(67 days)
No
The device description and intended use are solely focused on the physical components (plates and screws) for internal fixation. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML. The mention of image processing relates to testing for MRI compatibility, not a functional component of the device itself.
Yes
The device is described as "internal fixation for fractures and reconstruction of the small bones," which directly addresses a medical condition (fractures) and aims to restore function, meeting the definition of a therapeutic device.
No
The device is an internal fixation system for fractures and reconstruction of bones, not a diagnostic tool.
No
The device description clearly states it consists of physical plates and screws made of titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "internal fixation for fractures and reconstruction of the small bones." This describes a surgical implant used to physically stabilize bone.
- Device Description: The device is described as "a series of plates and screws" made of titanium. This aligns with the description of a surgical implant.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. There is no mention of this device interacting with or analyzing biological specimens.
- Performance Studies: The performance studies described focus on mechanical properties (bend testing), MRI compatibility, and sterility (bacterial endotoxins), which are relevant to surgical implants, not IVDs.
While the document mentions MRI image processing for testing purposes (evaluating artifacts), this is related to the device's compatibility with imaging modalities after implantation, not the device itself performing diagnostic analysis on biological samples.
N/A
Intended Use / Indications for Use
The Arthrex 2.4 mm Volar Distal Radius Plate System is internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular fractures, displaced fractures. osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application.
The Arthrex Low Profile Screws (2.4 mm, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, and Distal Radius Plates.
Product codes
HRS, HWC
Device Description
The Arthrex 2.4 mm Volar Distal Radius Plate System consists of a series of plates and screws of varying lengths and orientations. The Arthrex 2.4 mm Volar Distal Radius Plates are 2.26 mm in thickness. Each plate provides locking screw fixation. The proposed plates are manufactured from CP Grade 4 Titanium conforming to ASTM F67. The plates are sold as sterile (Gamma), single-use, and non-sterile, single-use.
The Arthrex Low Profile Screws are a family of fully threaded, solid, non-locking screws. The screw family is offered in 2.4 mm in diameter and range in lengths from 6 mm to 40 mm. The screws are manufactured from Titanium Alloy conforming to ASTM F136. The screws are sold sterile (Gamma) and are single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius and distal ulna; ankle, foot, hand, and wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Arthrex conducted 4-Point Bend (ASTM F382-17) testing to demonstrate that the Arthrex 2.4 mm Volar Distal Radius Plate System plates perform statistically equivalent to the additional predicate devices cleared under Arthrex Plates, Screws and Staples, K150456. The devices cleared under the additional predicate Arthrex Plates, Screws and Staples, K150456 were originally cleared under primary predicate Arthrex Distal Radius Plate System, K131474.
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.
Bacterial Endotoxins Test (BET) was performed on the Arthrex 2.4 mm Volar Distal Radius Plate System utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. The testing conducted demonstrates that the sterile devices within the Arthrex Plates meet pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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October 3, 2022
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Arthrex Inc. Stacy Valdez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K222267
Trade/Device Name: Arthrex 2.4 mm Volar Distal Radius Plate 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: July 23, 2022 Received: July 28, 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 (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 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K22267
Device Name
Arthrex 2.4 mm Volar Distal Radius Plate Sytem
Indications for Use (Describe)
The Arthrex 2.4 mm Volar Distal Radius Plate System is internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular fractures, displaced fractures. osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application.
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.
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."
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Indications for Use
510(k) Number (if known) K22267
Device Name Arthrex Low Profile Screws
Indications for Use (Describe)
The Arthrex Low Profile Screws (2.4 mm, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, and Distal Radius Plates.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 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."
