The Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-O, Aries®-A, and Aries®-L) are interbody fusion devices intended for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The Aries® Lumbar Interbodies are interbody fusion devices used to provide structural stability in skeletally mature patients. The implants were developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). 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. Each interbody has an axial hole to allow grafting material to be placed inside of the interbody. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

AI/ML Overview

This document describes Aries® Lumbar Interbodies, an intervertebral body fusion device, and its acceptance criteria for FDA clearance.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Static & Dynamic Compression (per ASTM F2077)	Met recommended performance, equivalent to predicate devices.
Static & Dynamic Torsion (per ASTM F2077)	Met recommended performance, equivalent to predicate devices.
Static & Dynamic Compression-Shear (per ASTM F2077)	Met recommended performance, equivalent to predicate devices.
Subsidence (per ASTM F2267)	Met recommended performance, equivalent to predicate devices.
Pyrogenicity (LAL assay)	Meets recommended maximum endotoxin level of 20 EU per device.
Material (Ti-6Al-4V per ASTM F3001)	Device fabricated from the same material as predicate devices.
Design Features/Functions	Similar basic design features and functions as predicate devices.
Dimensions	Dimensionally similar to cited predicate devices.
Sterilization	Provided sterile, similar to predicate devices (sterile for single use only).
Intended Use	Similar intended uses as predicate devices.
Mechanical Safety and Performance	Equivalent performance to the cited predicate device under the same test conditions.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not include information on sample size for a test set or data provenance for any clinical studies. It explicitly states, "No clinical studies were performed." The testing conducted was non-clinical (mechanical and pyrogenicity).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable as no clinical studies were performed, and thus no expert-established ground truth for a test set was required in this submission. The "ground truth" for the non-clinical tests was established through adherence to recognized ASTM standards.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical studies requiring human adjudication were performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical studies were performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is an intervertebral body fusion device, which is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was based on established industry standards and specifications (ASTM F2077, ASTM F2267, ASTM F3001, and pyrogenicity limits). The goal was to demonstrate equivalence to predicate devices, meaning the device performed within the acceptable parameters defined by these standards, similar to already cleared devices.

8. The Sample Size for the Training Set

This information is not applicable as there was no algorithm or AI component requiring a training set. The device is a physical medical implant.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there was no algorithm or AI component requiring a training set or its associated ground truth.

Summary

{0}------------------------------------------------

Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Osseus Fusion Systems, LLC % J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681

Re: K181347

Trade/Device Name: Aries® Lumbar Interbodies Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 18, 2018 Received: July 20, 2018

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 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

August 15, 2018

{1}------------------------------------------------

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 (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent Showalter -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K181347

Device Name

Aries® Lumbar Interbodies

Indications for Use (Describe)

The Aries® Lumbar Interbodies (Aries®-TC, Aries®-TC, Aries®-A, and Aries®-L) are interbody fusion devices intended for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary: Aries® Lumbar Interbodies

Date Prepared	July 18, 2018
Submitted By	Osseus Fusion Systems, LLC2703 W. Mockingbird Ln., Ste. #102Dallas, TX 75204(888) 330-5960 Tele
Primary Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telejdwebb@orthomedix.net
Trade Name	Aries® Lumbar Interbodies
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	• EIT Cellular Titanium® TLIF Cages, EIT Emerging Implant Technologies, GmbH(K170503)
SecondaryPredicate Devices	• CASCADIA™ Interbody System, K2M, Incorporated (K160547/K162264/ K172009/K172941)• BAK/L Interbody Fusion System, Zimmer (P950002)• Oracle Cage System, Synthes (K072791)• ALEUTIAN® Anatomically-Narrow Oblique Interbody System, K2M, Incorporated(K082698/ K101302)
Reference PredicateDevices	• Ray Threaded Lumbar Fusion Cage, Stryker (P950019)• Brantigan I/F Cage, DePuy Spine, Inc (P960025)• Talos Intervertebral Body Fusion Devices, Meditech Spine, LLC (K090707/ K150788)• LDR Spine Cervical Interbody Fusion System, LDR Spine (K091088)
Device Description	The Aries® Lumbar Interbodies are interbody fusion devices used to provide structuralstability in skeletally mature patients. The implants were developed for the substitution ofthe classical autogenous bone graft blocks. The cages assist to avoid complicationsrelated to the bone graft donation site (chronic pain, hematoma, infection, bone removalfrom the donor site making it impossible to remove bone again, quality of the iliac bone,accessing a healthy donor site that may become an unhealthy site, hernias by theincision). The system is comprised of interbodies of various fixed heights and footprintsto fit the anatomical needs of a wide variety of patients and multiple surgical approaches.Each interbody has an axial hole to allow grafting material to be placed inside of theinterbody. Protrusions on the superior and inferior surfaces of each device grip theendplates of the adjacent vertebrae to resist expulsion.
Materials	3D-printed titanium (Ti-6Al-4V) per ASTM F3001
Intended Use	The Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-O, Aries®-A, and Aries®-L) are used to maintain disc space distraction and structural stability until fusion occurs inskeletally mature adults requiring lumbar interbody fusion.
SubstantialEquivalence Claimedto Predicate Devices	The Aries® Lumbar Interbodies is substantially equivalent to the predicate devices interms of intended use, design, materials used, mechanical safety and performances.
Indications for Use	The Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-O, Aries®-A, and Aries®-L) are interbody fusion devices intended for intervertebral body fusion procedures inskeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at oneor two contiguous levels from L2 to S1. DDD is defined as discogenic pain withdegeneration of the disc confirmed by history and radiographic studies. These DDDpatients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involvedlevel(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/orallograft comprised of cancellous and/or corticocancellous bone graft and supplementalfixation. Patients should have at least six (6) months of non-operative treatment prior totreatment with an intervertebral cage.
Summary of thetechnologicalcharacteristicscompared to predicate	Intended UseThe Aries® Lumbar Interbodies and all the predicates have similar intended uses.MaterialsThe Aries® Lumbar Interbodies is fabricated from the same material as the predicatedeviceDesign Features/FunctionsThe Aries® Lumbar Interbodies and cited predicate devices share similar basic designfeatures and functions.DimensionsThe Aries® Lumbar Interbodies is dimensionally similar to cited predicate devices.SterilizationThe Aries® Lumbar Interbodies is provided sterile and cited predicate devices are sterilefor single use only.Performance SpecificationMechanical testing confirmed the Aries® Lumbar Interbodies demonstrated equivalentperformance to the cited predicate device under the same test conditions.
Non-clinical TestSummary	The following analyses were conducted:> Static and Dynamic Compression per ASTM F2077> Static and Dynamic Torsion per ASTM F2077> Static and Dynamic Compression-Shear per ASTM F2077> Subsidence per ASTM F2267> Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay.The testing demonstrated that the subject device meets the recommendedmaximum endotoxin level of 20 EU per device.The results of these evaluations indicate that the Aries® Lumbar Interbodies are equivalentto predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Osseus Fusion Systems considers the Aries® Lumbar Interbodies to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices' similarities inprinciples of operation, technology, materials and indications for use

{4}------------------------------------------------

{5}------------------------------------------------

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.