(103 days)
Not Found
No
The document describes physical interbody fusion devices and their materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device, an intervertebral body fusion system, is intended for spinal fusion procedures to treat degenerative disc disease, aiming to alleviate pain and stabilize the spine. This clearly fits the definition of a therapeutic device as it treats a specific medical condition.
No
The device is described as an intervertebral body fusion system intended for spinal fusion procedures, which is a therapeutic treatment, not a diagnostic one.
No
The device description clearly states that the device is a physical interbody fusion system made from materials like PEEK, tantalum, and titanium alloy, and includes physical components like spacers, plates, and screws. It is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for spinal fusion procedures in skeletally mature patients with degenerative disc disease. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details the materials and design of interbody spacers and fixation plates which are implanted into the spine.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with patient specimens outside of the body.
The device described is a surgical implant used in spinal procedures, not an IVD.
N/A
Intended Use / Indications for Use
Transcend NanoTec Cervical Platform
The Transcend PEEK Cervical Interbody System with advanced NanoTec surface treatment 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 Transcend PEEK Cervical NanoTec Interbody System is intended for use with supplemental fixation systems and with autograft or allograft (e.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients should have had six weeks of non-operative treatment.
Transcend NanoTec Thoracolumbar Platform
The Transcend PEEK Interbody System with advanced NanoTec surface treatment 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 discectory for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc hemiation (myelopathy with or without axial pain).
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 Transcend NanoTec PEEK Interbody System is intended for use on patients who have had at least six months of nonoverative treatment. It is intended for use with autograft 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.
AMP Anti-Migration Plate may be used with Transcend NanoTec-LIF interbody spacers to provide integrated fixation. Transcend NanoTec-LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.
IdentiTi Porous Ti Interbody System
IdentiTi Cervical Platform
The IdentiTi Cervical Porous Ti Interbody System is intended for spinal fusion procedures at one or two levels from C2-T in skeletally mature patients with degenerative 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 Cervical Porous Ti Interbody System is intended for use with supplemental fixation systems and with autograft and/or allografi 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 hemiation (myelopathy with or without axial pain).
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 nonoverative treatment. It is intended for use with autograft 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.
AMP Anti-Migration Plate may be used with IdentiTi-LIF interbody spacers to provide integrated fixation. IdentiTi-LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.
Transcend PEEK Interbody System
Transcend Cervical Platform
The Transcend PEEK Cervical 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 Transcend PEEK Cervical Interbody System is intended for use with supplemental fixation systems and with autograft (c.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients should have had six weeks of non-operative treatment.
Transcend Thoracolumbar Platform
The Transcend PEEK Interbody System is indicated for spinal fusion procedures in sketally 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 hemiation (myelopathy with or without axial pain).
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 Transcend PEEK 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 bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
AMP Anti-Migration Plate may be used with Transcend-LIF interbody spacers to provide interrated fixation. Transcend-LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.
IdentiTi™ NanoTec™ Interbody System
IdentiTi NanoTec Cervical Platform
The IdentiTi Cervical Interbody System with advanced NanoTec surface treatment 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 Cervical NanoTec 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 NanoTec Thoracolumbar Platform
The IdentiTi Interbody System with advanced NanoTec surface treatment 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 discectory for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc hemiation (myelopathy with or without axial pain).
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 NanoTec 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.
AMP Anti-Migration Plate may be used with IdentiTi NanoTec-LIF interbody spacers to provide integrated fixation. IdentiTi NanoTec-LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD, ODP, PHM
Device Description
The IdentiTi and Transcend Interbody Systems are cervical and thoracolumbar intervertebral body fusion systems designed to be inserted through anterior and lateral surgical approaches. The interbody spacers are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, titanium alloy (Ti-6Al-4V ELI), and commercially pure titanium (CPTi Grade 2) per ASTM F67. The interbody spacers are available in the following material options: (1) PEEK (polyetheretherketone) with tantalum and titanium alloy markers, or (2) commercially pure porous titanium (PTi).
The subject IdentiTi and Transcend Interbody Systems implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. To mitigate risk of expulsion, the interbody endplates feature teeth. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. Additionally, the IdentiTi implants are offered with a microstructure due to the layering of material that forms the porous architecture. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation.
The IdentiTi and Transcend NanoTec interbody implant surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.
The IdentiTi and Transcend Interbody Systems also includes LIF AMP integrated fixation to be used with the LIF interbody offerings. The LIF 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), Thoracic spine (T1-T2 to T11-T12), thoracolumbar junction (T12-L1), Lumbar spine (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)
Mechanical testing performed on the predicates applies to the modified devices because there is no difference in size. dimension, raw material or manufacturing method or equipment with the exception of a nanometer thin layer of hydroxyapatite applied to the surface.
Nonclinical testing performed on the IdentiTi and Transcend Interbody Systems supports substantial equivalence to other predicate devices. The following testing was performed:
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
The results demonstrate that the subject IdentiTi and Transcend Interbody Systems are 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.
