ATEC Lateral Interbody System

K191311 · Alphatec Spine, Inc. · MAX · Aug 12, 2019 · Orthopedic

Device Facts

• Record ID: K191311
• Device Name: ATEC Lateral Interbody System
• Applicant: Alphatec Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Aug 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ATEC Lateral 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 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 Lateral 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. LIF Anti-Migration Plate (AMP) may be used with ATEC Lateral Interbody spacers to provide integrated fixation. Spacers with >20° lordosis must be used with LIF AMP integrated fixation to supplemental fixation.

Device Story

Intervertebral body fusion system; implanted via anterolateral or lateral approach; used in thoracolumbar spine. System includes spacers (PEEK, titanium-coated PEEK, or porous titanium) and LIF Anti-Migration Plate (AMP) integrated fixation. Spacers feature internal graft aperture for bone graft; surface teeth for migration resistance. AMP system includes plates, center locking screws, and bone screws. Used by surgeons in clinical settings to stabilize spinal segments and promote fusion in patients with degenerative disc disease. Spacers with >20° lordosis require AMP fixation. Provides structural support and integrated fixation to supplement cleared supplemental fixation systems.

Clinical Evidence

No clinical data. Substantial equivalence is based on nonclinical bench testing, including dynamic axial compression and compression-shear (ASTM F2077), subsidence analysis, push-out analysis, particulate/gravimetric analysis (ASTM F1877/F1714), and bacterial endotoxin testing (ANSI/AAMI ST72).

Technological Characteristics

Materials: PEEK (ASTM F2026), titanium coating (ASTM F1580), tantalum (ASTM F560), titanium alloy (ASTM F136), and CPTi Grade 2 (ASTM F67). Features porous geometry, internal graft aperture, and surface teeth. Integrated fixation (AMP) uses titanium alloy. Mechanical fixation principle. No software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion at one or two contiguous levels in the thoracolumbar spine (T1-T2 to L5-S1). Treats symptomatic degenerative disc disease (DDD), including thoracic disc herniation and lumbar spondylolisthesis/retrolisthesis (up to Grade I). Requires at least six months of failed non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• IdentiTi Porous Ti Interbody System (K183705)
• ATEC ALIF and LLIF Spacer System (K182746)
• XLX Interbody System (K173892)

Submission Summary (Full Text)

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August 12, 2019

Alphatec Spine, Inc. Cynthia Adams Project Manager, Regulatory Affairs 5818 El Camino Real Carlsbad, California 92008

Re: K191311

Trade/Device Name: ATEC Lateral Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM, OVD Dated: July 16, 2019 Received: July 17, 2019

Dear Ms. Adams:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191311

Device Name ATEC Lateral Interbody System

### Indications for Use (Describe)

The ATEC Lateral 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 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 Lateral 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.

LIF Anti-Migration Plate (AMP) may be used with ATEC Lateral Interbody spacers to provide integrated fixation. Spacers with >20° lordosis must be used with LIF AMP integrated fixation to supplemental fixation.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="line-height: normal;"> <span style="orphans: auto;"> <span style="text-align: start;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: auto;"> <span style="word-spacing: 0px;"> <span style="-webkit-text-stroke-width: 0px;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> | <input type="checkbox"/> 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 consists of a green square with a white "a" inside of it, followed by the word "tec" in white. The background of the logo is a dark blue color.

| <b>I. SUBMITTER:</b> | Alphatec Spine, Inc.<br>5818 El Camino Real<br>Carlsbad, CA 92008<br>Phone: [phone]<br>Fax: [phone] |
|------------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cynthia Adams<br>Project Manager, Regulatory Affairs<br>Contact Phone: [phone] |
| Date Summary Prepared: | May 14, 2019 |
| <b>II. DEVICE</b> | |
| Name of Device: | ATEC Lateral Interbody System |
| Common or Usual Name: | Intervertebral fusion device with bone graft, lumbar<br>Intervertebral fusion device with integrated fixation lumbar |
| Classification Name: | Intervertebral body fusion device<br>(21 CFR 888.3080) |
| Regulatory Class: | Class II |
| Product Code: | MAX, PHM, OVD |

#### LEGALLY MARKETED PREDICATE DEVICES III.

| 510(k) | Product Code | Trade Name | Manufacturer |
|------------------------------|--------------------|-------------------------------------|----------------|
| Primary Predicate Device | | | |
| K183705 | PHM, MAX, OVD, ODP | IdentiTi Porous Ti Interbody System | Alphatec Spine |
| Additional Predicate Devices | | | |
| K182746 | PHM, MAX, OVD | ATEC ALIF and LLIF Spacer System | Alphatec Spine |
| K173892 | MAX, OVD | XLX Interbody System | NuVasive, Inc |

#### IV. DEVICE DESCRIPTION

The ATEC Lateral Interbody System includes IdentiTi LIF Porous Ti Interbody, Battalion LLIF Spacer System and LIF Interbody System. Any of the three subsystems may be used with LIF AMP integrated fixation. The ATEC Lateral Interbody System is an intervertebral body fusion system implanted from an anterolateral or lateral approach. The interbody

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Image /page/4/Picture/1 description: The image shows the logo for Atec. The logo consists of a green square with a white curved line inside, followed by the word "atec" in white. The letters are lowercase, and there is a trademark symbol after the "c". The background is a dark blue color.

implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, titanium coating per ASTM F1580, tantalum per ASTM F560, titanium alloy (Ti- 6Al-4V ELI) per ASTM F136, and commercially pure titanium (CPTi Grade 2) per ASTM F67. 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 commercially pure titanium implants are 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 interbody implants feature an internal graft aperture for placement of bone graft to promote fusion through the cage.

The ATEC Lateral Interbody System includes LIF Anti-Migration Plate (AMP) integrated fixation that may be used with all ATEC Lateral Interbody offerings. The LIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136. This 510(k) submission seeks clearance to add size options to the LIF AMP portfolio.

#### INDICATIONS FOR USE V.

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

Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). 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 Lateral 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.

LIF Anti-Migration Plate (AMP) may be used with ATEC Lateral Interbody spacers to provide integrated fixation. Spacers with >20° lordosis must be used with LIF AMP integrated fixation in addition to supplemental fixation.

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Image /page/5/Picture/1 description: The image shows the logo for Atec. The logo consists of a green square with a white stylized "a" inside of it. To the right of the square is the word "tec" in white font. There is a trademark symbol to the upper right of the "c".

#### 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.

#### PERFORMANCE DATA VII.

Nonclinical testing performed on the ATEC Lateral Interbody System supports substantial equivalence to other predicate devices. The following testing was performed:

- Dynamic axial compression testing per ASTM F2077
- Dynamic compression-shear testing per ASTM F2077 ●
- . Subsidence analysis
- Push-out analysis
- . Particulate and gravimetric analysis per ASTM F1877 and ASTM F1714
- . Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016

The results demonstrate that the subject ATEC Lateral Interbody System is 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 regards to indications for use, intended use, design, technology, and performance.