The IdentiTi ALIF Standalone Interbody System is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

Additionally, the IdentiTi ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the IdentiTi ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The IdentiTi ALIF Standalone Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

When used with three integrated screws, the IdentiTi ALIF Standalone Interbody System implants of <20° are a standalone system. When used with fewer than three integrated screws, and for interbody implants of >20°, the IdentiTi ALIF Standalone Interbody System implants must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

The IdentiTi Porous Ti Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the IdentiTi Porous Ti Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The IdentiTi Porous Ti Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate and supplemental fixation systems, regardless of the use of integrated fixation, that are cleared by FDA for use in the thoracic and lumbar spine.

Device Description

The subject IdentiTi ALIF Interbody Systems are inclusive of IdentiTi ALIF Standalone Interbody System. IdentiTi ALIF Oblique Interbody System, and IdentiTi ALIF Narrow Interbody System. IdentiTi ALIF Oblique and Narrow interbody systems are subsystems of the Alphatec IdentiTi Porous Ti Interbody System.

IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device with integrated screw fixation for use in anterior and anterolateral procedures. The IdentiTi ALIF Standalone Interbody System consist of interbody devices and bone screw(s) in multiple configurations to accommodate individual patient anatomy. The IdentiTi ALIF Standalone Interbody System interbody spacers are manufactured from a combination of commercially pure porous titanium (CP Ti Grade 2) per ASTM F67 and titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The IdentiTi ALIF Standalone Interbody System interbody spacers are provided in multiple footprints with varying lengths, widths, heights, and angles of lordosis to accommodate individual patient anatomy. The interbody spacers accept three bone screws that are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters.

The IdentiTi ALIF Standalone Interbody System implants of <20° are a standalone system. The IdentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

The IdentiTi Porous Ti Interbody System is an intervertebral body fusion device with implants of various lengths, widths, heights, and degrees of lordosis to accommodate individual patient anatomy. The IdentiTi interbody spacers are manufactured from commercially pure titanium Grade 2 per ASTM F67 and titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The IdentiTi Porous Ti thoracolumbar platform includes the following sub-systems: IdentiTi ALIF, IdentiTi ALIF Oblique, IdentiTi ALIF Narrow.

The IdentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

The purpose of this 510(k) submission is to receive clearance for new IdentiTi ALIF Oblique and Narrow interbody implants, modified graft bolts for use with standard IdentiTi ALIF SA interbody implants, and new Class II instruments.

AI/ML Overview

The provided text is a 510(k) summary for the IdentiTi ALIF Interbody Systems. This document pertains to the regulatory clearance of a medical device and does not describe a study involving device performance against acceptance criteria in the context of diagnostic or AI-driven systems.

Instead, this document outlines the nonclinical testing performed on the interbody systems to support their substantial equivalence to predicate devices, thus ensuring their safety and effectiveness for their intended use. The "performance data" section refers to mechanical and material testing, not clinical studies on human or AI performance.

Therefore, I cannot provide information on:

A table of acceptance criteria and the reported device performance: The document does not define such criteria nor report performance in a way that would fit this table for a diagnostic device. It lists mechanical tests.
Sample size used for the test set and the data provenance: Not applicable for this type of mechanical testing.
Number of experts used to establish the ground truth: Not applicable.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is not a diagnostic device.
Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable as this is not an algorithm or AI.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

However, I can extract the information related to the nonclinical performance data that was conducted:

1. Nonclinical Performance Data

The performance data section in the document describes a series of nonclinical mechanical tests performed on the IdentiTi™ ALIF Interbody Systems to support their substantial equivalence to predicate devices. These tests evaluate the device's material properties and mechanical integrity.

Acceptance Criteria (Implied by ASTM Standards)	Reported Device Performance
Material & Mechanical Integrity
ASTM F2077 static & dynamic axial compression	Supported substantial equivalence to predicate devices
ASTM F2077 static & dynamic compression-shear	Supported substantial equivalence to predicate devices
ASTM F2077 Dynamic Compression-shear Confirmation (30° Spacer)	Supported substantial equivalence to predicate devices
ASTM F1714 Gravimetric Analysis (endplate integrity)	Supported substantial equivalence to predicate devices
ASTM F1877 Particulate Analysis (endplate integrity)	Supported substantial equivalence to predicate devices
ASTM F2267 Static Subsidence	Supported substantial equivalence to predicate devices
Static Push-out (20° Spacer)	Supported substantial equivalence to predicate devices
Static Screw Push-out	Supported substantial equivalence to predicate devices
Graft Aperture Area Analysis	Supported substantial equivalence to predicate devices
ASTM F543 Static Torsion	Supported substantial equivalence to predicate devices
ASTM F2193 Static Cantilever Bend	Supported substantial equivalence to predicate devices

Study Proving Device Meets Acceptance Criteria:

The study referenced in the document is a series of nonclinical mechanical and material tests performed on the IdentiTi™ ALIF Interbody Systems. The specific results of these tests (e.g., exact load values, deformation measurements) are not detailed in this 510(k) summary but are summarized as demonstrating "substantial equivalence to the predicate devices."

