(106 days)
No
The device description and intended use clearly describe a mechanical implant (screws and suture) and there is no mention of AI or ML in the provided text.
No
The device is used for internal bone fixation for fractures, fusions, osteotomies, and non-unions, and for approximation and/or ligation of soft tissue. These are reparative or supportive functions, not therapeutic as defined by treating or curing a disease.
No
The device is described as a surgical implant (screws and tape) for bone fixation, approximation, and ligation of soft tissue, which are therapeutic rather than diagnostic actions. There is no mention of the device being used to identify or determine the nature of a disease or condition.
No
The device description explicitly states that the device is a "construct that includes stainless steel, blunt tip, partially threaded, cannulated low profile screws and FiberTape," 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 Blunt Tip Screws and FiberTape are used for internal bone fixation and approximation/ligation of soft tissue. These are surgical procedures performed directly on the patient's body.
- Device Description: The device is described as a construct of screws and suture. These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are typically used in laboratories or point-of-care settings to perform tests on biological samples. This device is a surgical implant used for mechanical fixation and tissue repair within the body.
N/A
Intended Use / Indications for Use
The Arthrex Blunt Tip Screws are intended to be used as stand-alone bone screws 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 in conjunction with FiberTape, they can be used to treat patella fractures.
The Arthrex FiberTape suture products are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries. When used in conjunction with the Arthrex Blunt Tip Screws, Fiber Tape can be used to treat patella fractures.
Product codes
HTY, GAT
Device Description
The Arthrex Blunt Tip Screws with FiberTape is a construct that includes stainless steel, blunt tip, partially threaded, cannulated low profile screws and FiberTape.
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, patella
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
Arthrex. Incorporated Mr. David L. Rogers Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108
Re: K143702
Trade/Device Name: Arthrex Blunt Tip Screws with FiberTape Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, GAT Dated: January 13, 2015 Received: January 14, 2015
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Arthrex Blunt Tip Screws with FiberTape
Indications for Use (Describe)
The Arthrex Blunt Tip Screws are intended to be used as stand-alone bone screws 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 in conjunction with FiberTape, they can be used to treat patella fractures.
The Arthrex FiberTape suture products are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries. When used in conjunction with the Arthrex Blunt Tip Screws, Fiber Tape can be used to treat patella fractures.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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3
2.5 510K SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | April 6, 2015 |
|---|---|
| Manufacturer/ | |
| Distributor/ | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Sponsor | Naples, FL 34108-1945 USA |
| 510(k) Contact | David L Rogers |
| Regulatory Affairs | |
| 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 Blunt Tip Screws with FiberTape |
| Common Name | Screw, Fixation, Suture |
| Product Code, | |
| Classification Name, CFR | HWC, GAT |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | |
| 21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate Surgical Suture | |
| Predicate Device | K103705: Arthrex Low Profile Screws |
| K032245: Arthrex FiberTape Family | |
| K142442: Zimmer Magna-FX Cannulated Screw Fixation System | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex Blunt Tip Screws with FiberTape for internal bone fixation for bone | |
| fractures in the patella. | |
| Device Description | The Arthrex Blunt Tip Screws with FiberTape is a construct that includes stainless |
| steel, blunt tip, partially threaded, cannulated low profile screws and FiberTape. | |
| Intended Use | The Arthrex Blunt Tip Screws are intended to be used as stand-alone bone screws |
| 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 in conjunction with FiberTape, | |
| they can be used to treat patella fractures. | |
| The Arthrex FiberTape Family suture products are intended for use in | |
| approximation and/or ligation of soft tissue, including use of allograft tissue for | |
| orthopedic surgeries. When used in conjunction with the Arthrex Blunt Tip | |
| Screws, FiberTape can be used to treat patella fractures. | |
| Substantial | |
| Equivalence Summary | The Arthrex Blunt Tip Screws with FiberTape is substantially equivalent to the |
| predicate devices, in which the basic design features and intended uses are the | |
| same. Any differences between the Arthrex Blunt Tip Screws with FiberTape and | |
| the predicates are considered minor and do not raise questions concerning safety | |
| and effectiveness. | |
| Geometrical analysis demonstrates that the Arthrex Blunt Tip Screws are | |
| substantially equivalent to the Magna-FX Cannulated Screws. | |
| Based on the indication for use, technological characteristics, and the summary of | |
| data submitted, Arthrex, Inc. has determined that the Arthrex Blunt Tip Screws | |
| with FiberTape is substantially equivalent to currently marketed predicate | |
| devices |