MODULIF-A Anterior Lumbar Interbody Fusion System

K200958 · Spinal Stability, LLC · MAX · Aug 28, 2020 · Orthopedic

Device Facts

• Record ID: K200958
• Device Name: MODULIF-A Anterior Lumbar Interbody Fusion System
• Applicant: Spinal Stability, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Aug 28, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MODULIF-A is used to maintain disc space distraction and structural stability until fusion occurs in skeletally mature adults requiring lumbar interbody fusion. The MODULIF-A and the predicate devices are all intended to be used to maintain adequate disc space until fusion occurs.

Device Story

Modular interbody fusion cage; provides structural stability in lumbar spine. Composed of two endplates and central spacer; implanted via anterior approach. Used in conjunction with supplemental fixation and bone graft (autogenous or allograft) to facilitate fusion. Designed for use in clinical settings by surgeons. Device maintains disc space distraction until fusion occurs. Benefits patient by stabilizing spinal segment in degenerative disc disease cases.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including static and dynamic compression, static torsion, compression-shear, subsidence, and expulsion testing per ASTM standards, alongside sterility and cleaning validation.

Technological Characteristics

Modular interbody fusion cage. Materials: Ti-6Al-4V Grade 23 (ASTM F136), Ti-6Al-4V Grade 5 (ASTM F1472), CP Titanium (ASTM F1580), 316L SST (ASTM A580). Mechanical testing per ASTM F2077 and ASTM F2267. Sterilization via ISO 17665-1:2006. No software or electronic components.

Indications for Use

Indicated for spinal fusion at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD), defined as discogenic back pain with degeneration confirmed by history and radiography. Includes patients with up to Grade I spondylolisthesis or retrolisthesis, or prior non-fusion spinal procedures. Requires six months of prior non-operative treatment. Must be used with supplemental fixation and autogenous or allograft bone graft.

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

• InFix® Anterior Lumbar System, Zimmer Spine (K132790)
• A-Wedge Anterior Interbody System, SpineWorks (K111166)
• Mojave Expandable Interbody System, K2M (K163364)
• Pathway ELIF, Custom Spine, Inc. (K143143)

Submission Summary (Full Text)

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August 28, 2020

Spinal Stability, LLC % J.D. Webb Authorized Contact Person The OrthoMedix Group, Inc 4313 W. 3800 S. West Haven, Utah 84401

Re: K200958

Trade/Device Name: MODULIF-A Anterior Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 28, 2020 Received: July 31, 2020

Dear Mr. Webb:

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

Sincerely.

Brent Showalter, Ph.D. Acting 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: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K200958

Device Name

MODULIF-A Anterior Lumbar Interbody Fusion System

## Indications for Use (Describe)

MODULIF-A is an interbody fusion device intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal procedure at the involved level(s).

The device system is designed for use with supplemental fixation and with autogenous or allograft comprised of cancellous and / or corticocancellous bone graft to facilitate fusion. Patients should have six months of non-operative treatment prior to treatment with an interbody fusion cage. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device.

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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FORM FDA 3881 (7/17)

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## 510(k) Summary: MODULIF-A Anterior Lumbar Interbody Fusion System

| Date Prepared | July 13, 2020 |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Spinal Stability, LLC<br>104 Hensley Circle<br>Austin, Texas 78738 USA<br>512-633-5313 |
| Primary Contact | J.D. Webb<br>4313 W. 3800 S<br>West Haven, UT 84401<br>512-590-5810 Tele<br>e-mail: [e-mail] |
| Trade Name | MODULIF-A Anterior Lumbar Interbody Fusion System |
| Common Name | intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - lumbar |
| Class | II |
| Product Code | MAX |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate<br>Device | InFix® Anterior Lumbar System, Zimmer Spine, (K132790) |
| Additional Predicate<br>Devices | A-Wedge Anterior Interbody System, SpineWorks (K111166)<br>Mojave Expandable Interbody System, K2M (K163364)<br>Pathway ELIF, Custom Spine, Inc. (K143143) |
| Device Description | The Spinal Stability MODULIF-A is a modular interbody fusion cage intended for the<br>treatment of degenerative disc disease in the lumbar spine used to provide structural<br>stability in skeletally mature patients. The MODULIF-A device is composed of two<br>endplates and a central spacer. The device may be implanted as a single construct via<br>an anterior approach. The system is comprised of interbodies of various fixed heights<br>and footprints to fit the anatomical needs of a wide variety of patients and multiple<br>surgical approaches. |
| Materials | • Ti-6Al-4V Grade 23 per ASTM F136<br>• Ti-6Al-4V Grade 5 per ASTM F1472<br>• CP Titanium per ASTM F1580<br>• 316 L SST per ASTM A580 |
| Intended Use | MODULIF-A is used to maintain disc space distraction and structural stability until fusion<br>occurs in skeletally mature adults requiring lumbar interbody fusion. |
| Substantial<br>Equivalence Claimed<br>to Predicate Devices | The MODULIF-A is substantially equivalent to the predicate devices in terms of intended<br>use, design, materials used, mechanical safety and performances. |
| Indications for Use | MODULIF-A is an interbody fusion device intended for spinal fusion procedures at one or<br>two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease<br>(DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies. DDD patients may have up to Grade I<br>spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a<br>previous non-fusion spinal procedure at the involved level(s).<br>The device system is designed for use with supplemental fixation and with autogenous or<br>allograft bone graft comprised of cancellous and / or corticocancellous bone graft to<br>facilitate fusion. Patients should have six months of non-operative treatment prior to<br>treatment with an interbody fusion cage. Patients with previous non-fusion spinal surgery<br>at the involved level may be treated with the device. |
| Intended Use | The MODULIF-A and the predicate devices are all intended to be used to maintain<br>adequate disc space until fusion occurs. |
| Indications for Use | All of the devices comply with the indications for use specified in 21 CFR section 888.3080<br>for cervical interbody fusion devices |
| Summary of the<br>technological<br>characteristics<br>compared to<br>predicate | Material<br>The MODULIF-A uses the same material as the predicate device.<br><br>Design<br>The MODULIF-A and the predicate are equivalent in terms of shape, material, and<br>manufacturing process.<br><br>Sizes<br>The MODULIF-A and the predicates are equivalent in their dimensions.<br><br>Strength<br>The MODULIF-A has greater or equivalent strength values compared to other devices<br>cleared for use in the lumbar spine. |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>> Static and Dynamic Compression per ASTM F2077<br>> Static Torsion per ASTM F2077<br>> Static and Dynamic Compression-Shear per ASTM F2077<br>> Subsidence per ASTM F2267<br>> Expulsion<br>> Sterility validation per ISO 17665-1: 2006<br>> Cleaning validation per AAMI TIR30<br>The results of these evaluations indicate that the MODULIF-A Anterior Lumbar Interbody<br>Fusion System is equivalent to predicate devices. |
| Clinical Test<br>Summary | No clinical studies were performed |
| Conclusions: Non-<br>clinical and Clinical | Spinal Stability considers the MODULIF-A to be equivalent to the predicate devices listed<br>above. This conclusion is based upon the devices' similarities in principles of operation,<br>technology, materials and indications for use |

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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