(81 days)
Not Found
No
The summary describes a physical medical device (spinal spacer system) and its materials, intended use, and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for spinal fusion procedures to treat degenerative disc disease, which involves a therapeutic intervention to address a medical condition.
No
The device is an implantable intervertebral body fusion system, not a diagnostic tool. Its purpose is to facilitate spinal fusion in patients with degenerative disc disease, not to diagnose the condition.
No
The device description explicitly details physical implants made from various materials (PEEK, tantalum, titanium alloy, commercially pure titanium) with specific physical features (teeth, porous geometry, graft aperture). This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The ATEC Cervical Spacer System is an implantable medical device designed to be surgically placed in the spine to facilitate fusion. It is made of materials like PEEK, tantalum, and titanium.
- Intended Use: The intended use is for spinal fusion procedures in patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The provided information clearly describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ATEC Cervical Spacer System is intended for spinal fusion procedures at one or two levels from C2 – T1 in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC Cervical Spacer System is intended for use with supplemental fixation systems and or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.
Product codes
ODP
Device Description
ATEC Cervical Spacer System includes Battalion Universal Spacer System and ATEC Porous Ti Spacer System that are implanted from an anterior cervical approach.
The ATEC Cervical Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and commercially pure titanium (CPTi Grade 2) per ASTM F67. The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally, the commercially pure titanium implants are offered with a microstructure due to the layering of material that forms the porous geometry. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation. All interbodies feature an internal graft aperture for placement of graft material to promote fusion through the cage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, one or two levels from C2 – T1
Indicated Patient Age Range
skeletally mature patients
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
Nonclinical testing was performed:
- Static and dynamic axial compression testing per ASTM F2077
- Static and dynamic torsion testing per ASTM F2077
- Subsidence testing per ASTM F2267
- Expulsion testing
- Particulate and gravimetric analysis per ASTM F1877 and ASTM F1714
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
Results: The results demonstrate that the subject ATEC Cervical Spacer System is substantially equivalent to other predicate devices for nonclinical testing.
No clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
K171140, K081730, K180480, K150362, K141376, K120603, P980048
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
August 21, 2018
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Alphatec Spine, Inc. Cynthia Adams Project Manager, Regulatory Affairs 5818 El Camino Real Carlsbad, California 92008
Re: K181435
Trade/Device Name: ATEC Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: July 30, 2018 Received: August 1, 2018
Dear Ms. Adams:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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,
Brent Showalter -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181435
Device Name ATEC Cervical Spacer System
Indications for Use (Describe)
The ATEC Cervical Spacer System is intended for spinal fusion procedures at one or two levels from C2 – T1 in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC Cervical Spacer System is intended for use with supplemental fixation systems and or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.
| 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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| I. | SUBMITTER: | Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 |
|----|------------------------|-------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Cynthia Adams
Project Manager, Regulatory Affairs
Contact Phone: (760) 494-6740 |
| | Date Summary Prepared: | July 30, 2018 |
II. DEVICE
| Name of Device: | ATEC Cervical Spacer System |
|---|---|
| Common or Usual Name: | Intervertebral fusion device with bone graft, Cervical |
| Classification Name: | Intervertebral body fusion device |
| (21 CFR 888.3080) | |
| Regulatory Class: | Class II |
| Product Code: | ODP |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K171140 | ODP, MQP, | ||
| MAX | Matrixx™ System | Nexxt Spine | |
| Additional Predicate Devices | |||
| K081730 | ODP | Novel® Cervical Spinal Spacer | |
| System | Alphatec Spine | ||
| K180480 | MAX, PHM | ATEC Universal Spacer System | Alphatec Spine |
| K150362 | ODP | CoRoent® Small Interbody System | NuVasive |
| K141376 | ODP, MQP, | ||
| MAX | Honour™ System | Nexxt Spine | |
| K120603 | ODP | Wenzel Spine VariLift Cervical | |
| Interbody Fusion Device | Wenzel Spine | ||
| P980048 | ODP | BAK/Cervical (BAK/C) Interbody | |
| Fusion System | Centerpulse Spine- | ||
| Tech Division |
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IV. DEVICE DESCRIPTION
ATEC Cervical Spacer System includes Battalion Universal Spacer System and ATEC Porous Ti Spacer System that are implanted from an anterior cervical approach.
The ATEC Cervical Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and commercially pure titanium (CPTi Grade 2) per ASTM F67. The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally, the commercially pure titanium implants are offered with a microstructure due to the layering of material that forms the porous geometry. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation. All interbodies feature an internal graft aperture for placement of graft material to promote fusion through the cage.
V. INDICATIONS FOR USE
The ATEC Cervical Spacer System is intended for spinal fusion procedures at one or two levels from C2 – T1 in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC Cervical Spacer System is intended for use with supplemental fixation systems and with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.
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 ATEC Cervical Spacer System supports substantial equivalence to other predicate devices. The following testing was performed:
- . Static and dynamic axial compression testing per ASTM F2077
- · Static and dynamic torsion testing per ASTM F2077
- Subsidence testing per ASTM F2267 .
- · Expulsion testing
- · Particulate and gravimetric analysis per ASTM F1877 and ASTM F1714
- · Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
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The results demonstrate that the subject ATEC Cervical Spacer 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. No clinical studies were conducted.
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.