(60 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.
No
The device is used for internal bone fixation for fractures, fusions, or osteotomies, which is a structural or supportive function rather than a therapeutic one that would directly treat a disease or condition.
No
Explanation: The device is described as an internal bone fixation system (plates and screws) intended for treating bone fractures, fusions, or osteotomies. This is a therapeutic function, not a diagnostic one. While MRI testing is mentioned, it is for compatibility of the implant with MRI, not for the device itself to perform diagnostics.
No
The device description explicitly states that the device consists of physical plates and screws made from titanium alloy, which are hardware components.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Arthrex MaxForce MTP Compression Plates and Screws are implants used for internal bone fixation for fractures, fusions, and osteotomies. They are physically placed within the body to stabilize bone.
- Lack of Specimen Testing: There is no mention of the device being used to test or analyze any biological specimens.
- Focus on Mechanical Properties and MRI Compatibility: The performance studies focus on the mechanical strength of the plates and screws (bend, fatigue, pull-out, torque) and their compatibility with MRI, which are relevant for implanted medical devices, not IVDs.
Therefore, based on the provided information, the Arthrex MaxForce MTP Compression Plates and Screws are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Arthrex MaxForce MTP Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the Forefoot.
The Arthrex Low Profile Screws (2.0-3.0mm 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 screws may be used with the Arthrex Low Profile Plates and MaxForce MTP Compression Plates.
The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and with a plate, the screws may be used with the Arthrex Low Profile Plates, Humeral Fracture Plates, Osteotomy Plates, and MaxForce MTP Compression Plates.
Product codes
HRS, HWC
Device Description
The Arthrex MaxForce MTP Compression Plates and Screws consists of a series of plates and screws of varying lengths and diameters. The plates are contoured to fit the various aspects of the metatarsals including Petite, Standard, Long, X-Long and Revision with 0° and 5° Valgus and Dorsiflex in left and right configurations. The plates are manufactured from titanium alloy conforming to ASTM F136. The plates are attached to bone with 3.0 mm cortical, 3.0 mm cortical, hybrid and 3.0 mm variable locking screws. The screws range from 3.0 mm to 3.5 mm in diameter and from 10 mm to 26 mm in length. The screws are manufactured from titanium alloy conforming to ASTM F136. The 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
Forefoot, ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula.
Indicated Patient Age Range
Not Found
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)
Engineering analysis, Static Four-Point Bend (ASTM F382), Four-Point Bend Fatigue (ASTM F382), and plate/instrument compression testing were conducted on the subject plates. Pull-out strength testing (ASTM F543), torsional strength testing (ASTM F543) and Insertion Torque testing were conducted on the subject screws. The testing demonstrates that the Arthrex MaxForce MTP Compression Plates and Screws performs statistically equivalent to the predicate devices cleared under K130510, K111253 and K103705.
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.
The submitted mechanical testing data demonstrates that the Static Four-Point Bend, Four-Point Bend Fatigue, Compression Force, Compression Distance, Pull-out and Torque strength of the Arthrex MaxForce MTP Compression Plates and Screws is substantially equivalent to that of the predicate devices for the desired indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
Arthrex Inc. Rebecca Homan Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K201235
Trade/Device Name: Arthrex MaxForce MTP Compression Plates and Screws 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: May 4, 2020 Received: May 7, 2020
Dear Rebecca Homan:
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 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
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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.
For
Shumava 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
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Indications for Use
510(k) Number (if known) K201235
Device Name
Arthrex MaxForce MTP Compression Plates and Screws
Indications for Use (Describe)
The Arthrex MaxForce MTP Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the Forefoot.
The Arthrex Low Profile Screws (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a platescrew 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 screws may be used with the Arthrex Low Profile Plates and MaxForce MTP Compression Plates.
