis demonstrate that the subject OsseoScrew System is substantially equivalent to the predicates. Testing and analysis include static shank torsion, static shank tensile, dynamic shank bending, dynamic construct compression and static construct compression. Clinical data on the subject device has been provided to support a substantial equivalence determination.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services-USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
September 25, 2018
Alphatec Spine, Inc. Mr. Jeremy Markovich Senior Manager, Regulatory and Clinical Affairs 5818 El Camino Real Carlsbad, California 92008
Re: K181980
Trade/Device Name: OsseoScrew System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: July 24, 2018 Received: July 25, 2018
Dear Mr. Markovich:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181980
Device Name OsseoScrew System
Indications for Use (Describe)
The OsseoScrew™ System (for use with the Zodiac™ Spinal Fixation System and Illico™ MIS Posterior Fixation System) is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Atec. The logo consists of a green square with a white curved line running through it, followed by the word "atec" in white sans-serif font. A trademark symbol is located to the upper right of the word "atec". The background of the logo is a dark blue color.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER: | Alphatec Spine, Inc. |
|---|---|---|
| 5818 El Camino Real | ||
| Carlsbad, CA 92008 | ||
| Phone: (760) 431-9286 | ||
| Fax: (760) 431-0289 | ||
| Contact Person: | Jeremy Markovich | |
| Senior Manager, Regulatory and Clinical Affairs | ||
| Contact Phone: (760) 494-6893 | ||
| Date Summary Prepared: | September 24, 2018 |
II. DEVICE
| Name of Device: | OsseoScrew System |
|---|---|
| Common or Usual Name: | Orthosis, Spinal Pedicle Fixation |
| Classification Name: | Thoracolumbosacral pedicle screw system |
| Regulation Number: | 21 CFR 888.3070 |
| Regulatory Class: | Class II |
| Product Code: | NKB |
III. LEGALLY MARKETED PREDICATE DEVICES
Primary Predicate:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K123623 | Illico™ MIS Posterior Fixation System | February 14, 2013 |
Additional Predicates:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K160879 | CONFIDENCE™ High Viscosity Spinal Cement, | |
| VIPER® And EXPEDIUM® Fenestrated Screw Systems | December 20, 2016 |
IV. DEVICE DESCRIPTION
The OsseoScrew is a pedicle screw system that consists of pedicle screws and associated general instruments. Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions of the patient.
The subject cannulated polyaxial pedicle screws are in diameters of 6.5mm and 7.5mm with lengths ranging from 40 to 55mm. The OsseoScrew is designed to connect to 5.5mm
4
Image /page/4/Picture/0 description: The image shows the logo for ATEC. The logo consists of a green square with a white curved line inside, followed by the word "atec" in white letters. The letters are lowercase and have a modern, sans-serif font. The background of the logo is a dark blue color.
diameter rods and the associated components contained within the Zodiac Spinal Fixation System and the Illico MIS Posterior Spinal Fixation Systems.
The Alphatec Spine OsseoScrew System is an implantable pedicle screw device whose core is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and the expandable screw shank is manufactured from CP2 Titanium conforming to ASTM F67 which are both industry recognized standards.
V. INDICATIONS FOR USE
The OsseoScrew™ System (for use with the Zodiac™ Spinal Fixation System and Illico™ MIS Posterior Fixation System) is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. The different technological characteristics do not raise different questions of safety and effectiveness.
VII. PERFORMANCE DATA
Performance data and engineering analysis demonstrate that the subject OsseoScrew System is substantially equivalent to the predicates. Testing and analysis include static shank torsion, static shank tensile, dynamic shank bending, dynamic construct compression and static construct compression.
Clinical data on the subject device has been provided to support a substantial equivalence determination.
VIII. CONCLUSION
Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance,