(56 days)
No
The 510(k) summary describes a physical interbody fusion device and its mechanical properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are focused on mechanical and material testing.
Yes
The IdentiTi II Interbody System is indicated for spinal fusion procedures to treat various spinal conditions, aiming to facilitate fusion and provide stability.
No
The device is an interbody system intended for spinal fusion procedures, meaning it is surgically implanted to promote the fusion of vertebrae. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the IdentiTi II Interbody System is an intervertebral body fusion system made from additively manufactured titanium powder and titanium alloy. This indicates it is a physical hardware device intended for surgical implantation.
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 specific conditions.
- Device Description: The description details a physical implant made of titanium, designed to be inserted into the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is an implant used inside the body.
N/A
Intended Use / Indications for Use
The IdentiTiTM II Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the IdentiTi II System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The IdentiTi II Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
AMP™ II Anti-Migration Plate may be used with IdentiTi II LIF interbody spacers to provide integrated fixation. IdentiTi II LIF spacers with >20° lordosis must be used with AMP II Anti-Migration Plate in addition to supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX, PHM, OVD
Device Description
The IdentiTi II Interbody System is a thoracolumbar intervertebral body fusion system designed to be inserted through anterior and posterior surgical approaches. The interbody implants are additively manufactured from titanium powder per ASTM F3001 using a powder bed fusion method. The endplates of the interbody implants contain roughened surface features to mitigate the risk of expulsion. Additionally, the IdentiTi II implants are offered with a microporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The internal lattice structure provides additional space for graft packing. The IdentiTi II LIF implants may be used with the AMP II anti-migration plate and bone screws. The AMP II plate and bone screws are 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
T1 to S1 (thoracolumbar spine)
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)
The following non-clinical testing was performed and included, where appropriate for the design, or referenced in predicate 510(k) submissions to support clearance of the IdentiTi II Interbody System:
- ASTM F2077 static and dynamic axial compression and compression shear
- ASTM F2267 static subsidence
- ASTM F1714 gravimetric analysis
- ASTM F1877 particle analysis
- Static push-out
- ASTM F1854 stereological analysis
- Static screw push-out
- Bacterial endotoxin testing per ANSI/AAMI ST72
Key Results: The results demonstrate that the subject IdentiTi II Interbody 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.
K203714, K223611, K222028, K231438, K222973, K202587, K182746, K180480
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.
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.
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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.
October 4, 2024
Alphatec Spine, Inc. Sandy Gill Manager, Regulatory Affairs 1950 Camino Vida Roble Carlsbad, California 92008
Re: K242364
Trade/Device Name: IdentiTiTM II Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM, OVD Dated: August 8, 2024 Received: August 9, 2024
Dear Sandy Gill:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Brent Showalter -S
Brent Showalter, Ph.D. 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) K242364
Device Name IdentiTi™ II Interbody System
Indications for Use (Describe)
The IdentiTTM II Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the IdentiTi II System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The IdentiTi II Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
AMP™ II Anti-Migration Plate may be used with IdentiTi II LIF interbody spacers to provide integrated fixation. IdentiTi II LIF spacers with >20° lordosis must be used with AMP II Anti-Migration Plate in addition to 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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Image /page/4/Picture/0 description: The image shows the logo for "atec". The "a" is green and the "tec" is 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) 494-6860
Fax: (760) 431-0289 |
|----|-----------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Sandy Gill
Manager, Regulatory Affairs |
Date Summary Prepared:
II. DEVICE
