(34 days)
Not Found
No
The device description and intended use clearly describe physical implants (plates and screws) for bone fixation. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML. The performance studies focus on mechanical properties.
No
The device is described as fracture plates and screws used for internal bone fixation, which are structural devices for support rather than devices that provide therapeutic treatment.
No
The device is described as plates and screws used for internal bone fixation (fractures, fusions, osteotomies, non-unions), indicating it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description explicitly states that the device is a family of titanium and stainless steel plates and screws, which are physical 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 Arthrex Fracture Plates and Screws are for the internal fixation of 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 titanium and stainless steel) designed to be surgically implanted.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens.
The device described is a surgical implant used for orthopedic procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Arthrex Fracture Plates are intended to be used for internal bone froctures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.
The Arthrex Low Profile Screws (2.0-2.4mm 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates.
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-olone bone screws for internal bone fixation for bone froctures, fusions, ostectomies, and non-unions in the ankle, foot, hand, and wrist.
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 fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, alecranon, hymerus, radius, ulno, tibig, colconeous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Smoll Fragment Plates, distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clovicle, scapula, olecranon, humerus, radius, ulna, tibia, calconeous, femur, and fibula.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Arthrex Fracture Plates and Screws are a family of titanium and stainless steel plates and screws. The plates are flat and contoured, ranging from 50mm to 244mm in length. The accompanying screws are 2.0mm to 6.7mm in diameter.
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, fibula, femur
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)
The engineering analysis conducted on the distal fibula plates demonstrates that there is no significant difference in bending strength between the Arthrex Distal Fibula Plates and the predicate.
The screw torsion and pullout testing conducted on the additional screws demonstrates that the torsional properties and pullout strength are higher or equivalent to the predicate.
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.
Not Found
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.
0
JUL 0882014
| Date Summary Prepared | July 8, 2014 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | David L.Rogers |
| Regulatory Affairs Associate | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 71924 | |
| Fax: 239/598.5508 | |
| Email: david.rogers@Arthrex.com | |
| Trade Name | Arthrex Fracture Plates and Screws |
| Common Name | Fastener, fixation, nondegradable soft tissue |
| Product Code -Classification Name | HRS - Plate, Fixation, Bone |
| HWC - Screw, Fixation, Bone | |
| CFR | 21 CFR 888.3030: 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 |
| K103705: Arthrex Low Profile Screws | |
| Purpose of Submission | This special 510(k) premarket notification is submitted to |
| obtain FDA clearance for the use of Gamma Irradiation | |
| and Ethylene Oxide sterilization for the Arthrex Fracture | |
| Plates and Screws, which were cleared as non-sterile | |
| devices through K123241. | |
| This special 510(k) premarket notification is also intended | |
| to address the addition of the Arthrex Distal Fibula | |
| Plates, the Arthrex Low Profile Screws (4.5, 5.5, & 6.0), | |
| the Arthrex 2.7 Low Profile Cortical Screws, and the | |
| Arthrex 6.7 Low Profile Screws as line extensions to | |
| K123241, which are similar in design, and identical in | |
| material and intended use. | |
| Device Description | The Arthrex Fracture Plates and Screws are a family of |
| titanium and stainless steel plates and screws. The plates | |
| are flat and contoured, ranging from 50mm to 244mm in | |
| length. The accompanying screws are 2.0mm to 6.7mm | |
| in diameter. | |
| Intended Use | The Arthrex Fracture Plates and Screws are intended to |
| be used for internal bone fixation. See Indications for | |
| Use pages for specific indications. | |
| Substantial Equivalence Summary | The Arthrex Fracture 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 Arthrex Fracture Plates and | |
| Screws and the predicates are considered minor and do | |
| not raise questions concerning safety and effectiveness. | |
| The predicate devices are cleared as non-sterile devices. | |
| The proposed plates will undergo Gamma Irradiation or | |
| Ethylene Oxide (EO) sterilization. | |
| The engineering analysis conducted on the distal fibula | |
| plates demonstrates that there is no significant difference | |
| in bending strength between the Arthrex Distal Fibula | |
| Plates and the predicate. | |
| The screw torsion and pullout testing conducted on the | |
| additional screws demonstrates that the torsional | |
| properties and pullout strength are higher or equivalent | |
| to the predicate. | |
| Based on the indications for use, technological | |
| characteristics, and the summary of data submitted, | |
| Arthrex, Inc. has determined that the Arthrex Fracture | |
| Plates and Screws are substantially equivalent to the | |
| predicates. |
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and the state of the state of the states and
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MI) 20993-0002
July 8, 2014
Arthrex, Inc. Mr. David L. Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108
Re: K141478
Trade/Device Name: Arthrex Fracture 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: June 12, 2014 Received: June 13. 2014
Dear Mr. Rogers:
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
3
Page 2 - Mr. David L. Rogers
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2.5 INDICATIONS FOR-USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-01 Expiration Date: December 31, 201 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Arthrex Fracture Plates and Screws
Indications for Use (Describe)
The Arthrex Fracture Plates are intended to be used for internal bone froctures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.
The Arthrex Low Profile Screws (2.0-2.4mm 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates.
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-olone bone screws for internal bone fixation for bone froctures, fusions, ostectomies, and non-unions in the ankle, foot, hand, and wrist.
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 fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, alecranon, hymerus, radius, ulno, tibig, colconeous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Smoll Fragment Plates, distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clovicle, scapula, olecranon, humerus, radius, ulna, tibia, calconeous, femur, and fibula.
Type of Use (Select one or both, as applicable)
0 Prescription Use {Part 21 CFR 801 Subpart D}
0 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) (Signalure)
Elizabeth @Frank -S
Division of Orthopedic Devices
FORM FDA 3881 (9/13)
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