(63 days)
No
The summary describes standard orthopedic implants (plates and screws) and their mechanical testing, with no mention of AI or ML capabilities.
No.
The device is described as an internal bone fixation system (plates and screws) used for bone fractures, fusions, osteotomies, and non-unions, which is a structural support device rather than one that delivers therapy or treatment in a therapeutic sense.
No
This device is intended for internal bone fixation for fractures and fusions, not for diagnosing medical conditions.
No
The device description explicitly states that the device is comprised of physical components (plates and screws made of stainless steel) intended for surgical implantation.
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 is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details physical implants (plates and screws) made of stainless steel, designed for surgical 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.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is an implantable surgical device used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The Arthrex Fracture Plates are intended to be used 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, and fibula.
The Arthrex Low Profile Screws (2.5mm 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.
Product codes
HRS, HWC
Device Description
The Arthrex Fracture Plates are a family of flat and contoured plates and screws. The plates are comprised of stainless steel and come in a variety of configurations. The Arthrex Fracture Plates are intended to be used with solid locking and non-locking Low Profile Screws. The proposed Low Profile Screws, in this submission, are comprised of Stainless Steel and are 2.7mm in diameter and range from 32mm to 60mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula. Additionally, femur (for Low Profile Screws).
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)
The submitted in-vitro testing (4-point bend, section modulus comparison, torque) demonstrates that the performance of the proposed devices is substantially equivalent to that of the predicate devices. The mechanical data indicate that the Arthrex Fracture Plates are adequate for their intended use. Clinical data and conclusions are not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K123241 - Arthrex Fracture Plates, K141478 - Arthrex Fracture Plates and Screws
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 shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and appear to be connected by flowing lines at the bottom. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2015
Arthrex, Incorporated Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108
Re: K151732 Trade/Device Name: Arthrex Fracture 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: June 20, 2015 Received: July 31, 2015
Dear Ms. Smith:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix 1
2.5 INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K151732
Device Name
Arthrex Fracture Plates
Indications for Use (Describe)
The Arthrex Fracture Plates are intended to be used 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, and fibula.
The Arthrex Low Profile Screws (2.5mm 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | |
|---|---|
| ------------------ | -- |
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
PSC Publishing Services (301) 443-6740 EP
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| Date Summary Prepared | August 20, 2015 |
|---|---|
| Manufacturer/ | |
| Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Manager, Regulatory Affairs | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext.71720 | |
| Fax: 239/598.5508 | |
| Email: Courtney.Smith@Arthrex.com | |
| Trade Name | Arthrex Fracture Plates |
| Common Name | Plate, fixation, bone |
| Product Code, | |
| Classification Name, CFR | HWC, HRS |
| 21 CFR 888.8030: Single/multiple component metallic bone | |
| fixation appliances and accessories | |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation | |
| fastener | |
| Predicate Device | K123241 - Arthrex Fracture Plates |
| K141478 - Arthrex Fracture Plates and Screws | |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtain |
| clearance for Arthrex Fracture Plates and the accompanying | |
| screws. | |
| Device Description | The Arthrex Fracture Plates are a family of flat and contoured |
| plates and screws. The plates are comprised of stainless steel and | |
| come in a variety of configurations. The Arthrex Fracture Plates are | |
| intended to be used with solid locking and non-locking Low Profile | |
| Screws. The proposed Low Profile Screws, in this submission, are | |
| comprised of Stainless Steel and are 2.7mm in diameter and range | |
| from 32mm to 60mm in length. | |
| Intended Use | The Arthrex Fracture Plates are intended to be used 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, and fibula. | |
| The Arthrex Low Profile Screws (2.5mm 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. | |
| Substantial | |
| Equivalence Summary | The Arthrex Fracture Plates are substantially equivalent to the |
| predicate devices in which the basic design features and intended | |
| uses are the same. Any differences between the Arthrex Fracture | |
| Plates and the predicates are considered minor and do not raise | |
| questions concerning safety and effectiveness. | |
| The proposed devices are substantially equivalent to the predicate | |
| devices in regards to its intended use, design, size range, and | |
| material. The submitted in-vitro testing (4-point bend, section | |
| modulus comparison, torque) demonstrates that the performance | |
| of the proposed devices is substantially equivalent to that of the | |
| predicate devices. The mechanical data indicate that the Arthrex | |
| Fracture Plates are adequate for their intended use. Clinical data | |
| and conclusions are not needed for this device. | |
| Based on the indication for use, technological characteristics, and | |
| the comparison to the predicate device, Arthrex, Inc. has | |
| determined that the Arthrex Fracture Plates are substantially | |
| equivalent to currently marketed predicate devices. |
2.5 510K SUMMARY OF SAFETY AND EFFECTIVENESS
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