ATLAS Plating System

K191867 · MiRus, LLC · HRS · Apr 9, 2020 · Orthopedic

Device Facts

• Record ID: K191867
• Device Name: ATLAS Plating System
• Applicant: MiRus, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Apr 9, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ATLAS™ Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies of small bones and bone fragments in adult and pediatric patients.

Device Story

ATLAS Plating System is a metallic bone fixation system consisting of plates and screws; used for treatment of fractures, fusions, and osteotomies in foot, ankle, hand, and wrist. Screws (2.7mm-5.5mm diameter; 8mm-60mm length) are non-locking. Plates are available in various geometries to fit patient anatomy. System is used by surgeons in clinical settings to provide mechanical stabilization of bone fragments, aiding healing. Device provides structural support to bone during recovery.

Clinical Evidence

Bench testing only. Mechanical testing was performed on screws per ASTM F543-17 and on plates per ASTM F382-17 to support substantial equivalence.

Technological Characteristics

Metallic bone fixation system. Screws: Titanium alloy (Ti-6Al-4V ELI per ASTM F136-13). Plates: MoRe® alloy (Molybdenum-47.5Rhenium per ASTM F3273-17). Non-locking screw configuration. Dimensions: Screws 2.7mm-5.5mm diameter, 8mm-60mm length. Mechanical testing per ASTM F543-17 and ASTM F382-17.

Indications for Use

Indicated for stabilization and repair of fractures, fusions, and osteotomies of small bones and bone fragments in adult and pediatric patients.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• MINI MAXLOCK Extreme Plating System (K121437)
• ATLAS™ Plating System (K190415)
• ORTHOLOC® 3Di Small Bones Plating System (K163039)

Reference Devices

• EUROPA™ Pedicle Screw System (K130337)

Submission Summary (Full Text)

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April 9, 2020

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The U.S. Food & Drug Administration logo is on the right and features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

MiRus, LLC Jordan Bauman Director of Regulatory Affairs and Quality 2150 Newmarket Parkway, Suite 108 Marietta, Georgia 30067

Re: K191867

Trade/Device Name: ATLAS Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: March 9, 2020 Received: March 10, 2020

Dear Jordan 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.

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

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

See PRA Statement below.

510(k) Number (if known)

K191867

Device Name

ATLAS™ Plating System

Indications for Use (Describe)

The ATLAS™ Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies of small bones and bone fragments in adult and pediatric patients.

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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FORM FDA 3881 (7/17) Page 1 of 1

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# 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<br>1755 West Oak Parkway<br>Suite 100<br>Marietta, Georgia 30062<br>Tel: [phone]<br>Fax: [phone] |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. OFFICIAL CORRESPONDENT | Jordan Bauman<br>Vice President, Regulatory Affairs<br>MiRus, LLC<br>1755 West Oak Parkway<br>Suite 100<br>Marietta, Georgia 30062<br>Tel: [phone]<br>Fax: [phone] |
| III. DATE PREPARED | April 9, 2020 |
| IV. DEVICE<br>Name of Device<br>Common Name<br>Classification Name<br>Regulatory Class<br>Product Codes<br>Submission Type | ATLAS™ Plating System<br>Fixation Bone Screw System<br>21 CFR §888.3030 Single/multiple component<br>metallic bone fixation appliances and accessories<br>21 CFR §888.3040 Smooth or threaded metallic bone<br>fixation fastener<br>Class II<br>HRS, HWC<br>Traditional 510(k) |
| V. PREDICATE DEVICE | Primary Predicate<br>MINI MAXLOCK Extreme Plating System (K121437)<br>Additional Predicate<br>ATLAS™ Plating System (K190415)<br>ORTHOLOC® 3Di Small Bones Plating System<br>(K163039) |
| | Reference Device<br>EUROPA™ Pedicle Screw System (K130337) |

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#### VI. DEVICE DESCRIPTION

The ATLAS™ Plating System is a metallic plate and screw system for treatment and fixation of fractures, fusions and osteotomies of bones in the Foot, Ankle, Hand, and Wrist of children (2-12 years), adolescents (12-21 years), and adults. The screws are available in different diameters from Ø2.7mm to Ø5.5mm, non-locking configurations with lengths ranging from 8mm to 60mm. All screws are manufactured from Titanium alloy (Ti-6Al-4V ELI per ASTM F136-13). The plates are available in different geometries to accommodate different patient and bone anatomies. The plates are manufactured from MoRe® alloy (Molybdenum-47.5Rhenium Alloy per ASTM F3273-17).

### VII. INDICATIONS FOR USE

The ATLAS™ Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies of small bone fragments in adult and pediatric patients.

### VIII. PREDICATE DEVICE COMPARISON

The intended use and technological characteristics of the ATLAS™ Plating System are the same as the predicate devices except for the plate material which is manufactured from MoRe® alloy (Molybdenum-47.5Rhenium Alloy per ASTM F3273-17) for enhanced strength.

### IX. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

- Mechanical testing for screws (ASTM F543-17) ●
- Mechanical testing for plates (ASTM F382-17) .

## X. CONCLUSIONS

Performance data demonstrate that the ATLAS™ Plating System is substantially equivalent legally marketed predicate devices.