(60 days)
Not Found
No
The document describes a physical medical device (interbody fusion system) and its materials, dimensions, and intended use in spinal fusion. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is intended for spinal fusion procedures to treat degenerative disc disease and related conditions, which directly addresses a medical condition or disease.
No
Explanation: This device is an interbody fusion system (implant) used in spinal fusion procedures, not for diagnosing medical conditions.
No
The device description clearly states that the device is an intervertebral body fusion system made of commercially pure titanium and includes physical components like implants, fixation plates, screws, and graft apertures. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The IdentiTi Porous Ti Interbody System is a surgical implant intended for spinal fusion procedures. It is a physical device implanted into the body to provide structural support and promote bone growth.
- Lack of Diagnostic Function: The description and intended use do not mention any function related to analyzing biological specimens or providing diagnostic information.
Therefore, the IdentiTi Porous Ti Interbody System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IdentiTi™ Porous Ti Interbody System
IdentiTi Cervical Platform
The IdentiTi Porous Ti Interbody 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 IdentiTi Porous Ti Interbody 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.
IdentiTi Thoracolumbar Platform
The IdentiTi Porous Ti Interbody 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 degenerative 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 IdentiTi Porous Ti Interbody 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.
IdentiTi LLIF interbody spacers with >20° lordosis must be used with LLIF AMP integrated fixation in addition to supplemental fixation. IdentiTi ALIF interbody spacers 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, ODP
Device Description
The IdentiTi Porous Ti Interbody System is an intervertebral body fusion system implanted from an anterior, anterolateral, lateral or posterior approach. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured from 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 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 IdentiTi Porous Ti Interbody 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
Cervical spine (C2 – T1), Thoracolumbar spine (T1-T2 to T11-T12, T12-L1, 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 predicate devices supports the design of the subject IdentiTi Porous Ti Interbody System. Additionally, the following testing was performed on the subject interbody implants:
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
The results demonstrate that the subject IdentiTi Porous Ti Interbody 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.
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 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 blue.
March 1, 2019
Alphatec Spine, Inc. Cynthia Adams Project Manager, Regulatory Affairs 5818 El Camino Real Carlsbad, California 92008
Re: K183705
Trade/Device Name: IdentiTi™ Porous Ti Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM, OVD, ODP Dated: December 28, 2018 Received: December 31, 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
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 (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,
Melissa Hall -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)
Device Name IdentiTi™ Porous Ti Interbody System
Indications for Use (Describe)
IdentiTi Cervical Platform
The IdentiTi Porous Ti Interbody 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 IdentiTi Porous Ti Interbody 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.
IdentiTi Thoracolumbar Platform
The IdentiTi Porous Ti Interbody 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 degenerative disc disease (DD), 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 IdentiTi Porous Ti Interbody System is intended for use on patients who have had at least six months of nonoperative 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. IdentiTi LLIF interbody spacers with >20° lordosis must be used with LLIF AMP integrated fixation to supplemental fixation. IdentiTi ALIF interbody spacers 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the logo for Atec. The logo consists of a green square with rounded corners and a white stylized letter "a" inside. To the right of the square is the word "tec" in white, with a small trademark symbol in the upper right corner. The background of the image 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: | Cynthia Adams
Project Manager, Regulatory Affairs
Contact Phone: (760) 494-6740 |
| | Date Summary Prepared: | December 28, 2018 |
| II. | DEVICE | |
| | Name of Device:
Common or Usual Name: | IdentiTiTM Porous Ti Interbody System
Intervertebral fusion device with bone graft, lumbar
Intervertebral fusion device with bone graft, cervical |
| | Classification Name: | Intervertebral body fusion device
(21 CFR 888.3080) |
| | Regulatory Class:
Product Code: | Class II
MAX, PHM, OVD, ODP |
LEGALLY MARKETED PREDICATE DEVICES III.
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K180480 | PHM, MAX | ATEC Universal Spacer System | Alphatec Spine |
| Additional Predicate Devices | |||
| K182746 | PHM, MAX, OVD | ATEC ALIF and LLIF Spacer System | Alphatec Spine |
| K181435 | ODP | ATEC Cervical Spacer System | Alphatec Spine |
IV. DEVICE DESCRIPTION
The IdentiTi Porous Ti Interbody System is an intervertebral body fusion system implanted from an anterior, anterolateral, lateral or posterior approach. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured from 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
4
Image /page/4/Picture/1 description: The image shows the logo for Atec. The logo consists of a green square with a white "a" inside of it, followed by the word "tec" in white. The background of the logo is a dark blue color.
device. Additionally, the 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 IdentiTi Porous Ti Interbody 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
IdentiTi Cervical Platform
The IdentiTi Porous Ti Interbody 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 IdentiTi Porous Ti Interbody 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.
IdentiTi Thoracolumbar Platform
The IdentiTi Porous Ti Interbody 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 degenerative 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 IdentiTi Porous Ti Interbody 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.
IdentiTi LLIF interbody spacers with >20° lordosis must be used with LLIF AMP integrated fixation in addition to supplemental fixation. IdentiTi ALIF interbody spacers with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.
5
Image /page/5/Picture/1 description: The image shows the logo for Atec. The logo consists of a green square with a white design inside, followed by the word "atec" in white lettering. The background of the logo is a dark blue color. There is a trademark symbol after the word "atec".
TECHNOLOGICAL COMPARISON TO PREDICATES VI.
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 predicate devices supports the design of the subject IdentiTi Porous Ti Interbody System. Additionally, the following testing was performed on the subject interbody implants:
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
The results demonstrate that the subject IdentiTi Porous Ti Interbody 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.