(5 days)
Not Found
No
The device description and intended use are purely mechanical in nature, describing plates and screws for bone fixation. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No.
The device is described as a system for internal bone fixation of fractures, fusions, or osteotomies, which is an orthopedic surgical device, not a therapeutic device.
No
Explanation: The device is a system of plates and screws for internal bone fixation, specifically for treating bone fractures, fusions, or osteotomies. Its intended use describes a therapeutic intervention rather than a diagnostic process.
No
The device description explicitly states it consists of "plates and screws," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist." This describes a surgical implant used to physically stabilize bone, not a test performed on biological samples to diagnose a condition.
- Device Description: The device consists of "plates and screws," which are physical components used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
The Arthrex Low Profile Plate and Screw System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Arthrex Low Profile Plate and Screw System consists of plates and screws. The plate is an L-shaped plate with four holes for insertion of screws for fixation. The plate is available in opening and closing wedge design, in various lengths, in both left and right configurations. The Arthrex screw is a cortical, headed, self-tapping screw available in one diameter, in numerous length options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, foot, hand, and wrist
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
SEP 2 8 2005
VIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Arthrex Low Profile Plate and Screw System
| NAME OF SPONSOR: | Arthrex, Inc.
1370 Creekside Boulevard
Naples, Florida 34108-1945 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust, RAC
Regulatory Affairs Project Manager
Telephone: (239) 643-5553 extension 1251
FAX: (239) 598-5539 |
| TRADE NAME: | Arthrex Low Profile Plate and Screw System |
| COMMON NAME: | Plate, fixation, bone
Screw, fixation, bone |
| CLASSIFICATION /
PRODUCT CODE | 21 CFR 888.3030 / HRS
Single/multiple component metallic bone fixation
appliances and accessories
21 CFR 888.3040 / HWC
Fastener, Fixation, Nondegradable, Soft Tissue
Smooth or threaded metallic bone fixation
fastener |
| PREDICATE DEVICES: | |
PREDICATE D
Arthrex Small Fragment Plates and Screws K040907
DEVICE DESCRIPTION AND INTENDED USE:
The Arthrex Low Profile Plate and Screw System consists of plates and screws. The plate is an L-shaped plate with four holes for insertion of screws for fixation. The plate is available in opening and closing wedge design, in various lengths, in both left and right configurations. The Arthrex screw is a cortical, headed, self-tapping screw available in one diameter, in numerous length options.
The Arthrex Low Profile Plate and Screw System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies for Hallux Valgus.
SUBSTANTIAL EQUIVALENCE SUMMARY
The Arthrex Low Profile Plate and Screw System is substantially equivalent to the predicate device where basic features and intended uses are the same. Any differences between the Low Profile Plate and Screw System and the predicate device are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the Low Profile Plate and Screw System is substantially equivalent to the currently marketed predicate device.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
SEP 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sally Foust, RAC Regulatory Affairs Project Manager Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K052614 Trade/Device Name: Arthrex Low Profile Plate and Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: September 21, 2005 Received: September 23, 2005
Dear Ms. Foust:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
2
Page 2 - Ms. Sally Foust, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millburn
Mark N. Melkerson Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE FORM III.
510(k) Number (if known):
Device Name: Arthrex Low Profile Plate and Screw System
Indications for Use:
The Arthrex Low Profile Plate and Screw System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.
Prescription Use __ × (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
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ence of CDRH, Office of In Vitro Evaluation (
Mark A. Milliron
(Division Sign-Off) (Division Sign of General, Restorative, Divisiourological Devices
510(k) Number K052614