Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical interbody fusion device and its intended use and testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.

Therapeutic

No.
The device is an interbody fusion device intended to provide structural stability and facilitate fusion in spinal procedures, not to treat a disease or condition itself.

Diagnostic

No
The device is an interbody fusion cage used for structural stability in spinal fusion procedures, not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "modular interbody fusion cage" composed of "two endplates and a central spacer," indicating it is a physical implantable device, not software. The performance studies also describe mechanical testing (compression, torsion, shear, subsidence, expulsion) and sterilization/cleaning validation, which are relevant to hardware devices.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
Device Description: The provided text describes a physical implantable device (an interbody fusion cage) used in spinal surgery to provide structural stability. It is not used to test samples from the body.
Intended Use: The intended use is for spinal fusion procedures to treat degenerative disc disease, which is a surgical intervention, not a diagnostic test.

The information provided clearly indicates this is a surgical implant, not a device for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

MAX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Spinal fusion procedures at one or two contiguous levels (L2-S1) in the lumbar spine

Indicated Patient Age Range

skeletally mature patients / skeletally mature adults

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Test Summary: 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 TIR30. The results of these evaluations indicate that the MODULIF-A Anterior Lumbar Interbody Fusion System is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K132790, K111166, K163364, K143143

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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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
104 Hensley Circle
Austin, Texas 78738 USA
512-633-5313
Primary Contact	J.D. Webb
4313 W. 3800 S
West Haven, UT 84401
512-590-5810 Tele
e-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 Predicate
Device	InFix® Anterior Lumbar System, Zimmer Spine, (K132790)
Additional Predicate
Devices	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 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.
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 fusion
occurs in skeletally mature adults requiring lumbar interbody fusion.
Substantial
Equivalence Claimed
to Predicate Devices	The MODULIF-A is substantially equivalent to the predicate devices in terms of intended
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
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 bone graft 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.
Intended Use	The MODULIF-A and the predicate devices are all intended to be used to maintain
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
for cervical interbody fusion devices
Summary of the
technological
characteristics
compared to
predicate	Material
The MODULIF-A uses the same material as the predicate device.

Design
The MODULIF-A and the predicate are equivalent in terms of shape, material, and
manufacturing process.

Sizes
The MODULIF-A and the predicates are equivalent in their dimensions.

Strength
The MODULIF-A has greater or equivalent strength values compared to other devices
cleared for use in the lumbar spine. |
| Non-clinical Test
Summary | 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 TIR30
The results of these evaluations indicate that the MODULIF-A Anterior Lumbar Interbody
Fusion System is equivalent to predicate devices. |
| Clinical Test
Summary | No clinical studies were performed |
| Conclusions: Non-
clinical and Clinical | Spinal Stability considers the MODULIF-A to be equivalent to the predicate devices listed
above. 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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