The ATEC Universal Spacer 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 degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.

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 ATEC Universal Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with allograft (e.g., Allogenic bone graft composed of cancellous and/or corticocancellous bone graft) and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Device Description

ATEC Universal Spacer System includes the Battalion Universal Spacer System and Porous Ti Spacer System.

The Battalion Universal Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants come in three material varieties: polyetheretherketone with tantalum markers, commercially pure titanium coated polyetheretherketone with tantalum markers, and titanium alloy (Ti-6Al-4V ELI). The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device.

The Porous Ti Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are made of a commercially pure porous titanium (PTi). The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally, the PTi implant is offered with a microstructure due to the layering of material that forms the porous geometry. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation.

All materials are of surgical grade; polyetheretherketone (PEEK Optima LT1) conforms to ASTM F2026, tantalum conforms to ASTM F560, titanium coating conforms to ASTM F1580, the titanium alloy (Ti-6Al-4V ELI) conforms to ASTM F136, and the commercially pure titanium conforms to ASTM F67. All implants will be provided sterile.

AI/ML Overview

The provided text is a 510(k) Summary for the ATEC Universal Spacer System, a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It's crucial to understand that this document describes the device itself and its substantial equivalence to other legally marketed devices, not an AI/ML algorithm or software device. Therefore, the requested information pertaining to acceptance criteria for an AI device, sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, training sets, or how ground truth was established for a training set, is not applicable to this document.

The document focuses on the mechanical and material performance of the ATEC Universal Spacer System.

Here's the relevant information that can be extracted:

1. A table of acceptance criteria and the reported device performance:

The document lists performance data and engineering analyses that support the substantial equivalence of the ATEC Universal Spacer System. While specific acceptance criteria values are not explicitly stated in this summary, the types of tests conducted imply that the device met the standards defined within the referenced ASTM specifications.

Test Type	Standard/Method	Reported Performance
Static Compression	ASTM F2077	Demonstrated substantial equivalence to predicates.
Dynamic Compression	ASTM F2077	Demonstrated substantial equivalence to predicates.
Static Compression Shear	ASTM F2077	Demonstrated substantial equivalence to predicates.
Dynamic Compression Shear	ASTM F2077	Demonstrated substantial equivalence to predicates.
Gravimetric and Particulate analysis	ASTM F1714 and F1877	Demonstrated substantial equivalence to predicates.
Push-out	ASTM F04-25-02-02 Draft	Demonstrated substantial equivalence to predicates.
Subsidence	ASTM F2267	Demonstrated substantial equivalence to predicates.
Bacterial Endotoxin Testing (BET)	ANSI/AAMI ST72:2011/(R)2016	Demonstrated substantial equivalence to predicates.

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, and the testing involves mechanical and material properties, not an AI test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical device's mechanical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device's mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device. The document explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for the mechanical and material tests performed on a physical device. The "ground truth" for these tests would be the established scientific and engineering principles and the specifications within the referenced ASTM standards themselves.

8. The sample size for the training set: Not applicable. This is not an AI device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary

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May 31, 2018

Alphatec Spine, Inc Jeremy Markovich Senior Manager, Regulatory and Clinical Affairs 5818 El Camino Real Carlsbad, California 92008

Re: K180480

Trade/Device Name: ATEC Universal Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, PHM Dated: May 3, 2018 Received: May 4, 2018

Dear Mr. Markovich:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180480

Device Name ATEC Universal Spacer System

Indications for Use (Describe)

The ATEC Universal Spacer 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 degeneration disc disease (DDD), including thoracic disc herniation (myelopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.

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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Image /page/3/Picture/0 description: The image shows the logo for ATEC. The logo features a green square with a stylized white "a" inside of it. To the right of the square is the word "tec" in white, lowercase letters. The background of the logo is a dark blue color.

510(k) Summary

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. The assigned 510(k) number is K180480.

I.	SUBMITTER:	Alphatec Spine, Inc.5818 El Camino RealCarlsbad, CA 92008Phone: (760) 431-9286Fax: (760) 431-0289
	Contact Person:	Jeremy MarkovichSenior Manager, Regulatory and Clinical AffairsContact Phone: (760) 494-6893
	Date Summary Prepared:	February 22, 2018

II. DEVICE

Name of Device:	ATEC Universal Spacer System
Common or Usual Name:	Interbody fusion device
Classification Name:	Intervertebral body fusion device(21 CFR 888.3080)
Regulatory Class:	Class II
Product Code:	PHM, MAX

III. LEGALLY MARKETED PREDICATE AND REFERENCE DEVICES

510(k)	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K160958	PHM, MAX	Battalion Universal Spacer System	Alphatec Spine
Additional Predicate Devices
K080699	MQP, MAX	Novel Spinal Spacer System	Alphatec Spine
K171633	PHM, MAX	NuVasive® TLX Interbody System	NuVasive, Inc.
Reference Devices
K161485	MAX, ODP	Forticore System	Nanovis, LLC.
K151256	PLF, HRS, HWC	Arthrex BioSync® Bone Wedge	Arthrex, Inc.

IV. DEVICE DESCRIPTION

ATEC Universal Spacer System includes the Battalion Universal Spacer System and Porous Ti Spacer System.

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V. INDICATIONS FOR USE

The ATEC Universal Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.

TECHNOLOGICAL COMPARISON TO PREDICATES VI.

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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PERFORMANCE DATA VII.

The following non-clinical tests support the substantial equivalence determination as discussed in Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.

Performance data and engineering analysis demonstrate that the subject ATEC Universal Spacer System is substantially equivalent to the predicates. Testing and analysis include the following:

Static Compression (per ASTM F2077) ●
Dynamic Compression (per ASTM F2077) ●
Static Compression Shear (per ASTM F2077) ●
Dynamic Compression Shear (per ASTM F2077)
. Gravimetric and Particulate analysis (ASTM F1714 and F1877)
Push-out (per ASTM F04-25-02-02 Draft)
. Subsidence (per ASTM F2267)
Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016 ●

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 regards 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.