MODULIF-A Anterior Lumbar Interbody Fusion System by Spinal Stability, LLC

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.

Device Description

The Spinal Stability MODULIF-A is a modular interbody fusion cage intended for the treatment of degenerative disc disease in the lumbar spine used to provide structural stability in skeletally mature patients. The MODULIF-A device is composed of two endplates and a central spacer. The device may be implanted as a single construct via an anterior approach. The system is comprised of interbodies of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients and multiple surgical approaches.

AI/ML Overview

The provided document is a 510(k) summary for the MODULIF-A Anterior Lumbar Interbody Fusion System. It states that no clinical studies were performed for this device. Therefore, the device's acceptance criteria and the study proving it meets them are established through non-clinical testing and comparison to predicate devices, rather than human clinical trials.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Static and Dynamic Compression per ASTM F2077	Results indicate equivalence to predicate devices.
Static Torsion per ASTM F2077	Results indicate equivalence to predicate devices.
Static and Dynamic Compression-Shear per ASTM F2077	Results indicate equivalence to predicate devices.
Subsidence per ASTM F2267	Results indicate equivalence to predicate devices.
Expulsion	Results indicate equivalence to predicate devices.
Sterility validation per ISO 17665-1: 2006	Validated per standard.
Cleaning validation per AAMI TIR30	Validated per standard.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for the mechanical and material tests conducted according to ASTM and ISO standards. The data provenance is from non-clinical bench testing rather than human subjects or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for the non-clinical tests is established by the specifications and requirements of the referenced ASTM and ISO standards, which are developed through a consensus process by experts in the relevant fields (e.g., materials science, biomechanics, sterilization). The document does not specify the individual experts involved in establishing these standards or the internal testing protocols.

4. Adjudication method for the test set

Not applicable. This concept typically applies to clinical studies where expert consensus is needed to determine outcomes or ground truth on patient data. For non-clinical bench testing, the results are objectively measured against the specified criteria of the test standards.

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

No. The document explicitly states: "No clinical studies were performed." This device is not an AI-assisted diagnostic tool, but rather an implanted medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an implanted medical device, not a standalone algorithm. Performance is assessed through non-clinical mechanical and material testing.

7. The type of ground truth used

The ground truth used for the device's performance evaluation is established by internationally recognized engineering and material standards (e.g., ASTM F2077, ASTM F2267, ISO 17665-1, AAMI TIR30). Compliance with these standards serves as the ground truth for the mechanical strength, durability, and biocompatibility of the device.

8. The sample size for the training set

Not applicable. This device is an implanted medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

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Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

Date Prepared	July 13, 2020
Submitted By	Spinal Stability, LLC104 Hensley CircleAustin, Texas 78738 USA512-633-5313
Primary Contact	J.D. Webb4313 W. 3800 SWest Haven, UT 84401512-590-5810 Telee-mail: jdwebb@orthomedix.net
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 PredicateDevice	InFix® Anterior Lumbar System, Zimmer Spine, (K132790)
Additional PredicateDevices	A-Wedge Anterior Interbody System, SpineWorks (K111166)Mojave Expandable Interbody System, K2M (K163364)Pathway ELIF, Custom Spine, Inc. (K143143)
Device Description	The Spinal Stability MODULIF-A is a modular interbody fusion cage intended for thetreatment of degenerative disc disease in the lumbar spine used to provide structuralstability in skeletally mature patients. The MODULIF-A device is composed of twoendplates and a central spacer. The device may be implanted as a single construct viaan anterior approach. The system is comprised of interbodies of various fixed heightsand footprints to fit the anatomical needs of a wide variety of patients and multiplesurgical approaches.
Materials	• Ti-6Al-4V Grade 23 per ASTM F136• Ti-6Al-4V Grade 5 per ASTM F1472• CP Titanium per ASTM F1580• 316 L SST per ASTM A580
Intended Use	MODULIF-A is used to maintain disc space distraction and structural stability until fusionoccurs in skeletally mature adults requiring lumbar interbody fusion.
SubstantialEquivalence Claimedto Predicate Devices	The MODULIF-A is substantially equivalent to the predicate devices in terms of intendeduse, design, materials used, mechanical safety and performances.
Indications for Use	MODULIF-A is an interbody fusion device intended for spinal fusion procedures at one ortwo 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 discconfirmed by history and radiographic studies. DDD patients may have up to Grade Ispondylolisthesis or retrolisthesis at the involved levels. These patients may have had aprevious non-fusion spinal procedure at the involved level(s).The device system is designed for use with supplemental fixation and with autogenous orallograft bone graft comprised of cancellous and / or corticocancellous bone graft tofacilitate fusion. Patients should have six months of non-operative treatment prior totreatment with an interbody fusion cage. Patients with previous non-fusion spinal surgeryat 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 maintainadequate disc space until fusion occurs.
Indications for Use	All of the devices comply with the indications for use specified in 21 CFR section 888.3080for cervical interbody fusion devices
Summary of thetechnologicalcharacteristicscompared topredicate	MaterialThe MODULIF-A uses the same material as the predicate device.DesignThe MODULIF-A and the predicate are equivalent in terms of shape, material, andmanufacturing process.SizesThe MODULIF-A and the predicates are equivalent in their dimensions.StrengthThe MODULIF-A has greater or equivalent strength values compared to other devicescleared for use in the lumbar spine.
Non-clinical TestSummary	The following analyses were conducted:> Static and Dynamic Compression per ASTM F2077> Static Torsion per ASTM F2077> Static and Dynamic Compression-Shear per ASTM F2077> Subsidence per ASTM F2267> Expulsion> Sterility validation per ISO 17665-1: 2006> Cleaning validation per AAMI TIR30The results of these evaluations indicate that the MODULIF-A Anterior Lumbar InterbodyFusion System is equivalent to predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Spinal Stability considers the MODULIF-A to be equivalent to the predicate devices listedabove. This conclusion is based upon the devices' similarities in principles of operation,technology, materials and indications for use

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

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Regulation Number and Section

N/A