ARTHREX HUMERAL FRACTURE PLATES AND SCREWS by ARTHREX, INC.

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.

AI/ML Overview

This 510(k) premarket notification for the Arthrex Small Fragment Plates and Screws (specifically the Arthrex Humeral Fracture Plates & Screws) is focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance from a clinical study.

Therefore, the input document does not contain the information requested regarding acceptance criteria, device performance, study details, expert involvement, or ground truth establishment for a device study.

The document is a 510(k) summary, which typically focuses on:

Identification of the device: Trade name, common name, classification, product code.
Sponsor information.
Predicate devices: Listing similar, legally marketed devices to which substantial equivalence is being claimed.
Device description: How the device works and its features.
Intended use/indications for use.
Statement of substantial equivalence.
FDA's response letter: Confirmation of substantial equivalence.

Without a clinical study or performance data presented in the provided text, I cannot fill in the requested table or answer the specific questions about acceptance criteria, study design, or results.

Summary of missing information:

Acceptance criteria and reported device performance: Not present. The document focuses on substantial equivalence to existing devices, not new performance metrics against specific criteria.
Sample size and data provenance: No study data is provided.
Number and qualifications of experts for ground truth: Not applicable as no study is detailed.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not mentioned or applicable here.
Standalone (algorithm only) performance: Not applicable as this is a medical device (plate and screws), not an algorithm.
Type of ground truth: Not applicable.
Sample size for training set: Not applicable.
How ground truth for training set was established: Not applicable.

Summary

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SEP = 8 2004

K041965
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Arthrex Small Fragment Plates and Screws

NAME OF SPONSOR:	Arthrex, Inc.1370 Creekside BoulevardNaples, Florida 34108-1945
510(K) CONTACT:	Sally Foust, RACSr. Regulatory Affairs SpecialistTelephone: (239) 643-5553 extension
	1251
	FAX: (239) 598-5539
TRADE NAME:	Arthrex Humeral Fracture Plates &Screws
COMMON NAME:	Plate, fixation, boneScrew, fixation, bone
CLASSIFICATION /PRODUCT CODE	21 CFR 888.3030 / HRSSingle/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040 / HWCFastener, 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:

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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.

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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,

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

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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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Regulation Number and Section

§ 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.