(60 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a spinal implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a spinal fusion system, which is used to treat a medical condition (degenerative disc disease) and restore function, aligning with the definition of a therapeutic device.
No
Explanation: This device is an intervertebral body fusion system designed for spinal fusion procedures. It is a medical implant used in treatment, not for diagnosing conditions.
No
The device description clearly states that the device is an intervertebral body fusion system including implants made from various materials (PEEK, titanium, tantalum) and fixation components (plates, screws). This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion procedures. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The device description details a physical implant made of various materials (PEEK, titanium, tantalum) designed to be placed between vertebrae.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
Therefore, the ATEC ALIF and LLIF Spacer System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ATEC ALIF and LLIF Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC ALIF and LLIF Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
ATEC LLIF interbody implants with >20° lordosis must be used with the ATEC LLIF AMP integrated fixation in addition to supplemental fixation. ATEC ALIF interbody implants with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX, PHM, OVD
Device Description
The ATEC ALIF and LLIF Spacer System is an intervertebral body fusion system. The ATEC ALIF and LLIF Spacer System includes interbody implants marketed as Battalion Universal Spacer System and IdentiTi Porous Ti Spacer System, implanted from an anterior, anterolateral and lateral approach. 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, titanium coating per ASTM F1580, 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 interbody implants feature an internal graft aperture for placement of graft material to promote fusion through the cage.
The ATEC ALIF and LLIF Spacer System also includes LLIF AMP integrated fixation to be used with the LLIF interbody offerings. The LLIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1); Lumbar: L1-L2 to L5-S1)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing performed on the ATEC ALIF and LLIF Spacer System supports substantial equivalence to other predicate devices. The following testing was performed:
- Dynamic axial compression testing per ASTM F2077
- Dynamic compression-shear testing per ASTM F2077 .
- Subsidence analysis .
- Push-out testing per ASTM F04-25-02-02 draft ●
- Particulate and gravimetric analysis per ASTM F1877 and ASTM F1714 ●
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016 ●
The results demonstrate that the subject ATEC ALIF and LLIF 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.
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.
K180480, K181453, K160958, K090782, K143740, K101255, K163543, K173892, K121791, K102402
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
§ 888.3080 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2018
Alphatec Spine, Inc. Ms. Cynthia Adams Project Manager, Regulatory Affairs 5818 El Camino Real Carlsbad, California 92008
Re: K182746
Trade/Device Name: ATEC ALIF and LLIF Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, PHM, OVD Dated: September 27, 2018 Received: September 28, 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 mav, 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 avare 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 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.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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.
Katherine D. Kavlock -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) K182746
Device Name ATEC ALIF and LLIF Spacer System
Indications for Use (Describe)
The ATEC ALIF and LLIF Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC ALIF and LLIF Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
ATEC LLIF interbody implants with >20° lordosis must be used with the ATEC LLIF AMP integrated fixation in addition to supplemental fixation. ATEC ALIF interbody implants with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.
| 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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3
510k Summary ATEC ALIF and LLIF Spacer System K182747
| 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: September 27, 2018
II. DEVICE
| Name of Device: | ATEC ALIF and LLIF Spacer System |
|---|---|
| Common or Usual Name: | Intervertebral fusion device with bone graft, lumbar |
| Classification Name: | Intervertebral body fusion device |
| (21 CFR 888.3080) | |
| Regulatory Class: | Class II |
| Product Code: | MAX, PHM, OVD |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K180480 | PHM, MAX | ATEC Universal Spacer System | Alphatec Spine |
| Additional Predicate Devices | |||
| K181453 | PHM, MAX | ATEC ALIF Spacer System | Alphatec Spine |
| K160958 | PHM, MAX | Battalion Universal Spacer System | Alphatec Spine |
| K090782 | MAX | Novel ALIF Spinal Spacer System | Alphatec Spine |
| K143740 | MAX | Battalion Universal Spacer System | Alphatec Spine |
| K101255 | KWQ | Anterior Lumbar Plating System | Alphatec Spine |
| K163543 | MAX, OVD | Zimmer Biomet Fusion System | Zimmer Biomet |
| K173892 | MAX, PHM, OVD | XLX Interbody System | NuVasive Inc. |
| K121791 | KWQ | Zou® Anterior Lumber Plate | |
| System | CoreLink LLC | ||
| K102402 | OVD | Solus Anterior Lumbar Interbody | |
| Fusion System | Alphatec Spine |
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IV. DEVICE DESCRIPTION
The ATEC ALIF and LLIF Spacer System is an intervertebral body fusion system. The ATEC ALIF and LLIF Spacer System includes interbody implants marketed as Battalion Universal Spacer System and IdentiTi Porous Ti Spacer System, implanted from an anterior, anterolateral and lateral approach. 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, titanium coating per ASTM F1580, 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 interbody implants feature an internal graft aperture for placement of graft material to promote fusion through the cage.
The ATEC ALIF and LLIF Spacer System also includes LLIF AMP integrated fixation to be used with the LLIF interbody offerings. The LLIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136.
V. INDICATIONS FOR USE
The ATEC ALIF and LLIF Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC ALIF and LLIF Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
ATEC LLIF interbody implants with >20° lordosis must be used with the ATEC LLIF AMP integrated fixation in addition to supplemental fixation. ATEC ALIF interbody implants with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.
5
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 ALIF and LLIF Spacer System supports substantial equivalence to other predicate devices. The following testing was performed:
- Dynamic axial compression testing per ASTM F2077
- Dynamic compression-shear testing per ASTM F2077 .
- Subsidence analysis .
- Push-out testing per ASTM F04-25-02-02 draft ●
- Particulate and gravimetric analysis per ASTM F1877 and ASTM F1714 ●
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016 ●
The results demonstrate that the subject ATEC ALIF and LLIF 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.
CONCLUSION VIII.
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.