(90 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and MRI compatibility of the plates and screws, with no mention of AI or ML.
Yes
The device is indicated for fracture fixation, stabilization, reduction, fusions, osteotomies, and treatment of mal-unions, which are all therapeutic interventions for anatomical issues.
No
The device is described as a system of plates and screws for fracture fixation, stabilization, and reduction, indicating it is a therapeutic device, not a diagnostic one. The mention of MRI testing relates to device safety in MR environments, not its diagnostic capability.
No
The device description explicitly states it consists of physical components (plates and screws) made of Titanium Alloy. While it mentions MRI testing, this is related to the physical device's interaction with the MR environment, not the device itself being software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that this device is a system of plates and screws used for the fixation, stabilization, and reduction of bones and bone fragments within the body. This is an implantable surgical device, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
The mention of "image processing" in the context of MRI testing is related to evaluating the device's compatibility and potential artifacts within an MRI environment, not to the device itself performing image processing for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Arthrex Mini Fragment System is indicated for fracture fixation, replantation, stabilization, reduction, fusions, osteotomies, mal-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 - 21 year) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
Product codes
HRS, HWC
Device Description
The proposed Arthrex Mini Fragment System consists of a series of plates and screws of varying lengths and thicknesses. Each plate provides locking screw fixation. The proposed screws are a family of locking and non-locking screws. The proposed plates and screws are manufactured from Titanium Alloy. The proposed plates and screws are sold non-sterile and single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and small bone fragments, long bones
Indicated Patient Age Range
adult and adolescent (12 - 21 year) 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
Arthrex conducted Static 4-Point Bend (ASTM F382-17), 4-Point Fatigue Bend (ASTM F382-17), Pull-out (ASTM F543-17), Failure Torque, Insertion Torque (ASTM F543-17) and testing to demonstrate that the Arthrex Mini Fragment System performs statistically equivalent to the predicate Stryker VariAx 2 Mini Fragment System, K191412.
MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
June 29, 2022
Image /page/0/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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Arthrex Inc. Stacy Valdez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K220937
Trade/Device Name: Arthrex Mini Fragment 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 18, 2022 Received: March 31, 2022
Dear Stacy Valdez:
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, MPH 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
2
Indications for Use
510(k) Number (if known)
Device Name Arthrex Mini Fragment System
Indications for Use (Describe)
The Arthrex Mini Fragment System is indicated for fracture fixation, replantation, stabilization, reduction, fusions, osteotomies, mal-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 - 21 year) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K220937 510(k) Summary
| Date Prepared | June 28, 2022 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Stacy Valdez |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 72010 | |
| Stacy.valdez@arthrex.com | |
| Name of Device | Arthrex Mini Fragment System |
| Common Name | Plate, fixation, bone |
| Product Code | HRS (Primary), HWC |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation |
| appliances and accessories (Primary) | |
| 21 CFR 888.3040: Smooth or threaded metallic bone fastener | |
| Regulatory Class | II |
| Primary Predicate Device | K191412: VariAx 2 Mini Fragment System |
| Additional Predicate Device | K191344: Arthrex Mini Comprehensive Fixation System - 2.0 & 2.4 Module |
| K140814: Smith & Nephew EVOS Mini-Fragment Plating System | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain |
| clearance for the Arthrex Mini Fragment System. | |
| Device Description | The proposed Arthrex Mini Fragment System consists of a series of plates |
| and screws of varying lengths and thicknesses. Each plate provides locking | |
| screw fixation. The proposed screws are a family of locking and non- | |
| locking screws. The proposed plates and screws are manufactured from | |
| Titanium Alloy. The proposed plates and screws are sold non-sterile and | |
| single-use. | |
| Indications for Use | The Arthrex Mini Fragment System is indicated for fracture fixation, |
| reconstruction, replantation, stabilization, reduction, fusions, osteotomies, | |
| mal-unions, and non-unions of small bones and small bone fragments | |
| including normal and osteopenic bones in adult and adolescent (12-21 | |
| years) patients. The system is also indicated for non-load bearing | |
| stabilization and reduction of bone fragments in long bones. | |
| Performance Data | Arthrex conducted Static 4-Point Bend (ASTM F382-17), 4-Point Fatigue |
| Bend (ASTM F382-17), Pull-out (ASTM F543-17), Failure Torque, Insertion | |
| Torque (ASTM F543-17) and testing to demonstrate that the Arthrex Mini | |
| Fragment System performs statistically equivalent to the predicate Stryker | |
| VariAx 2 Mini Fragment System, K191412. | |
| MRI force, torque, and image artifact testing were conducted in | |
| accordance with FDA guidance Testing and Labeling Medical Devices for | |
| Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 | |
| Standard Test Method for Measurement of Magnetically Induced | |
| Displacement Force on Medical Devices in the Magnetic Resonance | |
| Environment, ASTM F2119 Standard Test Method for Evaluation of MR | |
| Image Artifacts from Passive Implants, ASTM F2182 Standard Test Method | |
| for Measurement of Measurement of Radio Frequency Induced Heating | |
| Near Passive Implants During Magnetic Resonance Imaging and ASTM | |
| F2213 Standard Test Method for Measurement of Magnetically Induced | |
| Torque on Medical Devices in the Magnetic Resonance Environment. | |
| Technological Comparison | The Arthrex Mini Fragment System is substantially equivalent to the |
| predicate devices cleared under K191412 in which the basic design | |
| features, intended use, fundamental scientific technology, shelf-life, and | |
| sterility are identical. |
The Arthrex Mini Fragment System is manufactured from Titanium Alloy
conforming to ASTM F136 (for Plates) and ASTM F136/F1472 (for Screws).
The primary predicate plates and screws cleared under the Stryker VariAx
2 Mini Fragment System, K191412 are manufactured from titanium alloy
and unalloyed titanium (standards unknown). The proposed Arthrex Mini
Fragment System plates are offered in lengths ranging from 35.2 – 141.1
mm. The primary predicate plates cleared under the Stryker VariAx 2 Mini
Fragment System, K191412 are offered in lengths ranging from 22 – 176
mm. The proposed Arthrex Mini Fragment System screws are offered in
diameters of 2.0 mm, 2.4mm, and 2.7 mm. The primary predicate screws
cleared under the Stryker VariAx 2 Mini Fragment System, K191412 are
offered in diameters of 2.0 mm, 2.4 mm, and 2.7 mm.
The Arthrex Mini Fragment System was evaluated for MR Conditional
labeling as were the predicate device cleared under K191412.
The Arthrex Mini Fragment is substantially equivalent to the predicate
devices cleared under K191412, with minor modifications with no change
to intended use or function. Any differences between the Arthrex Mini
Fragment System and the predicate devices are considered minor and do
not raise different questions of safety or effectiveness. |
| Conclusion | The Arthrex Mini Fragment System is substantially equivalent to the
predicate devices cleared under K191412 in which the basic design
features and intended use are the same. Any differences between the
Arthrex Mini Fragment System and the predicate devices are considered
minor and do not raise different questions of safety or effectiveness.
The submitted mechanical testing data demonstrates that the Static 4-
Point Bend Strength, 4-Point Bend strength, Pull-Out and Failure
Torque/Insertion Torque of the Arthrex Mini Fragment System is
substantially equivalent to that of the predicate device for the desired
indications.
Based on the indications for use, technological characteristics, and the
summary of data submitted, Arthrex Inc. has determined that the
proposed device is substantially equivalent to the currently marketed
predicate devices. |
4