(66 days)
No
The summary describes a mechanical bone fixation plate and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for internal bone fixation for fractures, fusions, osteotomies, and non-unions, which are conditions requiring medical treatment to restore function and mitigate disease.
No
This device is a bone fixation plate used for internal bone fixation for fractures, fusions, osteotomies, and non-unions. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a physical implant (plates) made of Titanium Alloy and Stainless Steel, intended for internal bone fixation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "internal bone fixation for bone fractures, fusions, osteotomies and non-unions." This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a physical plate made of metal, designed to be implanted in the body. IVD devices are typically reagents, instruments, or systems used to examine specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device described is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Arthrex 3.5 mm Locking Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.
Product codes
HRS, HWC
Device Description
The Arthrex 3.5 mm Locking Compression Plates consists of a series of varying lengths. The Arthrex 3.5 mm Locking Compression Plates range from 70 mm to 278 mm in length and 3.5 mm in thickness. Each plate provides locking screw fixation. The proposed plates are manufactured from Titanium Alloy (ASTM F136) and Stainless Steel (ASTM F138). The proposed plates are sold as sterile (Gamma), single-use, and non-sterile, single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, foot, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, 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)
Arthrex conducted 4-Point Bend (ASTM F382-17) testing to demonstrate that the Arthrex 3.5 mm Locking Compression Plates perform statistically equivalent to the predicate devices cleared under Arthrex Fracture Plates (K123241).
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.
Arthrex Plates are tested for Bacterial Endotoxins Test (BET) 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.
Assessment of physical product attributes including product, design, size, and materials has determined that the Arthrex 3.5 mm Locking Compression Plates do not introduce additional risks or concerns regarding sterilization and shelf-life.
The submitted mechanical testing data demonstrates that the 4-Point Bend strength of the Arthrex 3.5 mm Locking Compression Plates are substantially equivalent to that of the predicate devices for the desired indications.
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.
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.
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.
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September 30, 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 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. Stacy Valdez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K222244
Trade/Device Name: Arthrex 3.5 mm Locking Compression Plates 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 25, 2022 Received: July 26, 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/cdrl-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)
Device Name Arthrex 3.5 mm Locking Compression Plates
Indications for Use (Describe)
The Arthrex 3.5 mm Locking Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.
| 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 | 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 3.5 mm Locking Compression Plates |
| Common Name | Plate, 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 | K123241: Arthrex Fracture Plates |
| Reference Device(s) | K203294: Arthrex Pilon Fusion System |
| K151732: Arthrex Fracture Plates | |
| Purpose of | |
| Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex 3.5 mm Locking Compression Plates. | |
| Device Description | The Arthrex 3.5 mm Locking Compression Plates consists of a series of |
| varying lengths. The Arthrex 3.5 mm Locking Compression Plates range from 70 | |
| mm to 278 mm in length and 3.5 mm in thickness. Each plate provides locking | |
| screw fixation. The proposed plates are manufactured from Titanium Alloy (ASTM | |
| F136) and Stainless Steel (ASTM F138). The proposed plates are sold as sterile | |
| (Gamma), single-use, and non-sterile, single-use. | |
| Indications for Use | The Arthrex 3.5 mm Locking Compression Plates are intended to be used for |
| internal bone fixation for bone fractures, fusions, osteotomies and non-unions in | |
| the ankle, foot, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, | |
| calcaneous, fibula. | |
| Performance Data | Arthrex conducted 4-Point Bend (ASTM F382-17) testing to demonstrate that the |
| Arthrex 3.5 mm Locking Compression Plates perform statistically equivalent to | |
| the predicate devices cleared under Arthrex Fracture Plates (K123241). |
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.
Arthrex Plates are tested for Bacterial Endotoxins Test (BET) 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. |
| | |
| | Assessment of physical product attributes including product, design, size, and
materials has determined that the Arthrex 3.5 mm Locking Compression Plates
do not introduce additional risks or concerns regarding sterilization and shelf-life. |
| Technological
Comparison | The Arthrex 3.5 mm Locking Compression Plates are substantially equivalent to
the predicate devices cleared under K123241 in which the basic design features,
intended use, fundamental scientific technology, materials (stainless steel only),
shelf-life, and sterility are identical. |
| | The Arthrex 3.5 mm Locking Compression Plates are manufactured from Titanium
Alloy conforming to ASTM F136 and Stainless Steel conforming to ASTM F138.
The primary predicate plates cleared under the Arthrex Fracture Plates, K123241
are manufactured from CP Grade 4 Titanium conforming to ASTM F67 and
Stainless Steel conforming to ASTM F138. The proposed Arthrex 3.5 mm Locking
Compression Plates are 3.5 mm in thickness and range from 70 mm to 278 mm in
length. The primary predicate plates cleared under the Arthrex Fracture Plates,
K123241 are offered in thicknesses ranging from 1.0 mm to 2.0/3.6 mm. |
| | The sterile Arthrex 3.5 mm Locking Compression Plates are packaged in a double
Nylon/Nylon pouch which is equivalent to the packaging configuration cleared
under reference device Arthrex Pilon Fusion System, K203294. The non-sterile
Arthrex 3.5 mm Locking Compression Plates are packaged in a Zip-Lock
Polyethylene Bag or a single Polyethylene Bag. The primary predicate plates
cleared under Arthrex Fracture Plates, K123241 are packaged in a polyethylene
pouch. |
| | The Arthrex 3.5 mm Locking Compression Plates were evaluated for MR
Conditional labeling as were the reference predicate devices cleared under
K203294. |
| | The 3.5 mm Locking Compression Plates are substantially equivalent to the
predicate devices cleared under K123241, with minor modifications with no
change to intended use or function. Any differences between the Arthrex 3.5 mm
Locking Compression Plates and the predicate devices are considered minor and
do not raise different questions of safety or effectiveness. |
| Conclusion | The Arthrex 3.5 mm Locking Compression Plates are substantially equivalent to
the predicate devices cleared under K123241 in which the basic design features
and intended use are the same. Any differences between the Arthrex 3.5 mm
Locking Compression Plates 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 3.5 mm Locking Compression 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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