4
510(k) Summary
| Date Prepared | September 26, 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 2.4 mm Volar Distal Radius Plate System |
| Common Name | Plate, fixation, bone |
| Screw, fixation, bone | |
| Product Code | HRS, 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 fixation fastener | |
| Regulatory Class | II |
| Predicate Device | K131474: Arthrex Distal Radius Plate System |
| Additional Predicate Device(s) | K150456: Arthrex Plates, Screws and Staples |
| Reference Device(s) | K203294: Arthrex Pilon Fusion System |
| K213837: Arthrex Ankle Fracture System | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain |
| clearance for the Arthrex 2.4 mm Volar Distal Radius Plate System. | |
| Device Description | The Arthrex 2.4 mm Volar Distal Radius Plate System consists of a series |
| of plates and screws of varying lengths and orientations. The Arthrex 2.4 | |
| mm Volar Distal Radius Plates are 2.26 mm in thickness. Each plate | |
| provides locking screw fixation. The proposed plates are manufactured | |
| from CP Grade 4 Titanium conforming to ASTM F67. The plates are sold | |
| as sterile (Gamma), single-use, and non-sterile, single-use. | |
| The Arthrex Low Profile Screws are a family of fully threaded, solid, non- | |
| locking screws. The screw family is offered in 2.4 mm in diameter and | |
| range in lengths from 6 mm to 40 mm. The screws are manufactured | |
| from Titanium Alloy conforming to ASTM F136. The screws are sold | |
| sterile (Gamma) and are single-use. | |
| Indications for Use | The Arthrex 2.4 mm Volar Distal Radius Plate System is intended for |
| internal fixation for fractures and reconstruction of the small bones, | |
| primarily including the distal radius and distal ulna. Examples of these | |
| internal fixations and reconstructions include compression fractures, | |
| intra-articular and extra-articular fractures, displaced fractures, | |
| osteotomies, non-unions and mal-unions. This system can be used for | |
| palmar, dorsal, or orthogonal application. | |
| The Arthrex Low Profile Screws (2.4 mm solid) are intended to be used | |
| as stand-alone bone screws, or in a plate-screw system for internal bone | |
| fixation for bone fractures, fusions, osteotomies and non-unions in the | |
| ankle, foot, hand, and wrist. When used with a plate, the screw may be | |
| used with the Arthrex Low Profile, Small Fragment Plates, Distal | |
| Extremity Plates, and Distal Radius Plates. | |
| Performance Data | Arthrex conducted 4-Point Bend (ASTM F382-17) testing to demonstrate |
| that the Arthrex 2.4 mm Volar Distal Radius Plate System plates perform statistically equivalent to the additional predicate devices cleared under Arthrex Plates, Screws and Staples, K150456. The devices cleared under the additional predicate Arthrex Plates, Screws and Staples, K150456 were originally cleared under primary predicate Arthrex Distal Radius Plate System, K131474. | |
| 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. | |
| Bacterial Endotoxins Test (BET) was performed on the Arthrex 2.4 mm Volar Distal Radius Plate System utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. The testing conducted demonstrates that the sterile devices within the Arthrex Plates meet pyrogen limit specifications. | |
| Technological Comparison | The Arthrex 2.4 mm Volar Distal Radius Plate System is substantially equivalent to the predicate devices cleared under K131474 in which the basic design features, intended use, fundamental scientific technology, materials, shelf-life (non-sterile only), and sterility (non-sterile only) are identical. |
| The Arthrex 2.4 mm Volar Distal Radius Plates are manufactured from CP Grade 4 Titanium conforming to ASTM F67 which is equivalent to the primary predicate Arthrex Distal Radius Plate System, K131474. The Arthrex 2.4 mm Volar Distal Radius Plates are 2.26 mm in thickness which is equivalent to the primary predicate Arthrex Distal Radius Plate System. | |
| The Arthrex Low Profile Screws are manufactured from Titanium conforming to ASTM F136 which is equivalent to the primary predicate Arthrex Distal Radius Plate System, K131474. The Arthrex Low Profile Screws are 2.4 mm in diameter which is equivalent to the primary predicate Arthrex Distal Radius Plate System, K131474. | |
| The Arthrex 2.4 mm Volar Distal Radius Plates are provided non-sterile which is equivalent to the primary predicate Arthrex Distal Radius Plate System, K131474. The Arthrex 2.4 mm Volar Distal Radius Plates are also provided sterile (Gamma). The Arthrex Low Profile Screws are provided sterile (Gamma). | |
| The non-sterile Arthrex 2.4 mm Volar Distal Radius Plates have an | |
| unlimited shelf-life which is equivalent to the primary predicate Arthrex | |
| Distal Radius Plate System, K131474. The sterile Arthrex 2.4 mm Volar | |
| Distal Radius Plates and Arthrex Low Profile Screws are labeled with a 5- | |
| year shelf-life. | |
| The Arthrex 2.4 mm Volar Distal Radius Plate System was evaluated for | |
| MR Conditional labeling. The primary predicate Arthrex Distal Radius | |
| Plate System, K131474 was not evaluated for MR Safety. | |
| The Arthrex 2.4 mm Volar Distal Radius Plate System is substantially | |
| equivalent to the predicate devices cleared under K131474, with minor | |
| modifications with no change to intended use or function. Any | |
| differences between the Arthrex 2.4 mm Volar Distal Radius Plate | |
| System and the predicate devices are considered minor and do not raise | |
| different questions of safety or effectiveness. | |
| Conclusion | The Arthrex 2.4 mm Volar Distal Radius Plate System is substantially |
| equivalent to the predicate devices cleared under K131474 in which the | |
| basic design features and intended use are the same. Any differences | |
| between the Arthrex 2.4 mm Volar Distal Radius Plate 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 4-Point | |
| Bend strength of the Arthrex 2.4 mm Volar Distal Radius Plates are | |
| substantially equivalent to that of the predicate devices 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. |
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