IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System

K211805 · Alphatec Spine, Inc. · MAX · Sep 22, 2021 · Orthopedic

Device Facts

Record IDK211805
Device NameIdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System
ApplicantAlphatec Spine, Inc.
Product CodeMAX · Orthopedic
Decision DateSep 22, 2021
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3080
Device ClassClass 2
AttributesTherapeutic

Intended Use

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. 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 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 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.

Device Story

Interbody fusion system for cervical and thoracolumbar spine; includes PEEK and porous titanium spacers. Implants feature internal graft apertures and endplate teeth for fixation. NanoTec version adds 20-40nm hydroxyapatite surface treatment to enhance topography. Used in spinal fusion procedures via anterior or lateral approaches; requires supplemental fixation (e.g., AMP Anti-Migration Plate for specific LIF spacers). Implants accommodate patient anatomy via various dimensions and lordotic options. Benefits include stabilization of spinal segments and promotion of fusion in DDD patients.

Clinical Evidence

No clinical data; substantial equivalence determination based on bench testing and technological comparison.

Technological Characteristics

Materials: PEEK (ASTM F2026), Tantalum (ASTM F560), Titanium alloy (Ti-6Al-4V ELI), CPTi Grade 2 (ASTM F67), Titanium alloy (ASTM F136). Surface: 20-40nm hydroxyapatite coating. Design: Porous architecture for Ti implants; integrated fixation (AMP) for LIF spacers. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two levels (C2-T1 cervical; T1-L1 thoracic; L1-S1 lumbar). Includes thoracic disc herniation and lumbar spondylolisthesis/retrolisthesis up to Grade I. Requires supplemental fixation and autograft/allograft. Contraindicated for patients without required non-operative treatment duration (6 weeks cervical; 6 months thoracolumbar).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{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) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | # 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.<br>1950 Camino Vida Roble<br>Carlsbad, CA 92008<br>Phone: (760) 431-9286<br>Fax: (760) 431-0289 | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Sandy Gill<br>Regulatory Affairs Specialist<br>Contact Phone: (760) 431-9286 | | Date Summary Prepared: | September 13, 2021 | | II. DEVICE | | | Name of Device: | IdentiTiTM and TranscendTM Interbody Systems:<br>IdentiTiTM Porous Ti Interbody System<br>TranscendTM PEEK Interbody System<br>IdentiTiTM NanoTecTM Interbody System<br>TranscendTM NanoTecTM Interbody System | | Common or Usual Name: | Intervertebral body fusion device | | Classification Name: | Intervertebral fusion device with integrated fixation lumbar<br>Intervertebral fusion device, cervical<br>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,<br>AxTiHA™ Stand-Alone ALIF System | Innovasis, Inc. | | K181435 | ODP | ATEC Cervical Spacer System | Alphatec Spine | | K203201 | MAX, PHM, OVD | CoRoent Thoracolumbar System | NuVasive, Inc. | {8}------------------------------------------------ #### 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. {9}------------------------------------------------ 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 {10}------------------------------------------------ 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. {11}------------------------------------------------ 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 {12}------------------------------------------------ #### 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.
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510(k) Summary
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