K183705, K202587, K201614, K181435, K203201
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 the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 22, 2021
Alphatec Spine, Inc. Ms. Sandy Gill Regulatory Affairs Specialist 1950 Camino Vida Roble Carlsbad, California 92008
Re: K211805
Trade/Device Name: IdentiTi™ Porous Ti Interbody System, Transcend™ PEEK Interbody System, IdentiTiTM NanoTecTM Interbody System, Transcend™ NanoTecTM Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD, ODP, PHM Dated: August 25, 2021 Received: August 26, 2021
Dear Ms. 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 (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.
1
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 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,
Brent L. 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
2
510(k) Number (if known) K211805
Device Name Transcend™ NanoTec™ Interbody System
Indications for Use (Describe)
Transcend NanoTec Cervical Platform
The Transcend PEEK Cervical Interbody System with advanced NanoTec surface treatment 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 Transcend PEEK Cervical NanoTec Interbody System is intended for use with supplemental fixation systems and with autograft or allograft (e.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients should have had six weeks of non-operative treatment.
Transcend NanoTec Thoracolumbar Platform
The Transcend PEEK Interbody System with advanced NanoTec surface treatment 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 discectory for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc hemiation (myelopathy with or without axial pain).
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 Transcend NanoTec PEEK Interbody System is intended for use on patients who have had at least six months of nonoverative treatment. It is intended for use with autograft 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.
AMP Anti-Migration Plate may be used with Transcend NanoTec-LIF interbody spacers to provide integrated fixation. Transcend NanoTec-LIF spacers with >20° lordosis must be used with AMP 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) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
510(k) Number (if known) K211805
Device Name IdentiTiTM Porous Ti Interbody System
Indications for Use (Describe)
IdentiTi Cervical Platform
The IdentiTi Cervical Porous Ti Interbody System is intended for spinal fusion procedures at one or two levels from C2-T in skeletally mature patients with degenerative 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 Cervical Porous Ti Interbody System is intended for use with supplemental fixation systems and with autograft and/or allografi 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 hemiation (myelopathy with or without axial pain).
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 nonoverative treatment. It is intended for use with autograft 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.
AMP Anti-Migration Plate may be used with IdentiTi-LIF interbody spacers to provide integrated fixation. IdentiTi-LIF spacers with >20° lordosis must be used with AMP 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services
Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K211805
Device Name Transcend™ PEEK Interbody System
Indications for Use (Describe)
Transcend Cervical Platform
The Transcend PEEK Cervical 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 Transcend PEEK Cervical Interbody System is intended for use with supplemental fixation systems and with autograft (c.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients should have had six weeks of non-operative treatment.
Transcend Thoracolumbar Platform
The Transcend PEEK Interbody System is indicated for spinal fusion procedures in sketally 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 hemiation (myelopathy with or without axial pain).
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 Transcend PEEK 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 bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
AMP Anti-Migration Plate may be used with Transcend-LIF interbody spacers to provide interrated fixation. Transcend-LIF spacers with >20° lordosis must be used with AMP 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known) K211805
Device Name IdentiTi™ NanoTec™ Interbody System
Indications for Use (Describe)
IdentiTi NanoTec Cervical Platform
The IdentiTi Cervical Interbody System with advanced NanoTec surface treatment 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 Cervical NanoTec 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 NanoTec Thoracolumbar Platform
The IdentiTi Interbody System with advanced NanoTec surface treatment 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 discectory for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc hemiation (myelopathy with or without axial pain).
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 NanoTec 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.
AMP Anti-Migration Plate may be used with IdentiTi NanoTec-LIF interbody spacers to provide integrated fixation. IdentiTi NanoTec-LIF spacers with >20° lordosis must be used with AMP 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
Image /page/7/Picture/0 description: The image shows the logo for "atec". The "a" is green and the rest of the letters are a dark blue. There is a trademark symbol to the right of the "c". There is a black line underneath the logo.
K211805 510K Summary
| I. SUBMITTER: | Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sandy Gill
Regulatory Affairs Specialist
Contact Phone: (760) 431-9286 |
| Date Summary Prepared: | September 13, 2021 |
| II. DEVICE | |
| Name of Device: | IdentiTiTM and TranscendTM Interbody Systems:
IdentiTiTM Porous Ti Interbody System
TranscendTM PEEK Interbody System
IdentiTiTM NanoTecTM Interbody System
TranscendTM NanoTecTM Interbody System |
| Common or Usual Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral fusion device with integrated fixation lumbar
Intervertebral fusion device, cervical
Intervertebral fusion device, lumbar |
| Regulatory Class: | Class II |
| Product Code: | MAX, ODP, OVD, PHM |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K183705 | PHM, MAX, OVD | IdentiTi Porous Ti Interbody System | Alphatec Spine |
| Additional Predicate Devices | |||
| K202587 | MAX, OVD, PHM | ATEC Lateral Interbody System | Alphatec Spine |
| K201614 | MAX, OVD | TxTiHA™ IBF System, | |
| AxTiHA™ Stand-Alone ALIF System | Innovasis, Inc. | ||
| K181435 | ODP | ATEC Cervical Spacer System | Alphatec Spine |
| K203201 | MAX, PHM, OVD | CoRoent Thoracolumbar System | NuVasive, Inc. |
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IV. DEVICE DESCRIPTION
The IdentiTi and Transcend Interbody Systems are cervical and thoracolumbar intervertebral body fusion systems designed to be inserted through anterior and lateral surgical approaches. The interbody spacers are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, titanium alloy (Ti-6Al-4V ELI), and commercially pure titanium (CPTi Grade 2) per ASTM F67. The interbody spacers are available in the following material options: (1) PEEK (polyetheretherketone) with tantalum and titanium alloy markers, or (2) commercially pure porous titanium (PTi).