The "acceptance criteria" for these tests are implicitly the requirements and expected performance outlined within the referenced ASTM (American Society for Testing and Materials) standards. For a 510(k) submission, meeting these standards and demonstrating equivalence to a legally marketed predicate device (which has already proven its safety and effectiveness) is the primary method of proving the device meets regulatory requirements.

Additional Information from the Document (where applicable):

Data Provenance: The data would be from laboratory testing performed by Alphatec Spine, Inc. or a contracted testing facility. It is inherently "prospective" in the sense that the tests are designed and executed to evaluate the new device.
Ground Truth Type: For mechanical testing, the "ground truth" is defined by the physical properties of the materials and the mechanical performance under applied conditions as measured by calibrated equipment according to established ASTM standards.
Clinical Information: The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This means no human clinical study was conducted or relied upon for this 510(k) clearance.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 25, 2023

Alphatec Spine, Inc. Andrew Zhang Specialist, Regulatory Affairs 1950 Camino Vida Roble Carlsbad, California 92008

Re: K232097

Trade/Device Name: IdentiTi Interbody Systems Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX. OVD Dated: July 13, 2023 Received: July 13, 2023

Dear Mr. Zhang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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 Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K232097

Device Name IdentiTiTM ALIF Standalone Interbody System

Indications for Use (Describe)

The IdentiTi ALIF Standalone Interbody System is indicated for spinal fusion procedures from L2 to S1 in sketally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

When used with three integrated screws, the IdentiTi ALIF Standalone Interbody System implants of _20° are a standalone system. When used with fewer than three integrated screws, and for interbody implants of >20°, the IdentiTi ALIF Standalone Interbody System implants must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Indications for Use

510(k) Number (if known) K232097

Device Name IdentiTi Porous Ti Interbody System

Indications for Use (Describe)

The IdentiTi Porous Ti Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondy lolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the IdentiTi Porous Ti Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K232097 510(k) Summary

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

I.	SUBMITTER:	Alphatec Spine, Inc.1950 Camino Vida RobleCarlsbad, CA 92008Phone: (760) 431-6884Fax: (760) 431-0289
	Contact Person:	Andrew ZhangSpecialist, Regulatory AffairsContact Phone: (760) 494-6806
	Date Summary Prepared:	August 11, 2023
II.	DEVICE
	Name of Device:	IdentiTi ALIF Interbody Systems:IdentiTi™ ALIF Standalone Interbody SystemIdentiTi™ ALIF Oblique Interbody SystemIdentiTi™ ALIF Narrow Interbody System
	Common or Usual Name:Classification Name:	Intervertebral Body Fusion DeviceIntervertebral Fusion Device with IntegratedFixation, LumbarIntervertebral Fusion Device, Lumbar
	Regulation Number:Regulatory Class:Product Code:	21 CFR 888.3080Class IIMAX, OVD

III. LEGALLY MARKETED PREDICATE DEVICES

510(k)	ProductCode	Trade Name	Manufacturer	ClearanceDate
Primary Predicate Device
K222028	MAX,OVD, PHM	IdentiTi™ Porous Ti Interbody System,IdentiTi™ NanoTec™ Interbody System,Transcend™ PEEK Interbody System,Transcend™ NanoTec™ InterbodySystem, IdentiTi™ ALIF StandaloneInterbody System, IdentiTi™ NanoTec™ALIF Standalone Interbody System	Alphatec Spine	10/7/2022
Additional Predicate Devices
K180480	MAX, PHM	ATEC Universal Spacer System	Alphatec Spine	5/31/2018

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IV. DEVICE DESCRIPTION

The IdentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

V. INDICATIONS FOR USE

IdentiTi ALIF SA Interbody System

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disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

Additionally, the IdentiTi ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondvlolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the IdentiTi ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The IdentiTi ALIF Standalone lnterbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

IdentiTi Porous Ti Interbody System (inclusive of IdentiTi ALIF Oblique and Narrow Interbody Systems):

The IdentiTi Porous Ti Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the IdentiTi Porous Ti Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

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 to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate and supplemental fixation systems, regardless of the use of integrated fixation, that are cleared by FDA for use in the thoracic and lumbar spine.

VI. TECHNOLOGICAL COMPARISON TO PREDICATES

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.

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VII. PERFORMANCE DATA

Nonclinical testing performed on the IdentiTiTM ALIF Interbody Systems support substantial equivalence to the predicate devices. The following testing/analysis was performed:

ASTM F2077 static & dynamic axial compression, static & dynamic ● compression-shear
ASTM F2077 Dynamic Compression-shear Confirmation (30° Spacer).
ASTM F1714 Gravimetric Analysis (endplate integrity), ●
ASTM F1877 Particulate Analysis (endplate integrity), ●
ASTM F2267 Static Subsidence,
Static Push-out (20° Spacer),
Static Screw Push-out,
Graft Aperture Area Analysis, ●
ASTM F543 Static Torsion, ●
ASTM F2193 Static Cantilever Bend ●

The results demonstrate that the proposed IdentiTi™ ALIF Interbody Systems are substantially equivalent to the 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 the 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.