Aries® Lumbar Interbodies

K181347 · Osseus Fusion Systems, LLC · MAX · Aug 15, 2018 · Orthopedic

Device Facts

• Record ID: K181347
• Device Name: Aries® Lumbar Interbodies
• Applicant: Osseus Fusion Systems, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Aug 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

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 in skeletally mature adults requiring lumbar interbody fusion.

Device Story

Aries® Lumbar Interbodies are 3D-printed titanium intervertebral fusion cages designed to provide structural stability and maintain disc space distraction. The device features an axial hole for bone graft material and surface protrusions to grip vertebral endplates and resist expulsion. Used in lumbar spine fusion procedures (L2-S1) for patients with degenerative disc disease. The device is implanted by a surgeon to replace autogenous bone graft blocks, reducing donor site complications. It is intended for use with supplemental fixation. Clinical benefit includes stabilization of the spinal segment to facilitate fusion.

Clinical Evidence

No clinical data. Bench testing only: static/dynamic compression, torsion, and compression-shear (ASTM F2077); subsidence (ASTM F2267); and pyrogenicity (LAL assay) confirming endotoxin levels < 20 EU/device.

Technological Characteristics

3D-printed titanium (Ti-6Al-4V) per ASTM F3001. Interbody cage form factor with axial graft hole and surface protrusions. Sterile, single-use. Mechanical testing per ASTM F2077 and F2267.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD defined as discogenic pain with degeneration confirmed by history/radiographic studies. May include up to Grade 1 spondylolisthesis or retrolisthesis. Use with autogenous bone graft and/or allograft (cancellous/corticocancellous) and supplemental fixation. Requires at least 6 months of prior non-operative treatment.

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

• EIT Cellular Titanium® TLIF Cages, EIT Emerging Implant Technologies, GmbH (K170503)
• 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 Devices

• 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)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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) | |
|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### 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 [e-mail]

"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, LLC<br>2703 W. Mockingbird Ln., Ste. #102<br>Dallas, TX 75204<br>[phone] Tele |
| Primary Contact | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>[e-mail] |
| 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 Predicate<br>Device | • EIT Cellular Titanium® TLIF Cages, EIT Emerging Implant Technologies, GmbH<br>(K170503) |
| Secondary<br>Predicate Devices | • CASCADIA™ Interbody System, K2M, Incorporated (K160547/K162264/ K172009/<br>K172941)<br>• BAK/L Interbody Fusion System, Zimmer (P950002)<br>• Oracle Cage System, Synthes (K072791)<br>• ALEUTIAN® Anatomically-Narrow Oblique Interbody System, K2M, Incorporated<br>(K082698/ K101302) |
| Reference Predicate<br>Devices | • Ray Threaded Lumbar Fusion Cage, Stryker (P950019)<br>• Brantigan I/F Cage, DePuy Spine, Inc (P960025)<br>• Talos Intervertebral Body Fusion Devices, Meditech Spine, LLC (K090707/ K150788)<br>• LDR Spine Cervical Interbody Fusion System, LDR Spine (K091088) |
| Device Description | The Aries® Lumbar Interbodies are interbody fusion devices used to provide structural<br>stability in skeletally mature patients. The implants were developed for the substitution of<br>the classical autogenous bone graft blocks. The cages assist to avoid complications<br>related to the bone graft donation site (chronic pain, hematoma, infection, bone removal<br>from the donor site making it impossible to remove bone again, quality of the iliac bone,<br>accessing a healthy donor site that may become an unhealthy site, hernias by the<br>incision). The system is comprised of interbodies of various fixed heights and footprints<br>to fit the anatomical needs of a wide variety of patients and multiple surgical approaches.<br>Each interbody has an axial hole to allow grafting material to be placed inside of the<br>interbody. Protrusions on the superior and inferior surfaces of each device grip the<br>endplates 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®-<br>L) are used to maintain disc space distraction and structural stability until fusion occurs in<br>skeletally mature adults requiring lumbar interbody fusion. |
| Substantial<br>Equivalence Claimed<br>to Predicate Devices | The Aries® Lumbar Interbodies is substantially equivalent to the predicate devices in<br>terms 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®-<br>L) are interbody fusion devices intended for intervertebral body fusion procedures in<br>skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one<br>or two contiguous levels from L2 to S1. DDD is defined as discogenic pain with<br>degeneration of the disc confirmed by history and radiographic studies. These DDD<br>patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved<br>level(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/or<br>allograft comprised of cancellous and/or corticocancellous bone graft and supplemental<br>fixation. Patients should have at least six (6) months of non-operative treatment prior to<br>treatment with an intervertebral cage. |
| Summary of the<br>technological<br>characteristics<br>compared to predicate | Intended Use<br>The Aries® Lumbar Interbodies and all the predicates have similar intended uses.<br>Materials<br>The Aries® Lumbar Interbodies is fabricated from the same material as the predicate<br>device<br>Design Features/Functions<br>The Aries® Lumbar Interbodies and cited predicate devices share similar basic design<br>features and functions.<br>Dimensions<br>The Aries® Lumbar Interbodies is dimensionally similar to cited predicate devices.<br>Sterilization<br>The Aries® Lumbar Interbodies is provided sterile and cited predicate devices are sterile<br>for single use only.<br>Performance Specification<br>Mechanical testing confirmed the Aries® Lumbar Interbodies demonstrated equivalent<br>performance to the cited predicate device under the same test conditions. |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>> Static and Dynamic Compression per ASTM F2077<br>> Static and Dynamic Torsion per ASTM F2077<br>> Static and Dynamic Compression-Shear per ASTM F2077<br>> Subsidence per ASTM F2267<br>> Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay.<br>The testing demonstrated that the subject device meets the recommended<br>maximum endotoxin level of 20 EU per device.<br>The results of these evaluations indicate that the Aries® Lumbar Interbodies are equivalent<br>to predicate devices. |
| Clinical Test<br>Summary | No clinical studies were performed |
| Conclusions: Non-<br>clinical and Clinical | Osseus Fusion Systems considers the Aries® Lumbar Interbodies to be equivalent to the<br>predicate devices listed above. This conclusion is based upon the devices' similarities in<br>principles of operation, technology, materials and indications for use |

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

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