| Trade or Proprietary Name: | IdentiTi™ II Interbody System |
|---|---|
| Common Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral fusion device, lumbar |
| Intervertebral fusion device with integrated fixation, lumbar | |
| Intervertebral fusion device with bone graft, thoracic | |
| Regulation Number: | 21 CFR 888.3080 |
| Classification: | Class II |
| Product Code: | MAX, PHM, OVD |
October 1, 2024
III. LEGALLY MARKETED PREDICATE DEVICES
| Primary Predicate Device: | |||
|---|---|---|---|
| 510(k) | Product Name | Product Code | Clearance Date |
| K203714 | NuVasive Thoracolumbar Interbody | ||
| Systems | MAX, MQV, | ||
| OVD, PHM | December 23, 2021 |
| Additional Predicate Devices: | |||
|---|---|---|---|
| 510(k) | Product Name | Product Code | Clearance Date |
| K223611 | CalibrateTM LTX Interbody System | MAX, PHM, | |
| OVD | March 29, 2023 | ||
| K222028 | IdentiTiTM and TranscendTM Interbody | ||
| Systems | MAX, OVD, | ||
| PHM | October 07, 2022 | ||
| K231438 | CalibrateTM PSX Interbody System | MAX | July 13, 2023 |
| K222973 | IdentiTiTM and TranscendTM Interbody | ||
| Systems | ODP, OVE | September 27, 2022 | |
| K202587 | ATEC Lateral Interbody System | MAX, PHM, | |
| OVD | November 6, 2020 | ||
| K182746 | ATEC ALIF and LLIF Spacer System | MAX, OVD, | |
| PHM | November 27, 2018 | ||
| K180480 | ATEC Universal Spacer System | PHM, MAX | May 31, 2018 |
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Image /page/5/Picture/0 description: The image shows the logo for "atec". The "a" is green and the rest of the letters are dark blue. There is a black line underneath the logo.
| Reference Devices: | |||
|---|---|---|---|
| 510(k) | Product Name | Product Code | Clearance Date |
| K240951 | Invictus™ Robotic Navigation | ||
| Instruments | OLO | June 6, 2024 | |
| K192938 | Invictus™ Spinal Fixation System | NKB, KWP | December 12, 2019 |
| K161363 | Arsenal™ Spinal Fixation System | NKB, KWP, | |
| MNH, MNI, | |||
| OSH | June 10, 2016 |
IV. DEVICE DESCRIPTION
The IdentiTi II Interbody System is a thoracolumbar intervertebral body fusion system designed to be inserted through anterior and posterior surgical approaches. The interbody implants are additively manufactured from titanium powder per ASTM F3001 using a powder bed fusion method. The endplates of the interbody implants contain roughened surface features to mitigate the risk of expulsion. Additionally, the IdentiTi II implants are offered with a microporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The internal lattice structure provides additional space for graft packing. The IdentiTi II LIF implants may be used with the AMP II anti-migration plate and bone screws. The AMP II plate and bone screws are manufactured from titanium alloy per ASTM F136.
V. INDICATIONS FOR USE
The IdentiTi™ II Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the IdentiTi II System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The IdentiTi II Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
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Image /page/6/Picture/0 description: The image shows the logo for "atec". The "a" is green and the "tec" is dark blue. There is a horizontal line underneath the logo.
AMP™ II Anti-Migration Plate may be used with IdentiTi II LIF interbody spacers to provide integrated fixation. IdentiTi II LIF spacers with >20° lordosis must be used with AMP II Anti-Migration Plate in addition to supplemental fixation.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject IdentiTi II Interbody System are substantially equivalent to the primary predicate Nuvasive Thoracolumbar Interbody Systems (K203714), and the additional predicates IdentiTi and Transcend Interbody Systems (K222028), Calibrate LTX Interbody System (K223611), and Invictus Spinal Fixation System (K232275).
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
The following non-clinical testing was performed and included, where appropriate for the design, or referenced in predicate 510(k) submissions to support clearance of the IdentiTi II Interbody System:
- ASTM F2077 static and dynamic axial compression and compression shear ●
- ASTM F2267 static subsidence
- ASTM F1714 gravimetric analysis
- ASTM F1877 particle analysis ●
- Static push-out ●
- ASTM F1854 stereological analysis
- Static screw push-out
- Bacterial endotoxin testing per ANSI/AAMI ST72
The results demonstrate that the subject IdentiTi II Interbody System is substantially equivalent to other predicate devices for nonclinical testing.
CONCLUSION VIII.
Based upon the information provided in this 510(k) submission. it has been determined that the subject device is substantially equivalent to legally marketed devices in regard to indications for use, intended use, design, technology, and performance.