The subject IdentiTi and Transcend Interbody Systems implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. To mitigate risk of expulsion, the interbody endplates feature teeth. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. Additionally, the IdentiTi implants are offered with a microstructure due to the layering of material that forms the porous architecture. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation.
The IdentiTi and Transcend NanoTec interbody implant surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.
The IdentiTi and Transcend Interbody Systems also includes LIF AMP integrated fixation to be used with the LIF interbody offerings. The LIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136.
V. INDICATIONS FOR USE
IdentiTi Porous Ti Interbody System
IdentiTi Cervical Platform
The IdentiTi Cervical 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 Cervical 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.
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Image /page/9/Picture/0 description: The image shows the word "atec" in a stylized font. The "a" is green, while the "tec" is dark blue. There is a trademark symbol to the right of the "c". A black line is underneath the word.
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).
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.
AMP Anti-Migration Plate may be used with IdentiTi-LIF interbody spacers to provide integrated fixation. IdentiTi-LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.
IdentiTi NanoTec Interbody System
IdentiTi NanoTec Cervical Platform
The IdentiTi Cervical Interbody System with advanced NanoTec surface treatment 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 Cervical NanoTec Interbody System is intended for use with supplemental fixation systems and with autograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of nonoperative treatment.
IdentiTi NanoTec Thoracolumbar Platform
The IdentiTi Interbody System with advanced NanoTec surface treatment 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
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Image /page/10/Picture/0 description: The image shows the word "atec" in a stylized font. The "a" is green, while the "tec" is dark blue. There is a horizontal line underneath the word. The letters are connected and have a modern, sleek appearance.
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 NanoTec 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.
AMP Anti-Migration Plate may be used with IdentiTi NanoTec-LIF interbody spacers to provide integrated fixation. IdentiTi NanoTec-LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.
Transcend PEEK Interbody System
Transcend Cervical Platform
The Transcend PEEK Cervical 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 Transcend PEEK Cervical Interbody System is intended for use with supplemental fixation systems and with autograft or allograft (e.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients should have had six weeks of non-operative treatment.
Transcend Thoracolumbar Platform
The Transcend PEEK 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).
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 Transcend PEEK 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.
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Image /page/11/Picture/0 description: The image shows the logo for "atec". The "a" is green, and the rest of the letters are a dark blue. There is a horizontal black line underneath the logo. The logo is simple and modern.
AMP Anti-Migration Plate may be used with Transcend-LIF interbody spacers to provide integrated fixation. Transcend-LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.
Transcend NanoTec Interbody System
Transcend NanoTec Cervical Platform
The Transcend PEEK Cervical Interbody System with advanced NanoTec surface treatment 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 Transcend PEEK Cervical NanoTec Interbody System is intended for use with supplemental fixation systems and with autograft or allograft (e.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients should have had six weeks of non-operative treatment.
Transcend NanoTec Thoracolumbar Platform
The Transcend PEEK Interbody System with advanced NanoTec surface treatment 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).
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 Transcend NanoTec PEEK 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.
AMP Anti-Migration Plate may be used with Transcend NanoTec-LIF interbody spacers to provide integrated fixation. Transcend NanoTec-LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.
K211805 510(k) Summary Page 5 of 6
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VI. TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES
The subject IdentiTi and Transcend NanoTec Interbody Systems incorporate a nano-scale hydroxyapatite surface treatment, identical to that provided on devices cleared in TxTiHA™ IBF System, AxTiHA™ Stand-Alone ALIF System (K201614). The subject IdentiTi and Transcend NanoTec implants are a line extension to primary predicate, IdentiTi Porous Ti Interbody System (K183705) and additional predicate devices: ATEC Lateral Interbody System (K202587) and ATEC Cervical Spacer System (K181435). Additionally, the indications for use have been updated to remove the limitation on the lateral approach. The indications for use are substantially equivalent to predicate devices.
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
Mechanical testing performed on the predicates applies to the modified devices because there is no difference in size. dimension, raw material or manufacturing method or equipment with the exception of a nanometer thin layer of hydroxyapatite applied to the surface.
Nonclinical testing performed on the IdentiTi and Transcend Interbody Systems supports substantial equivalence to other predicate devices. The following testing was performed:
- . Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
The results demonstrate that the subject IdentiTi and Transcend Interbody Systems are 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.
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.