ATEC ALIF and LLIF Spacer System

K182746 · Alphatec Spine, Inc. · MAX · Nov 27, 2018 · Orthopedic

Device Facts

• Record ID: K182746
• Device Name: ATEC ALIF and LLIF Spacer System
• Applicant: Alphatec Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Nov 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ATEC ALIF and LLIF 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. 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 ALIF and LLIF 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 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. ATEC LLIF interbody implants with >20° lordosis must be used with the ATEC LLIF AMP integrated fixation in addition to supplemental fixation. ATEC ALIF interbody implants with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.

Device Story

Intervertebral body fusion system; implants (ALIF/LLIF) inserted via anterior, anterolateral, or lateral approaches; internal graft aperture for bone graft placement; surface teeth for migration resistance; porous geometry for fixation. Includes LLIF AMP integrated fixation (plates, screws). Used in surgical settings by surgeons to treat spinal degeneration; provides structural support to facilitate fusion; benefits patients by stabilizing spinal segments and reducing pain associated with discogenic disease.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including dynamic axial compression, dynamic compression-shear, subsidence analysis, push-out testing, particulate/gravimetric analysis, and bacterial endotoxin testing.

Technological Characteristics

Materials: PEEK Optima LT1 (ASTM F2026), titanium coating (ASTM F1580), tantalum (ASTM F560), Ti-6Al-4V ELI (ASTM F136), CPTi Grade 2 (ASTM F67). Features: porous geometry, internal graft aperture, surface teeth. Integrated fixation: titanium alloy plates/screws. Mechanical fixation via supplemental systems.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion at one or two contiguous levels in the thoracolumbar spine (T1-L1 thoracic; L1-S1 lumbar). Treats symptomatic degenerative disc disease (DDD), including thoracic disc herniation and lumbar DDD with up to Grade I spondylolisthesis or retrolisthesis. 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

• ATEC Universal Spacer System (K180480)
• ATEC ALIF Spacer System (K181453)
• Battalion Universal Spacer System (K160958)
• Novel ALIF Spinal Spacer System (K090782)
• Battalion Universal Spacer System (K143740)
• Anterior Lumbar Plating System (K101255)
• Zimmer Biomet Fusion System (K163543)
• XLX Interbody System (K173892)
• Zou® Anterior Lumber Plate System (K121791)
• Solus Anterior Lumbar Interbody Fusion System (K102402)

Submission Summary (Full Text)

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November 27, 2018

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

Re: K182746

Trade/Device Name: ATEC ALIF and LLIF Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, PHM, OVD Dated: September 27, 2018 Received: September 28, 2018

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 mav, 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 avare 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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

Sincerely.

Katherine D. Kavlock -S

for 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) K182746

Device Name ATEC ALIF and LLIF Spacer System

### Indications for Use (Describe)

The ATEC ALIF and LLIF 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.

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 ALIF and LLIF 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 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.

ATEC LLIF interbody implants with >20° lordosis must be used with the ATEC LLIF AMP integrated fixation in addition to supplemental fixation. ATEC ALIF interbody implants with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.

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

| | <span style="text-decoration:overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--|-----------------------------------------------------------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510k Summary ATEC ALIF and LLIF Spacer System K182747

| I. | SUBMITTER: | 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: September 27, 2018

#### II. DEVICE

| Name of Device: | ATEC ALIF and LLIF Spacer System |
|-----------------------|------------------------------------------------------|
| Common or Usual Name: | Intervertebral fusion device with bone graft, lumbar |
| Classification Name: | Intervertebral body fusion device |
| | (21 CFR 888.3080) |
| Regulatory Class: | Class II |
| Product Code: | MAX, PHM, OVD |

#### III. LEGALLY MARKETED PREDICATE DEVICES

| 510(k) | Product Code | Trade Name | Manufacturer |
|-------------------------------------|---------------|--------------------------------------------------|----------------|
| <b>Primary Predicate Device</b> | | | |
| K180480 | PHM, MAX | ATEC Universal Spacer System | Alphatec Spine |
| <b>Additional Predicate Devices</b> | | | |
| K181453 | PHM, MAX | ATEC ALIF Spacer System | Alphatec Spine |
| K160958 | PHM, MAX | Battalion Universal Spacer System | Alphatec Spine |
| K090782 | MAX | Novel ALIF Spinal Spacer System | Alphatec Spine |
| K143740 | MAX | Battalion Universal Spacer System | Alphatec Spine |
| K101255 | KWQ | Anterior Lumbar Plating System | Alphatec Spine |
| K163543 | MAX, OVD | Zimmer Biomet Fusion System | Zimmer Biomet |
| K173892 | MAX, PHM, OVD | XLX Interbody System | NuVasive Inc. |
| K121791 | KWQ | Zou® Anterior Lumber Plate<br>System | CoreLink LLC |
| K102402 | OVD | Solus Anterior Lumbar Interbody<br>Fusion System | Alphatec Spine |

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#### IV. DEVICE DESCRIPTION

The ATEC ALIF and LLIF Spacer System is an intervertebral body fusion system. The ATEC ALIF and LLIF Spacer System includes interbody implants marketed as Battalion Universal Spacer System and IdentiTi Porous Ti Spacer System, implanted from an anterior, anterolateral and lateral approach. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured from 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 graft material to promote fusion through the cage.

The ATEC ALIF and LLIF Spacer System also includes LLIF AMP integrated fixation to be used with the LLIF interbody offerings. The LLIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136.

#### V. INDICATIONS FOR USE

The ATEC ALIF and LLIF 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 ALIF and LLIF 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 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.

ATEC LLIF interbody implants with >20° lordosis must be used with the ATEC LLIF AMP integrated fixation in addition to supplemental fixation. ATEC ALIF interbody implants with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.

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#### 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.

#### VII. PERFORMANCE DATA

Nonclinical testing performed on the ATEC ALIF and LLIF Spacer 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 testing per ASTM F04-25-02-02 draft ●
- 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 ALIF and LLIF Spacer 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.

#### CONCLUSION VIII.

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.