The IdentiTi™ II Cervical Interbody System is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi II Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

Device Description

The IdentiTi II Cervical Interbody System is a cervical intervertebral body fusion system designed to be inserted through an anterior surgical approach. The interbody implants are additively manufactured from titanium powder per ASTM F3001 using a powder bed fusion method. The IdentiTi II Cervical Interbody System includes the following subsystems: IdentiTi II Cervical and IdentiTi II Cervical Max Contact. The endplates of the interbody implants contain roughened surface features to mitigate the risk of expulsion. Additionally, the IdentiTi II Cervical implants are offered with a microporous/macroporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The internal lattice structure provides additional space for graft packing.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary concern the IdentiTi II Cervical Interbody System, which is a medical device for spinal fusion. This document does not describe an AI/ML-based medical device. Therefore, it does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as typically required for AI/ML device clearances.

The performance data section (VII. PERFORMANCE DATA) specifically lists non-clinical testing for mechanical properties, material properties, and biocompatibility, as is standard for intervertebral body fusion devices. These tests include:

ASTM F2077 static and dynamic axial compression, compression shear and torsion
ASTM F2267 static subsidence
ASTM F1714 gravimetric analysis
ASTM F1877 particle analysis
Static push-out
ASTM F1854 stereological analysis
Bacterial endotoxin testing per ANSI/AAMI ST72

Since the request is to "describe the acceptance criteria and the study that proves the device meets the acceptance criteria" as if it were an AI/ML device, and the provided text explicitly indicates it is a non-AI/ML medical device, I cannot fulfill the request directly with the given input. The information points to a traditional medical device clearance, not an AI/ML one.

To answer your question based on the provided document, I must state that the information requested (acceptance criteria for AI/ML performance, study details for AI/ML, human expert consensus, etc.) is not present because the device described is a physical intervertebral body fusion system, not an AI/ML algorithm.

The document confirms that this device is a Class II medical device (Product Code ODP: Intervertebral Body Fusion Device), and its clearance is based on substantial equivalence to predicate devices through engineering and material testing, not through AI/ML performance evaluation.

Summary

FDA 510(k) Clearance Letter - IdentiTi II Cervical Interbody System

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 3, 2025

Alphatec Spine, Inc.
Unnati Bhuptani
Manager, Regulatory Affairs
1950 Camino Vida Roble
Carlsbad, California 92008

Re: K251080
Trade/Device Name: IdentiTi II Cervical Interbody System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: ODP
Dated: April 8, 2025
Received: April 8, 2025

Dear Unnati Bhuptani:

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

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K251080 - Unnati Bhuptani Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K251080 - Unnati Bhuptani Page 3

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K251080

Device Name: IdentiTi™ II Cervical Interbody System

Indications for Use (Describe)

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
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Paperwork Reduction Act (PRA) Staff
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"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."

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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K251080
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This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

I. SUBMITTER:

Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad, CA 92008
Phone: (760) 494-6860
Fax: (760) 431-0289

Contact Person: Unnati Bhuptani
Manager, Regulatory Affairs

Date Summary Prepared: April 7, 2025

II. DEVICE

Trade or Proprietary Name: IdentiTi™ II Cervical Interbody System
Common Name: Intervertebral body fusion device
Classification Name: Intervertebral fusion device with Bone Graft, Cervical
Regulation Number: 21 CFR 888.3080
Classification: Class II
Product Code: ODP

III. LEGALLY MARKETED PREDICATE DEVICES

Primary Predicate Device:

510(k)	Product Name	Product Code	Clearance Date
K241375	IdentiTi™ and Transcend™ Interbody Systems	MAX, ODP, OVD, OVE PHM	February 02, 2025

Additional Predicate Devices:

510(k)	Product Name	Product Code	Clearance Date
K242364	IdentiTi II Interbody System	MAX, PHM, OVD	October 04, 2024
K151496	Latitude-C Cervical Interbody Spacer System	ODP	December 15, 2015
K150362	NuVasive CoRoent Small Interbody System	ODP	June 11, 2015
K120603	Varilift-C	ODP	January 29, 2013

Reference Devices:

510(k)	Product Name	Product Code	Clearance Date
K192938	Invictus™ Spinal Fixation System	NKB, KWP	December 12, 2019

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K251080
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510(k)	Product Name	Product Code	Clearance Date
K232275	Invictus™ Spinal Fixation System	NKB, KWP, KWQ, OUR, PML	September 27, 2023
K161363	Arsenal Spinal Fixation System	NKB, KWP, MNH, MNI, OSH	June 10, 2016

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

VI. TECHNOLOGICAL COMPARISON TO PREDICATES

The technological design features of the subject IdentiTi II Cervical Interbody System are substantially equivalent to the primary predicate IdentiTi and Transcend Interbody Systems (K241375) and the additional predicates IdentiTi II Interbody Systems (K242364) and Latitude-C Cervical Interbody Spacer System (K151496).

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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K251080
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VII. PERFORMANCE DATA

The following non-clinical testing was performed and included, where appropriate for the design, or referenced in predicate 510(k) submissions to support clearance of the IdentiTi II Cervical Interbody System:

ASTM F2077 static and dynamic axial compression, compression shear and torsion
ASTM F2267 static subsidence
ASTM F1714 gravimetric analysis
ASTM F1877 particle analysis
Static push-out
ASTM F1854 stereological analysis
Bacterial endotoxin testing per ANSI/AAMI ST72

The results demonstrate that the subject IdentiTi II Cervical Interbody System is substantially equivalent to other predicate devices for nonclinical testing.

VIII. CONCLUSION

Based upon the information provided in this 510(k) submission, it has been determined that the subject device is substantially equivalent to legally marketed devices in regard to indications for use, intended use, design, technology, and performance.

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.