Mobarn 80:20 Lumbar Interbody Fusion System is intended for spinal fusion procedures to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had previous non-fusion spinal surgery at the involved spinal level(s) and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Mobarn 80:20 Lumbar Interbody Fusion System is to be combined with supplemental fixation.

Device Description

The Mobarn 80:20 Lumbar Interbody Fusion System consists of a family of additively manufactured titanium (Ti6Al4V-ELI) lumbar intervertebral body fusion devices (LIBF) designed to facilitate lumbar spinal fusion through various surgical approaches, as listed below.

Posterior Lumbar Interbody Fusion (PLIF)
Transforaminal Lumbar Interbody Fusion (TLIF)
Direct Lateral Lumbar Interbody Fusion (DLIF)
Anterior Lumbar Interbody Fusion (ALIF)

The Mobarn 80:20 Lumbar Interbody Fusion System is intended for use in lumbar intervertebral fusion procedures. These devices are designed to provide structural support and stabilization to facilitate bony fusion in patients with degenerative disc disease (DDD) and other conditions requiring interbody fusion.

The design of the implants consists of an open architecture surrounded by a titanium frame to accommodate autograft and/or allogenic bone graft, comprised of cancellous and/or cortico-cancellous bone graft. Each implant is engineered with an 80% open area to accommodate autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft, maximizing bone graft contact and fusion potential, while maintaining mechanical integrity through a titanium frame that makes up the remaining 20% and offers structural support. The implants are available in a variety of footprints, heights, and lordotic angles to approximate anatomical variation in different vertebral levels and/or patient anatomy.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - Mobarn 80:20 Lumbar Interbody Fusion System

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

September 18, 2025

Mobarn Medical Devices, LLC
℅ Lisa Ferrara, Ph.D.
Consultant - Regulatory and Technical
Hypoid Ventures, LLC
640 Grand Oaks Drive
Hendersonville, North Carolina 28792

Re: K251479

Trade/Device Name: Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))

Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX
Dated: August 18, 2025
Received: August 20, 2025

Dear Dr. Ferrara:

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 (the 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 available 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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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-devices/device-advice-comprehensive-regulatory-assistance/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 -S

Brent Showalter, Ph.D.
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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Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.

K251479

Please provide the device trade name(s).

Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF));
Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF));
Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF));
Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))

Please provide your Indications for Use below.

Please select the types of uses (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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Traditional 510(k) Premarket Notification

Mobarn Medical Devices, LLC - Lumbar Interbody Fusion System

510(k) Statement – Summary of Safety and Effectiveness

A 510(k) Summary of the safety and effectiveness information upon which this substantial equivalence determination is based, is provided in this section.

Field	Information
Submitter	Mobarn Medical Devices, LLC
Address	900 Camp St Ste 449New Orleans, LA 70130
Telephone	504-460-7305
Contact Person	Richard Ehret, Managing Member
Address	900 Camp St Ste 449, New Orleans, LA 70130
Telephone	504-460-7305
Email	richard.b.ehret@gmail.com
Date Prepared	April 25, 2025
Trade Name	Mobarn 80:20 Lumbar Interbody Fusion System
510k Review Panel	Orthopedic
Classification Name	Intervertebral Fusion Device with Bone Graft, Lumbar
Regulation Number	21 CFR 888.3080
Regulatory Class	II
Product Code	MAX

Predicate Device (Primary)	510 (k) Number	Manufacturer
Zyston Strut Open Titanium Spacer System	K171495	Zimmer Biomet Spine Inc.

Reference Device (Additional)	510 (k) Number	Manufacturer
4Web Medical PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)	K143258	4Web Medical Inc.

K251479
Page 1 of 3

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Description of Device

Posterior Lumbar Interbody Fusion (PLIF)
Transforaminal Lumbar Interbody Fusion (TLIF)
Direct Lateral Lumbar Interbody Fusion (DLIF)
Anterior Lumbar Interbody Fusion (ALIF)

Indications and Intended Use

K251479
Page 2 of 3

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Technological Characteristics Substantial Equivalence

Summary of Technological Characteristics

The Mobarn 80:20 Lumbar Interbody Fusion System (Subject device) has the following similarities listed below to the primary and reference predicates which have received 510(k) clearance;

same indicated use and indications for use,
same operating principle,
incorporates similar open architecture geometrical designs, and sizes,
incorporates similar materials – Ti6Al4V
additively manufactured devices which have a similar manufacturing process as the predicate
comparable instruments of similar material to the predicate
similar mechanical performance (per mechanical testing via ASTM F2077 & ASTM F2267)
similar Biocompatibility Properties

Based on the design, intended use, and performance characteristics, the Mobarn 80:20 Lumbar Interbody Fusion System is expected to perform as safely and effectively as its predicate devices.

Performance

Mechanical testing was conducted per FDA's Guidance for Industry and FDA Staff – Spinal System 510(k)s dated May 3, 2004, and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device dated June 12, 2007.

Performance testing was performed to demonstrate substantial equivalence to the predicate device(s).

Performance testing included;

ASTM F2077 (static and dynamic axial compression, static and dynamic compressive shear)
ASTM F2267 (subsidence).
Expulsion

Magnetic Resonance environment

The Mobarn Medical Devices Mobarn 80:20 Lumbar Interbody Fusion System has not been evaluated for safety and compatibility in the Magnetic Resonance environment. They have not been tested for heating or migration in the Magnetic Resonance environment.

Conclusion

Based on the indications for use, technological characteristics, design, materials, and comparison to predicate devices, the Mobarn 80:20 Lumbar Interbody Fusion System is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use.

K251479
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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.