Predicate Devices

K170503, K160547, K162264, K172009, K172941, P950002, K072791, K082698, K101302

Reference Devices

P950019, P960025, K090707, K150788, K091088

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and structural stability of the interbody fusion device, with no mention of AI or ML.

Therapeutic

Yes
The device is an interbody fusion device intended for intervertebral body fusion procedures to treat degenerative disc disease and acts as a substitute for autogenous bone graft blocks, aiming to relieve pain and provide structural stability.

Diagnostic

No

This device is an interbody fusion device intended for use in spinal fusion procedures to provide structural stability, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states that the Aries® Lumbar Interbodies are physical implants made of material, designed to provide structural stability and substitute for bone graft blocks. This indicates a hardware device, not software.

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 Aries® Lumbar Interbodies are physical implants designed to be surgically placed in the spine to provide structural support and facilitate bone fusion. They are not used to analyze samples from the body.
Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by fusing vertebrae, not a diagnostic test.

The device is a surgical implant, not a diagnostic tool.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

MAX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lumbar spine at one or two contiguous levels from L2 to S1

Indicated Patient Age Range

skeletally mature patients

Intended User / Care Setting

Prescription Use

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 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 recommended maximum endotoxin level of 20 EU per device. The results of these evaluations indicate that the Aries® Lumbar Interbodies are equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K170503, K160547, K162264, K172009, K172941, P950002, K072791, K082698, K101302

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

P950019, P960025, K090707, K150788, K091088

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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

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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)

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510(k) Summary: Aries® Lumbar Interbodies

Date Prepared	July 18, 2018
Submitted By	Osseus Fusion Systems, LLC
2703 W. Mockingbird Ln., Ste. #102
Dallas, TX 75204
(888) 330-5960 Tele
Primary Contact	J.D. Webb
1001 Oakwood Blvd
Round Rock, TX 78681
512-388-0199 Tele
jdwebb@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 Predicate
Device	• EIT Cellular Titanium® TLIF Cages, EIT Emerging Implant Technologies, GmbH
(K170503)
Secondary
Predicate 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 Predicate
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)
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.
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 in
skeletally mature adults requiring lumbar interbody fusion.
Substantial
Equivalence Claimed
to Predicate Devices	The Aries® Lumbar Interbodies is substantially equivalent to the predicate devices in
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®-
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.
Summary of the
technological
characteristics
compared to predicate	Intended Use
The Aries® Lumbar Interbodies and all the predicates have similar intended uses.
Materials
The Aries® Lumbar Interbodies is fabricated from the same material as the predicate
device
Design Features/Functions
The Aries® Lumbar Interbodies and cited predicate devices share similar basic design
features and functions.
Dimensions
The Aries® Lumbar Interbodies is dimensionally similar to cited predicate devices.
Sterilization
The Aries® Lumbar Interbodies is provided sterile and cited predicate devices are sterile
for single use only.
Performance Specification
Mechanical testing confirmed the Aries® Lumbar Interbodies demonstrated equivalent
performance to the cited predicate device under the same test conditions.
Non-clinical Test
Summary	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 recommended
maximum endotoxin level of 20 EU per device.
The results of these evaluations indicate that the Aries® Lumbar Interbodies are equivalent
to predicate devices. |
| Clinical Test
Summary | No clinical studies were performed |
| Conclusions: Non-
clinical and Clinical | Osseus Fusion Systems considers the Aries® Lumbar Interbodies 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 |

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