(57 days)
No
The description focuses on the mechanical components (plates and screws) and their materials, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a metallic plating system intended for fracture repair and stabilization, which is a structural or mechanical support function, not a therapeutic treatment of disease or condition by chemical, physical, or biological means.
No
The device is described as a metallic plate and screw system intended to stabilize and aid in the repair of fractures, fusions, and osteotomies, which are therapeutic functions, not diagnostic.
No
The device description explicitly states it is a metallic plate and screw system, which are hardware components, not software.
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, tissue) to provide information about a person's health. These tests are performed outside of the body.
- ATLAS™ Plating System Function: The ATLAS™ Plating System is a surgical implant used to physically stabilize and repair bone fractures, fusions, and osteotomies within the body. It is a mechanical device, not a diagnostic test.
The description clearly indicates its use in surgical procedures for bone repair, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
HRS, HWC
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.
The plates are available in different geometries to accommodate different patient and bone anatomies. The plates are made from Titanium alloy (Ti-15Mo Allov per ASTM F2066-18).
The screws are available in different diameters from Ø2.7mm to Ø5.5mm, non-locking or locking configurations with lengths ranging from 8mm to 60mm. All screws are manufactured from Titanium alloy (Ti-6Al-4V ELI per ASTM F136-13).
Implants are single use and the system is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones in the Foot, Ankle, Hand, and Wrist
Indicated Patient Age Range
adult and pediatric 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 following performance data were provided in support of the substantial equivalence determination.
- Mechanical testing for screws (ASTM F543)
- Mechanical testing for plates (ASTM F382)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MINI MAXLOCK Extreme Plating System (K121437), Wright ORTHOLOC 3Di LP Plates (K163044), Paragon28 Gorilla Plates (K140397), MaxLock Extreme Lateral TTC Plate (K132591)
Reference Device(s)
Globus AUTOBAHN Nailing System (K171108)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K190415
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 bone fragments in adult and pediatric patients.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
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See PRA Statement below.
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April 19, 2019
Image /page/1/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
MiRus, LLC Jordan Bauman Director of Regulatory Affairs and Quality 2150 Newmarket Parkway, Suite 108 Marietta, Georgia 30067
Re: K190415
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: February 19, 2019 Received: February 21, 2019
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
2
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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.
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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 TM, LLC
2150 Newmarket Parkway SE
Suite 108
Marietta, Georgia 30067
Tel: (678)-324-6272
Fax: (678) 401-5607 |
|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. OFFICIAL CORRESPONDENT | Jordan Bauman
Director of Regulatory Affairs and Quality
MiRus TM, LLC
2150 Newmarket Parkway SE
Suite 108
Marietta, Georgia 30067
Tel: (678)-324-6272
Fax: (678) 401-5607 |
| III. DATE PREPARED | February 19, 2019 |
| IV. DEVICE
Name of Device
Common Name
Classification Name
Regulatory Class
Product Codes
Submission Type | ATLASTM Plating System
Fixation Bone Screw System
21 CFR §888.3030 Single/multiple component
metallic bone fixation appliances and accessories
and
21 CFR §888.3040 Smooth or threaded metallic
bone fixation fastener
Class II
HRS, HWC
Traditional 510(k) |
| V. PREDICATE DEVICE | Primary Predicate
MINI MAXLOCK Extreme Plating System (K121437)
Additional Predicates
Wright ORTHOLOC 3Di LP Plates (K163044)
Paragon28 Gorilla Plates (K140397)
MaxLock Extreme Lateral TTC Plate (K132591)
Reference Device
Globus AUTOBAHN Nailing System (K171108) |
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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.
The plates are available in different geometries to accommodate different patient and bone anatomies. The plates are made from Titanium alloy (Ti-15Mo Allov per ASTM F2066-18).
The screws are available in different diameters from Ø2.7mm to Ø5.5mm, non-locking or locking configurations with lengths ranging from 8mm to 60mm. All screws are manufactured from Titanium alloy (Ti-6Al-4V ELI per ASTM F136-13).
Implants are single use and the system is provided non-sterile.
VII. INDICATIONS FOR 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.
VIII. PREDICATE DEVICE COMPARISON
The documentation provided shows that the MiRus™ Plating System is substantially equivalent to the predicate devices in intended use, indications for use, technological characteristics and labeling. The plate material and the predicate materials are made of Titanium alloys of different compositions to enhance strength.
IX. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
- Mechanical testing for screws (ASTM F543) ●
- Mechanical testing for plates (ASTM F382)
X. CONCLUSONS
The MiRus™ ATLAS™ Plating System does not raise any new questions of safety or efficacy when compared to the predicate device(s). The ATLAS™ Plating System has demonstrated that it is substantially equivalent in mechanical performance, indications for use, intended use, technological characteristics, materials and labeling to legally marketed predicate devices.