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 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.

IdentiTi Porous Ti Interbody System: Intended for spinal fusion procedures at one or two levels from C2-T1 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 allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.

IdentiTi Thoracolumbar Platform: 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 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 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: 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 (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: 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 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 integrated fixation. Transcend-LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.

IdentiTi NanoTec Interbody System: 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: 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 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.

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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding several interbody systems. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting new performance data against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study details, and AI performance is not contained within this document.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" for device performance (e.g., accuracy, sensitivity, specificity) or "reported device performance" against such criteria are provided in this regulatory document. The document focuses on demonstrating substantial equivalence to predicate devices through technological comparison and nonclinical testing.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This document does not describe a study involving a "test set" of patient data for evaluating device performance in terms of diagnostic accuracy or similar metrics. The focus is on demonstrating equivalence through mechanical testing and nonclinical testing for biocompatibility.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth establishment by experts is relevant for studies evaluating diagnostic or prognostic algorithms. This document does not describe such a study.

4. Adjudication Method for the Test Set:

Not applicable. As no test set involving expert review is described, there's no adjudication method mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This document does not mention an MRMC comparative effectiveness study or any evaluation of human readers' improvement with or without AI assistance. The devices are interbody fusion systems, not AI-powered diagnostic tools.

6. Standalone Performance Study:

No. This document describes medical devices (interbody fusion systems) and their material properties and intended use, not an algorithm's standalone performance.

7. Type of Ground Truth Used:

Ground truth in the context of this submission is implicitly established through existing regulatory standards and predicate devices. For mechanical testing, the ground truth is adherence to established engineering standards (e.g., ASTM F2026, ASTM F560, ASTM F67, ASTM F136). For nonclinical testing like Bacterial Endotoxin Testing, the ground truth is compliance with relevant standards (ANSI/AAMI ST72:2011/(R)2016).

8. Sample Size for the Training Set:

Not applicable. This document pertains to physical medical devices, not an AI algorithm that would require a training set.

9. How Ground Truth for the Training Set Was Established:

Not applicable. As there is no AI algorithm or training set, this information is not relevant to the document provided.

Summary of Relevant Information from the Document:

The provided document, K211805, is an FDA 510(k) Premarket Notification. It concerns the substantial equivalence of several interbody fusion devices (IdentiTi™ Porous Ti Interbody System, Transcend™ PEEK Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ NanoTec™ Interbody System) to legally marketed predicate devices.

Acceptance Criteria and Device Performance: The primary "acceptance criterion" for this submission is demonstrating substantial equivalence to predicate devices. The "performance" assessment is based on:
- Technological Comparison: Comparing intended use, indications for use, design, function, and technology to predicate devices. The document states that the new devices are "substantially equivalent" in these aspects.
- Nonclinical Testing: Mechanical testing and Bacterial Endotoxin Testing (BET) were performed.
  - Mechanical Testing: Performed on the predicates and deemed applicable to the modified devices because there are "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." This implies that the mechanical performance (e.g., strength, durability) is considered equivalent to the predicate that has already met its mechanical performance requirements.
  - Bacterial Endotoxin Testing (BET): Performed per ANSI/AAMI ST72:2011/(R)2016. The results demonstrate that the subject systems are substantially equivalent to other predicate devices for nonclinical testing.
Study That Proves the Device Meets Acceptance Criteria:
- The study primarily involves a technical comparison and nonclinical laboratory testing. No clinical studies are mentioned.
- Sample sizes: Not specified for mechanical or BET testing, as these are typically conducted on a limited number of representative samples, not human patient "test sets."
- Data provenance: Not explicitly stated, but nonclinical testing is typically performed in a controlled laboratory environment (e.g., in the US, where Alphatec Spine is based). This is not retrospective or prospective patient data.
- Experts: Not applicable for nonclinical lab testing.
- Adjudication method: Not applicable.
- MRMC Comparative Effectiveness Study: Not conducted.
- Standalone Performance: The "standalone performance" is implicitly demonstrated through the nonclinical testing showing compliance with applicable standards and the assertion of substantial equivalence in design and materials compared to already cleared devices.
- Ground Truth: For mechanical aspects, the ground truth is assumed to be met by the predicate devices adhering to established ASTM standards. For biocompatibility (BET), the ground truth is compliance with ANSI/AAMI ST72:2011/(R)2016.
- Training Set Sample Size and Ground Truth Establishment: Not applicable as this is not an AI-based device.

Summary

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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.

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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

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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.

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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).

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.

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.

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.

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 RobleCarlsbad, CA 92008Phone: (760) 431-9286Fax: (760) 431-0289
Contact Person:	Sandy GillRegulatory Affairs SpecialistContact Phone: (760) 431-9286
Date Summary Prepared:	September 13, 2021
II. DEVICE
Name of Device:	IdentiTiTM and TranscendTM Interbody Systems:IdentiTiTM Porous Ti Interbody SystemTranscendTM PEEK Interbody SystemIdentiTiTM NanoTecTM Interbody SystemTranscendTM NanoTecTM Interbody System
Common or Usual Name:	Intervertebral body fusion device
Classification Name:	Intervertebral fusion device with integrated fixation lumbarIntervertebral fusion device, cervicalIntervertebral 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 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.

The IdentiTi Porous Ti Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

IdentiTi 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

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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.

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.

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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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

Transcend NanoTec Thoracolumbar Platform

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.

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.

Regulation Number and Section

§ 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.