(86 days)
No
The summary describes a system of bone plates and screws for internal fixation, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as internal bone fixation for fractures, fusions, osteotomies, and non-unions, which are medical conditions that require treatment.
No
Explanation: The device is described as internal bone fixation for bone fractures, fusions, osteotomies, and non-unions, and is composed of contoured plates and screws. These are therapeutic implants, not devices used to diagnose a medical condition.
No
The device description explicitly states that the device is comprised of physical components (plates and screws) made from Titanium.
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 devices are for "internal bone fixation for bone fractures, fusions, osteotomies and non-unions". This describes a surgical procedure performed directly on the patient's body to stabilize bones.
- Device Description: The device description details plates and screws made of titanium, designed for physical 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 treatment. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Therefore, the Arthrex Pilon Fusion Plates and Low Profile Screws are medical devices intended for surgical implantation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Arthrex Pilon Fusion Plates are intended to be internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, tibia, and calcaneous.
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, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates and Osteotomy Plates.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Arthrex Pilon Fusion Plate System are a family of contoured plates and screws. The Arthrex Pilon Fusion Plates are manufactured from Titanium conforming to ASTM F136 and are available in a variety of configurations. The Arthrex Pilon Fusion Plates are intended to be used with solid locking and non-locking Low Profile Screws. The proposed plates are sold sterile or non-sterile and single use.
The proposed Arthrex Low Profile Screws are offered in a 3.5mm diameter, length range of 85 to 120 mm, in a solid and fully threaded design. The screws are manufactured from Titanium conforming to ASTM F136 and are sold sterile or non-sterile and single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle, foot, tibia, calcaneous, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, femur, 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)
Insertion torque and failure torque, per ASTM F543, was conducted to demonstrate that the proposed screws perform statistically equivalent to the predicate In-vitro testing (4-point bend) per ASTM E382 Annex A1 & A2 was performed on the proposed plates to demonstrate that the performance of the proposed plates is substantially equivalent to that of the predicate devices.
Pull-out testing and insertion torque/failure torque testing was conducted on the previously cleared 3.5 mm Arthrex Low Profile Screws to demonstrate that the design modifications do not affect the safety or performance.
MR compatibility testing was also conducted per ASTM F2052-15 (displacement force), ASTM F2213-17 (torque), ASTM F2119-13 (image artifact), and ASTM F2182-11a (RF Heating).
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.
K103705, K111253, K123241, K131474, K143614, K150456
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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February 3, 2021
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Arthrex Inc. Samantha Passman Regulatory Affairs Associate Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K203294
Trade/Device Name: Arthrex Pilon Fusion 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: November 2, 2020 Received: November 9, 2020
Dear Samantha Passman:
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
List of Cleared Devices in K203294
2
List of Cleared Devices in K203294
-
- Arthrex Pilon Fusion Plates
- Arthrex Low Profile
3
Indications for Use
510(k) Number (if known) K203294
Device Name Arthrex Pilon Fusion Plates
Indications for Use (Describe)
The Arthrex Pilon Fusion Plates are intended to be internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, tibia, and calcaneous.
| 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."
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K203294
Device Name Arthrex Low Profile Screws
Indications for Use (Describe)
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, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates and Osteotomy Plates.
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."
FORM FDA 3881 (7/17)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
5
510(k) Summary
| Date Prepared | January 8, 2021 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Samantha Passman |
| Regulatory Affairs Associate Specialist | |
| 1-239-643-5553, ext. 71595 | |
| Samantha.passman@arthrex.com | |
| Name of Device | Arthrex Pilon Fusion System |
| Common Name | Plate, Fixation, Bone (Primary) |
| Screw, Fixation, Bone | |
| Product Code | HRS (Primary), HWC |
| Classification Name | 21 CFR § 888.3030 (Primary): Single/multiple component metallic bone fixation |
| appliances and accessories, 21 CFR §888.3040: Smooth or threaded metallic | |
| bone fixation fastener; Class II | |
| Regulatory Class | |
| Predicate Device | II |
| K151732: Arthrex Fracture Plates (Primary Predicate) | |
| K141735: Arthrex Ankle Fusion Plating System (Additional Predicate) | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex Pilon Fusion Plate System and additional longer length Arthrex Low | |
| Profile Screws. This submission is also intended to document the modifications | |
| made to the previously cleared 3.5 mm Arthrex Low Profile Screws cleared under | |
| K103705, K111253, K123241, K131474, K143614, and K150456. | |
| Device Description | The Arthrex Pilon Fusion Plate System are a family of contoured plates and |
| screws. The Arthrex Pilon Fusion Plates are manufactured from Titanium | |
| conforming to ASTM F136 and are available in a variety of configurations. The | |
| Arthrex Pilon Fusion Plates are intended to be used with solid locking and non- | |
| locking Low Profile Screws. The proposed plates are sold sterile or non-sterile and | |
| single use. |
The proposed Arthrex Low Profile Screws are offered in a 3.5mm diameter,
length range of 85 to 120 mm, in a solid and fully threaded design. The screws are
manufactured from Titanium conforming to ASTM F136 and are sold sterile or
non-sterile and single-use. |
| Indications for Use | The Arthrex Pilon Fusion Plates are intended to be used for internal bone fixation
for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, tibia,
and calcaneous.
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, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral
Fracture Plates and Osteotomy Plates. |
| Performance Data | Insertion torque and failure torque, per ASTM F543, was conducted to
demonstrate that the proposed screws perform statistically equivalent to the
predicate In-vitro testing (4-point bend) per ASTM E382 Annex A1 & A2 was |
| | performed on the proposed plates to demonstrate that the performance of the
proposed plates is substantially equivalent to that of the predicate devices. |
| | Pull-out testing and insertion torque/failure torque testing was conducted on the
previously cleared 3.5 mm Arthrex Low Profile Screws to demonstrate that the
design modifications do not affect the safety or performance. |
| | MR compatibility testing was also conducted per ASTM F2052-15 (displacement
force), ASTM F2213-17 (torque), ASTM F2119-13 (image artifact), and ASTM
F2182-11a (RF Heating). |
| Conclusion | The Arthrex Pilon Fusion System is 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 submitted data for the proposed Arthrex Pilon Fusion System demonstrates
that the bending strength and the torque of the proposed devices 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 devices are
substantially equivalent to the currently marketed predicate device. |
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