(74 days)
Not Found
No
The device description focuses on mechanical components (plates, screws, buttons) and their materials and dimensions. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an internal bone fixation system for fractures, fusions, osteotomies, and non-unions, which are all therapeutic interventions.
No
The device is described as an internal bone fixation system (plates, screws, and buttons) used for treating fractures and other bone conditions. Its function is to fix and stabilize bones, not to diagnose medical conditions.
No
The device description explicitly states it is a family of stainless steel plates, screws, and buttons, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "internal bone fixation for bone fractures, fusions, osteotomies, and non-unions." This describes a surgical implant used to treat musculoskeletal conditions.
- Device Description: The device is described as "stainless steel plates, screws, and buttons." These are physical implants used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with bodily specimens in this way.
The Arthrex Fracture System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Fracture System is 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, femur, and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws.
The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 FiberWire or FiberTape.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Arthrex Fracture System is a family of stainless steel plates, screws, and buttons that will be offered as sterile or non-sterile devices. The plates may be contoured or straight and may be available in left and right configurations. The screw family ranges from 2.7mm to 4.0mm in diameter and from 8mm to 80mm in length. The screws are solid and fully threaded and may be locking or non-locking. The button is stainless steel and designed to fit securely in the holes of the fracture plates. The button is intended to be used with the previously cleared suture, which is provided separately.
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, 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)
Not Found
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
Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2015
Arthrex, Inc. David L. Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K143139 Trade/Device Name: Arthrex Fracture System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: December 15, 2014 Received: December 17, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. David L. Rogers
forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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 System
Indications for Use (Describe)
The Arthrex Fracture System is 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, femur, and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws.
The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 FiberWire or FiberTape.
Type of Use (Select one or both, as applicable)
Ø 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)
FORM FDA 3881 (9/13)
PSC Publishing Services (301) 443-6
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| 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | |
|---|---|
| Date Summary Prepared | January 15, 2015 |
| 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 System |
| Common Name | Plate, fixation, bone |
| 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 | K112437: Arthrex Fracture System |
| Purpose of Submission | This special 510(k) premarket notification is intended |
| to address the use of Gamma Irradiation and Ethylene | |
| Oxide sterilization on the Arthrex Fracture System | |
| devices, which were originally cleared as non-sterile | |
| devices under K112437. The intended use, material, | |
| and fundamental technological characteristics of the | |
| proposed Arthrex Fracture System are substantially | |
| equivalent to the non-sterile predicates. | |
| Device Description | The Arthrex Fracture System is a family of stainless |
| steel plates, screws, and buttons that will be offered | |
| as sterile or non-sterile devices. The plates may be | |
| contoured or straight and may be available in left and | |
| right configurations. The screw family ranges from | |
| 2.7mm to 4.0mm in diameter and from 8mm to 80mm | |
| in length. The screws are solid and fully threaded and | |
| may be locking or non-locking. The button is stainless | |
| steel and designed to fit securely in the holes of the | |
| fracture plates. The button is intended to be used | |
| with the previously cleared suture, which is provided | |
| separately. | |
| Intended Use | The Arthrex Fracture System is 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, femur, and fibula. The Arthrex | |
| Fracture Plates are to be used with the 2.7mm-4.0mm | |
| Arthrex Low Profile Screws. | |
| The Clavicle Plate Button is intended for use with the | |
| clavicle plates for clavicle indications such as for the | |
| treatment of syndesmotic trauma, such as fixation of | |
| acromioclavicular separations due to coracoclavicular | |
| ligament disruption, and this button may not be used | |
| alone. The button is intended to be used with #5 | |
| FiberWire or FiberTape. | |
| Substantial Equivalence Summary | The Arthrex Fracture System is substantially |
| equivalent to the predicate devices in which the basic | |
| design features and intended uses are the same. Any | |
| differences between the Arthrex Fracture System 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 devices will undergo Gamma | |
| Irradiation or Ethylene Oxide (EO) sterilization. | |
| Based on the indications for use, technological | |
| characteristics, and the summary of data submitted, | |
| Arthrex, Inc. has determined that the Arthrex Fracture | |
| System is substantially equivalent to the predicates. |
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