(55 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is an implantable system for spinal stabilization, which is a treatment, but the primary function is structural support rather than directly applying a therapeutic agent or energy.
No
The device, ATEC Lateral Plate System, is described as an implant used for temporary stabilization of the spine until fusion occurs, indicating it is a therapeutic or surgical device, not one for diagnosis.
No
The device description explicitly states the system is comprised of "implants manufactured from titanium alloy" and "required instruments to place them," indicating it is a hardware-based medical device.
No, 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 ATEC Lateral Plate System is a surgical implant made of titanium alloy, intended for stabilizing the spine during fusion. It is a physical device implanted into the body.
- Intended Use: The intended use describes the surgical application of the device for treating spinal instability. It does not involve testing biological samples.
The provided information clearly describes a surgical implant used for structural support within the body, which falls under the category of medical devices, but not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ATEC Lateral Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1- S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery
Product codes
KWQ
Device Description
The ATEC Lateral Plate System is implanted through a lateral or anterolateral surgical approach to the thoracolumbar spine to provide temporary stabilization until fusion has occurred. The system will be comprised of both implants manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136 for fixation and the required instruments to place them.
ATEC Lateral Plate System implants will be provided in a range of sizes and lengths used to create a construct to immobilize the spinal segments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar (T1-L5) spine, lumbosacral (L1- S1) spine, thoracic and thoracolumbar (T1-L5) spine, lumbar and lumbosacral (L1- S1) 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing performed on the subject ATEC Lateral Plate System, supports substantial equivalence to the other predicate devices. The following testing was performed:
- Static Axial Compression Bending testing per ASTM F1717
- Dynamic Axial Compression Bending testing per ASTM F1717
- Static Torsion testing per ASTM F1717
- Static Screw Push-out testing
The results demonstrate that the subject ATEC Lateral Plate System is substantially equivalent to other predicate devices for nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K202624, K092108, K180166, K221926, K182808
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
May 9, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it.
Alphatec Spine, Inc. Aditya Aiyer Regulatory Affairs Specialist 1950 Camino Vida Roble Carlsbad, California 92008
Re: K230721
Trade/Device Name: ATEC Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 15, 2023 Received: March 15, 2023
Dear Aditya Aiyer:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230721
Device Name ATEC Lateral Plate System
Indications for Use (Describe)
The ATEC Lateral Plate System is intended for use via the lateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1- S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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/1 description: The image shows the logo for "atec". The "a" is green, and the rest of the letters are dark blue. There is a trademark symbol to the right of the "c". There is a black line underneath the logo.
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.
1950 Camino Vida Roble
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 |
|-----|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Aditya Aiyer
Regulatory Affairs Specialist
Contact Phone: (760) 494-6671 |
| | Date Summary Prepared: | March 15, 2023 |
| II. | DEVICE | |
| | Name of Device:
Common or Usual Name:
Classification Name: | ATEC Lateral Plate System
Spinal Intervertebral Body Fixation Org
Spinal Intervertebral Body Fixation Org |
Regulatory Class: Product Code:
hosis hosis (21 CFR 888.3060) Class II KWQ
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K202624 | KWQ | Z-Span Plate System | Zavation |
| Additional Predicate/Reference Devices | |||
| K092108 | KWQ | TRUSS™ Thoracolumbar Plate | |
| System | Globus | ||
| K180166 | KWQ | Life Spine Lumbar Fixation System | |
| (SENTRY®) | Life Spine | ||
| K221926 | PML, NKB, | ||
| KWP, KWQ | Invictus® Bone Cement, Invictus | ||
| Spinal Fixation System | Alphatec Spine | ||
| K182808 | KWQ | Aspida Anterior Lumbar Plating | |
| System | Alphatec Spine |
IV. DEVICE DESCRIPTION
The ATEC Lateral Plate System is implanted through a lateral or anterolateral surgical approach to the thoracolumbar spine to provide temporary stabilization until fusion has occurred. The system will be comprised of both implants manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136 for fixation and the required instruments to place them.
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Image /page/4/Picture/1 description: The image shows the logo for "atec". The "a" is green and the rest of the letters are dark blue. There is a green swoosh over the "a" and the "t". There is a trademark symbol next to the "c". There is a black line under the logo.
ATEC Lateral Plate System implants will be provided in a range of sizes and lengths used to create a construct to immobilize the spinal segments.
The purpose of this submission is to seek initial clearance for the ATEC Lateral Plate System.
V. INDICATIONS FOR USE
The ATEC Lateral Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1- S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery
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.
VII. PERFORMANCE DATA
Nonclinical testing performed on the subject ATEC Lateral Plate System, supports substantial equivalence to the other predicate devices. The following testing was performed:
- Static Axial Compression Bending testing per ASTM F1717 ●
- Dynamic Axial Compression Bending testing per ASTM F1717 ●
- Static Torsion testing per ASTM F1717 ●
- Static Screw Push-out testing ●
The results demonstrate that the subject ATEC Lateral Plate System is substantially equivalent to other predicate devices for nonclinical testing.
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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Image /page/5/Picture/1 description: The image shows the logo for "atec". The "a" is green, while the "tec" is dark blue. There is a horizontal line underneath the logo.
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 regard to indications for use, intended use, design, technology, and performance.