The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and with a plate, the screws may be used with the Arthrex Low Profile Plates, Humeral Fracture Plates, Osteotomy Plates, and MaxForce MTP Compression Plates.
| 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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510(k) Summary
| Date Prepared | July 6, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex MaxForce MTP Compression Plates and Screws |
| 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 Classification); | |
| 21 CFR 888.3040: Smooth or Threaded metallic bone fixation fastener | |
| Regulatory Class | II |
| Predicate Devices | K130510: Arthrex Compression Plates (Primary Predicate) |
| K111253: Arthrex Distal Extremity Plate System | |
| K103705: Arthrex Low Profile Screws | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex MaxForce MTP Compression Plates and Screws. | |
| Device Description | The Arthrex MaxForce MTP Compression Plates and Screws consists of a series of |
| plates and screws of varying lengths and diameters. The plates are contoured to | |
| fit the various aspects of the metatarsals including Petite, Standard, Long, X-Long | |
| and Revision with 0° and 5° Valgus and Dorsiflex in left and right configurations. | |
| The plates are manufactured from titanium alloy conforming to ASTM F136. The | |
| plates are attached to bone with 3.0 mm cortical, 3.0 mm cortical, hybrid and 3.0 | |
| mm variable locking screws. The screws range from 3.0 mm to 3.5 mm in | |
| diameter and from 10 mm to 26 mm in length. The screws are manufactured | |
| from titanium alloy conforming to ASTM F136. The plates and screws are sold | |
| non-sterile and single-use. | |
| Indications for Use | The Arthrex MaxForce MTP Compression Plates are intended to be used for |
| internal bone fixation for bone fractures, fusions, or osteotomies in the Forefoot. |
The Arthrex Low Profile Screws (2.0-3.0mm 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 screws may be used with the Arthrex Low
Profile Plates, Small Fragment Plates and MaxForce MTP Compression Plates.
The Arthrex Low Profile Screws (3.5mm and larger, 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,
wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur
and fibula. When used with a plate, the screws may be used with the Arthrex
Low Profile Plates, Small Fragment Plates, Humeral Fracture Plates, Osteotomy
Plates, and MaxForce MTP Compression Plates. |
| | |
| Performance Data | Engineering analysis, Static Four-Point Bend (ASTM F382), Four-Point Bend
Fatigue (ASTM F382), and plate/instrument compression testing were conducted
on the subject plates. Pull-out strength testing (ASTM F543), torsional strength
testing (ASTM F543) and Insertion Torque testing were conducted on the subject
screws. The testing demonstrates that the Arthrex MaxForce MTP Compression
Plates and Screws performs statistically equivalent to the predicate devices
cleared under K130510, K111253 and K103705.
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 MaxForce MTP Compression Plates and Screws are substantially
equivalent to the predicate devices in which the basic design features, intended
use, fundamental scientific technology, indications for use, sterility, packaging,
and shelf-life are identical.
The Arthrex MaxForce MTP Compression Plates are contoured to fit the various
aspects of the metatarsals including Petite, Standard, Long, X-Long and Revision
with 0° and 5° Valgus and Dorsiflex in left and right configurations. The
predicate Arthrex Compression Plates cleared under K130510 are
contoured to fit the various aspects of the foot, ankle, hand and wrist
including Square, Linear, T- configurations. The predicate Arthrex
Contoured Plates cleared under K111253 are contoured to fit the metatarsals
including Petite, Standard, and Long in left and right configurations.
The Arthrex MaxForce MTP Compression Plates and Screws are manufactured
from titanium; whereas the predicate Arthrex Compression Plates cleared under
K130510 are manufactured from stainless steel. However, the titanium alloy
used to manufacture the Arthrex MaxForce MTP Compression Plates and Screws
is identical is identical to the titanium alloy cleared for the Arthrex Contoured
Plates cleared under K111253.
The Arthrex MaxForce MTP Compression Plates and Screws were evaluated for
MR Conditional labeling; whereas the predicate devices were not evaluated for
MR Conditional labeling. |
| Conclusion | The Arthrex MaxForce MTP Compression Plates and Screws are substantially
equivalent to the predicate devices in which the basic design features and
intended uses are the same. Any differences between the proposed devices and
the predicate devices are considered minor and do not raise different questions
concerning safety or effectiveness. |
| The Arthrex MaxForce MTP Compression Plates and Screws MR compatibility
testing supports the devices MR Conditional labeling. There is no increased risk
from this difference in technology. | |
| The submitted mechanical testing data demonstrates that the Static Four-Point
Bend, Four-Point Bend Fatigue, Compression Force, Compression Distance, Pull-
out and Torque strength of the Arthrex MaxForce MTP Compression Plates and
Screws is 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 devices are
substantially equivalent to the currently marketed predicate devices. | |
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