(119 days)
Not Found
No
The summary describes a physical implant and associated instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an interbody fusion system designed to provide structural stability following a discectomy, which is a therapeutic intervention for spinal conditions.
No.
The device is an interbody fusion system designed to provide structural stability, not to diagnose medical conditions.
No
The device description explicitly states it consists of an interbody cage, screws, locking mechanism, and instrumentation, all of which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is a physical implantable device (an interbody cage, screws, and instrumentation) used in surgery to provide structural stability in the spine.
- Intended Use: The intended use describes a surgical procedure for spinal fusion, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is an interbody fusion device system placed via a variety of open or minimally invasive approaches and indicated for use:
- · In skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1)
- · In patients having have received 6 months of nonoperative treatment prior to treatment
- With or without screws
- · With autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft
Standalone Use (with screws)
ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for stand-alone use in patients with DDD or with degenerative spondylolisthesis at one or two contiguous levels only when used with (1) at least three screws per implant (including at least one screw in each endplate) and (2) when ≤ 20° lordotic implants are used.
Use with Supplemental Fixation (with or without screws)
ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for use with supplemental fixation in patients with Degenerative disc disease (DD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, Spinal deformity (degenerative scoliosis), Spondylolisthesis or retrolisthesis, or failed previous fusion (pseudoarthrosis).
When used at more than 2 contiguous levels, with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
OVD, MAX
Device Description
The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is an integrated anterior lumbar interbody fusion device used to provide structural stability following discectomy.
The system consists of an interbody cage additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001, screws and locking mechanism manufactured from Titanium-6 Aluminum-4 ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899.
The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System cages are offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2-S1)
Indicated Patient Age Range
skeletally mature patients
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)
The mechanical performance profile of the ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System was assessed through static and dynamic construct testing in accordance with the following test methods:
- Static and dynamic compression testing (ASTM F2077-18) .
- . Static and dynamic compression shear testing (ASTM F2077-18)
- . Subsidence testing (ASTM F2267-04)
- Expulsion testing (ASTM Draft Standard F-04.25.02.02) .
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.
HEDRON IA TM Integrated Lumbar Spacers - Globus Medical (K191391), MiRus 3D Printed Lumbar Interbody Fusion Systems - MiRus, LLC (K191906)
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.
Not Found
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
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
May 13, 2022
MiRus, LLC Mr. Jordan Bauman Vice President, Regulatory Affairs 1755 West Oak Parkway, Suite 100 Marietta, Georgia 30062
Re: K220115
Trade/Device Name: ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: April 8, 2022 Received: April 11, 2022
Dear Mr. Bauman:
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.
1
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 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.
for 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
510(k) Number (if known) K220115
Device Name
ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System
Indications for Use (Describe)
The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is an interbody fusion device system placed via a variety of open or minimally invasive approaches and indicated for use:
- · In skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1)
- · In patients having have received 6 months of nonoperative treatment prior to treatment
- With or without screws
- · With autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft
Standalone Use (with screws)
ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for stand-alone use in patients with DDD or with degenerative spondylolisthesis at one or two contiguous levels only when used with (1) at least three screws per implant (including at least one screw in each endplate) and (2) when ≤ 20° lordotic implants are used.
Use with Supplemental Fixation (with or without screws)
ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for use with supplemental fixation in patients with Degenerative disc disease (DD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, Spinal deformity (degenerative scoliosis), Spondylolisthesis or retrolisthesis, or failed previous fusion (pseudoarthrosis).
When used at more than 2 contiguous levels, with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.
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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3
510(k) Summary K220115
1. 510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| I. SUBMITTER | MiRus ™, LLC |
|---|---|
| 1755 West Oak Parkway | |
| Suite 100 | |
| Marietta, Georgia 30062 | |
| Tel: (678) 324-6272 | |
| Fax: (678) 401-5607 | |
| II. OFFICIAL CORRESPONDENT | Jordan Bauman |
| Vice President, Regulatory Affairs | |
| MiRus ™, LLC | |
| 1755 West Oak Parkway | |
| Suite 100 | |
| Marietta, Georgia 30062 | |
| Tel: (678) 324-6272 | |
| Fax: (678) 401-5607 | |
| III. DATE PREPARED | April 08, 2022 |
| IV. DEVICE | |
| Name of Device | ANTARES 3DR ™ Standalone Anterior Lumbar Interbody Fusion System |
| Common Name | Intervertebral body fusion device |
| Classification Name | 21 CFR 888.3080 |
| Regulatory Class | Class II |
| Product Codes | OVD, MAX |
V. PREDICATE DEVICE
| Primary Predicate | HEDRON IA TM Integrated Lumbar Spacers - Globus Medical (K191391) |
|---|---|
| Additional Predicate Device | MiRus 3D Printed Lumbar Interbody Fusion Systems - MiRus, LLC (K191906) |
Traditional 510(k)
VI. DEVICE DESCRIPTION
Submission Type
The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is an integrated anterior lumbar interbody fusion device used to provide structural stability following discectomy.
The system consists of an interbody cage additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001, screws and locking mechanism manufactured
4
from Titanium-6 Aluminum-4 ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899.
The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System cages are offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.
VII. INDICATIONS FOR USE
The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is an interbody fusion device system placed via a variety of open or minimally invasive approaches and indicated for use:
- In skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1)
- . In patients having have received 6 months of nonoperative treatment prior to treatment
- With or without screws
- . With autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft
Standalone Use (with screws)
ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for stand-alone use in patients with DDD or with degenerative spondvlolisthesis at one or two contiguous levels only when used with (1) at least three screws per implant (including at least one screw in each endplate) and (2) when ≤ 20° lordotic implants are used.
Use with Supplemental Fixation (with or without screws)
ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for use with supplemental fixation in patients with Degenerative disc disease (DDD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, Spinal deformity (degenerative scoliosis), Spondylolisthesis or retrolisthesis, or failed previous fusion (pseudoarthrosis).
When used at more than 2 contiguous levels, with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.
VIII. PREDICATE DEVICE COMPARISON
The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System and the predicate device have the same intended use, indications for use, design functions, material composition, range of sizes, and instrumentation. The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System and the predicate device are additively manufactured from titanium alloy per ASTM F3001. In terms of design features, the predicate system is limited to a 3-screw hole configuration whereas the ANTARES 3DR ™ Standalone Anterior Lumbar Interbody Fusion System consists of a 6-screw hole design that allows for the surgeon to choose configurations most suitable for a wide range of patients.
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IX. PERFORMANCE DATA
The mechanical performance profile of the ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System was assessed through static and dynamic construct testing in accordance with the following test methods:
- Static and dynamic compression testing (ASTM F2077-18) .
- . Static and dynamic compression shear testing (ASTM F2077-18)
- . Subsidence testing (ASTM F2267-04)
- Expulsion testing (ASTM Draft Standard F-04.25.02.02) .
X. CONCLUSIONS
The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System has the same intended use, indications for use, labeling, and technological characteristics as the predicate system, including the same design features, geometries, sizes, and materials. Performance data demonstrate that the ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is substantially equivalent to legally marketed predicate systems.