(28 days)
Not Found
No
The device description and intended use are for standard bone screws, and there is no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics associated with AI/ML.
Yes
The screws are intended for internal bone fixation for fractures, fusions, osteotomies, and non-unions, which are therapeutic interventions.
No.
The device is described as screws for internal bone fixation of fractures, fusions, osteotomies, and non-unions, which are therapeutic and restorative functions, not diagnostic.
No
The device description explicitly states the device is made of titanium or stainless steel screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes the Arthrex Low Profile Screws as implants used for internal bone fixation in various parts of the body. They are physical devices used to stabilize bones, not to analyze biological samples.
The information provided aligns with a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Low Profile Screws (2.0-3.0mm 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 and Small Fragment Plates.
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) 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, and wrist.
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 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 and Small Fragment 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 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.
Product codes
HWC, HRS
Device Description
The Arthrex Low Profile Screws are titanium or stainless steel, fully or partially threaded, solid or cannulated, self-tapping, headed screws. The screws range from 2.0mm to 4.0mm in diameter and in length from 8mm to 80mm.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract image of a bird-like figure, composed of three human profiles facing to the right.
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: K143614
Trade/Device Name: Arthrex Low Profile Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: December 22, 2014 Received: December 23, 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 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
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Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
2.5 INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Arthrex Low Profile Screws
Indications for Use (Describe)
The Arthrex Low Profile Screws (2.0-3.0mm 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 and Small Fragment Plates.
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) 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, and wrist.
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 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 and Small Fragment 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 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.
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)
FORM FDA 3881 (9/13)
PSC Publishing Services (301) 443-6
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| 2.6 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | |
|---|---|
| Date Summary Prepared | October 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 Low Profile Screws |
| Common Name | Screw, fixation, bone |
| Product Code -Classification Name | HWC - Screw, Fixation, Bone |
| HRS - Plate, 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 | 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 Low Profile Screws | |
| which were cleared as non-sterile devices through K103705. | |
| This special 510(k) premarket notification is also intended to | |
| address the addition of 3.75mm Low Profile Screws and Low | |
| Profile Variable Angle Locking Screws as line extensions to the | |
| cleared predicate, which are similar in design and identical in | |
| material and intended use. | |
| Device Description | The Arthrex Low Profile Screws are titanium or stainless steel, |
| fully or partially threaded, solid or cannulated, self-tapping, | |
| headed screws. The screws range from 2.0mm to 4.0mm in | |
| diameter and in length from 8mm to 80mm. | |
| Intended Use | The Arthrex Low Profile Screws (2.0-3.0mm 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, and | |
| wrist. When used with a plate, the screw may be used with the | |
| Arthrex Low Profile and Small Fragment Plates. | |
| The Arthrex Low Profile Screws (2.0-3.0mm cannulated) 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, and wrist. | |
| 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 and Small | |
| Fragment 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 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. | |
| Substantial Equivalence Summary | The Arthrex Low Profile 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 Low Profile Screws and the predicates are considered | |
| minor and do not raise questions concerning safety and | |
| effectiveness. | |
| The predicate screws are non-sterile. The proposed plates and | |
| screws will undergo Gamma Irradiation or Ethylene Oxide (EO) | |
| sterilization. | |
| The new 3.75mm Low Profile Screws and Low Profile Variable | |
| Angle Locking Screws are within the cleared size range of | |
| predicate K103705. | |
| Based on the indications for use, technological characteristics, | |
| and the summary of data submitted, Arthrex, Inc. has | |
| determined that the Arthrex Low Profile Screws are | |
| substantially equivalent to the predicates. |
2.6 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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