(272 days)
No
The device description focuses on the materials, dimensions, and intended use of a metallic plating and screw system for bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies, which directly addresses a medical condition and facilitates healing.
No
Explanation: The device is a plating system intended to stabilize and aid in the repair of fractures, fusions, and osteotomies. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "metallic plate and screw system," which are hardware components, not software.
Based on the provided information, the ATLAS™ Plating System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for stabilizing and aiding in the repair of fractures, fusions, and osteotomies of bones. This is a surgical implant used in vivo (within the body) for structural support and fixation.
- Device Description: The description details metallic plates and screws made from specific alloys, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The ATLAS™ Plating System is a surgical implant used in vivo.
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 bones and bone fragments in adult and pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Mechanical testing for screws (ASTM F543-17)
Mechanical testing for plates (ASTM F382-17)
Performance data demonstrate that the ATLAS™ Plating System is substantially equivalent legally marketed predicate devices.
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.
MINI MAXLOCK Extreme Plating System (K121437), ATLAS™ Plating System (K190415), ORTHOLOC® 3Di Small Bones Plating System (K163039)
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.
EUROPA™ Pedicle Screw System (K130337)
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
§ 888.3030 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
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
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 9, 2020 |
| IV. DEVICE
Name of Device
Common Name
Classification Name
Regulatory Class
Product Codes
Submission Type | ATLAS™ Plating System
Fixation Bone Screw System
21 CFR §888.3030 Single/multiple component
metallic bone fixation appliances and accessories
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 Predicate
ATLAS™ Plating System (K190415)
ORTHOLOC® 3Di Small Bones Plating System
(K163039) |
| | Reference Device
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.