(49 days)
Not Found
No
The device description focuses on the mechanical design and materials of the plates and screws for fracture fixation, with no mention of AI or ML capabilities.
No
The device provides internal fixation for fractures, which is a structural repair, not a therapeutic treatment aimed at restoring health through non-surgical means or addressing disease.
No
The device is described as a plate and screws used for internal fixation of humerus fractures, which is a therapeutic purpose, not a diagnostic one.
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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Arthrex Humeral Fracture Plates and Screws are implants used for the internal fixation of bone fractures. They are physically placed inside the body to stabilize broken bones.
- Intended Use: The intended use is to "provide internal fixation of fractures of the humerus," which is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The information provided describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Arthrex Humeral Fracture Plates and Screws are intended to provide internal fixation of fractures of the humerus.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Arthrex Humeral Fracture Plate is designed as a spoon shaped plate to The Anthrox fiamonee lateral proximal aspect of the humerus. The plate is available in two size configurations, standard and long. Spherical holes with available in the for angular locking of the screws in the plate. Smaller holes in the center of the plate allow for temporary fixation during surgery with K-wires. Peripheral holes allow re-approximation of soft tissue with suture, such as FiberWire®. The screws are available in various lengths in two design options, cortical and cancellous. The cortical screws are 3.5 mm in diameter and the cancellous screws are 4.0 mm in diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus
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.
K011334, K031178, K032559, K011170, K983853
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 = 8 2004
K041965
page 1 of 1
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: | Arthrex Humeral Fracture Plates &
Screws |
| 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 |
PREDICATE DEVICES:
K011334 Synthes Curved Reconstruction Plate K031178 Synthes 3.5mm Broad LCP & 4.5mm CLP Distal Humerus Plate K032559 Synthes 4.0mm Titanium Locking Screws K011170 Synthes 2.7mm LC-DCP, 3.5mm Profile Plate K983853 DePuy ACE TiMAX™ Meta Plate
Tissue Smooth or threaded metallic
bone fixation fastener
DEVICE DESCRIPTION AND INTENDED USE:
The Arthrex Humeral Fracture Plate is designed as a spoon shaped plate to The Anthrox fiamonee lateral proximal aspect of the humerus. The plate is available in two size configurations, standard and long. Spherical holes with available in the for angular locking of the screws in the plate. Smaller holes in the center of the plate allow for temporary fixation during surgery with K-wires. Peripheral holes allow re-approximation of soft tissue with suture, such as FiberWire®. The screws are available in various lengths in two design options, cortical and cancellous. The cortical screws are 3.5 mm in diameter and the cancellous screws are 4.0 mm in diameter.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 8 2004
Sally Foust, RAC Senior Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K041965
Trade/Device Name: Arthrex Humeral Fracture Plates and Screws Regulation Numbers: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS, HWC Dated: July 17, 2004 Received: July 21, 2004
Dear Ms. Foust:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the encrea, 1976, the enactment date of the Medical Device Amendments, or to conniner of the rial) 2011-11-11 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 r ou mayy attribute 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to been week 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 r louse of acreation that i Dr. Mat your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny i vith 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) I ins letter will anow you to FDA finding of substantial equivalence of your device to a legally premated predicated 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 If you desire 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 other general 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,
Sincerely yours,
L. Mark A. Millam
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
Enclosure
3
510(k) Number (if known): K041965
Device Name: Arthrex Humeral Fracture Plates and Screws
Indications (from labeling):
The Arthrex Humeral Fracture Plates and Screws are intended to provide internal The Anthrox Humal fractures of the humerus.
| Prescription Use | く | OR |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
| (Per 21 CFR 801.109) |
Over-The-CounterUse __
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ---------------------------------------
nce of CDRH, Office of Device Evaluation (ODE)
Mark N. Matheson
Divist and
510(k) Number K041965
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