(85 days)
Not Found
No
The device description and intended use are purely mechanical, describing plates and screws for bone fixation. There is no mention of any software, algorithms, or data processing that would suggest AI/ML.
No
The device is described as an internal bone fixation plate and screws, intended for structural support during bone healing, not for treating or preventing disease.
No
This device is an internal bone fixation system (plates and screws) used for treating bone fractures, fusions, or osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes physical hardware components (plates and screws) intended for surgical implantation. There is no mention of software as the primary or sole component.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Arthrex Small Fragment Plates and Screws are intended for internal bone fixation for fractures, fusions, or osteotomies. This is a surgical implant used directly within the body to stabilize bone.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic purpose.
Therefore, based on the provided information, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Arthrex Small Fragment Plates and Screws are 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Arthrex Small Fragment Plate is an L-shaped opening wedge 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.
K022325, K021626, K012655, K001941, K961497
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 01 2004
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Arthrex Small Fragment Plates and Screws
| NAME OF SPONSOR: | Arthrex, Inc.
1370 Creekside Boulevard
Naples, Florida 34108-1945 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust, RAC
Sr. Regulatory Affairs Specialist
Telephone: (239) 643-5553 extension 1251
FAX: (239) 598-5539 |
| TRADE NAME:
COMMON NAME: | Arthrex Small Fragment Plates and Screws
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:
- K022325 Normed Titanium Osteotomy Plating System, Osteomedics, Inc. K021626 Hallu Plates, NewDeal S.A. K012655 Congruent Bone Plate, Acumed, Inc. K001941 Modular Foot System, Synthes, (USA) K961497 Profyle® System, Howmedica, Inc.
DEVICE DESCRIPTION AND INTENDED USE:
The Arthrex Small Fragment Plate is an L-shaped opening wedge 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 Small Fragment Plates and Screws are 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 Valqus.
SUBSTANTIAL EQUIVALENCE SUMMARY
The Arthrex Small Fragment Plates and Screws are substantially equivalent to the predicate devices where basic features and intended uses are the same. Any differences between the Arthrex Small Fragment Plates and Screws and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the Small Fragment Plates and Screws are substantially equivalent to the currently marketed predicate devices.
Image /page/0/Picture/11 description: The image shows a series of zeros. The zeros are arranged in a row. The zeros are all the same size and shape. The zeros are all black.
1
Image /page/1/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized eagle with its wings spread. The eagle is composed of three curved lines that suggest movement and flight. The seal is black and white.
Public Health Service
JUL 01 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sally Foust, RAC Senior Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K040907
Trade/Device Name: Arthrex Small Fragment Plates and Screws Regulation Numbers: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HRS, HWC Dated: April 5, 2004 Received: April 7, 2004
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 - 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 (301) 594-4659. 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosurs
3
510(k) Number (if known): $040907
Device Name: Arthrex Small Fragment Plates and Screws
Indications (from labeling):
The Arthrex Small Fragment Plates and Screws are 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-CounterUse
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K040907
0000000