ARTHREX HUMERAL FRACTURE PLATES AND SCREWS

K041965 · Arthrex, Inc. · HRS · Sep 8, 2004 · Orthopedic

Device Facts

• Record ID: K041965
• Device Name: ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
• Applicant: Arthrex, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Humeral Fracture Plates and Screws are intended to provide internal fixation for fractures of the humerus.

Device Story

Arthrex Humeral Fracture Plates and Screws are metallic bone fixation devices designed for the lateral proximal humerus. The system consists of spoon-shaped plates available in standard and long configurations, featuring spherical holes for angular screw locking and central holes for K-wire temporary fixation. Peripheral holes allow for soft tissue re-approximation using sutures like FiberWire. Screws are provided in cortical (3.5 mm) and cancellous (4.0 mm) designs. The device is used by surgeons in an operating room setting to stabilize humeral fractures. The surgeon selects the appropriate plate and screw configuration based on the fracture pattern, implants the hardware to provide rigid fixation, and uses the peripheral holes for soft tissue management. This fixation supports bone healing and restores structural integrity to the humerus.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation plates and screws. Materials include tissue-compatible metal. Features include spherical holes for angular locking, K-wire holes, and suture holes. Dimensions vary by configuration (standard/long plates; 3.5mm cortical/4.0mm cancellous screws). Non-sterile or sterile delivery (implied). Mechanical fixation principle.

Indications for Use

Indicated for internal fixation of humeral fractures in patients requiring surgical stabilization.

Regulatory Classification

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.

Predicate Devices

• Synthes Curved Reconstruction Plate (K011334)
• Synthes 3.5mm Broad LCP & 4.5mm CLP Distal Humerus Plate (K031178)
• Synthes 4.0mm Titanium Locking Screws (K032559)
• Synthes 2.7mm LC-DCP, 3.5mm Profile Plate (K011170)
• DePuy ACE TiMAX™ Meta Plate (K983853)

Submission Summary (Full Text)

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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.<br>1370 Creekside Boulevard<br>Naples, Florida 34108-1945 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust, RAC<br>Sr. Regulatory Affairs Specialist<br>Telephone: [phone] extension |
| | 1251 |
| | FAX: [phone] |
| TRADE NAME: | Arthrex Humeral Fracture Plates &<br>Screws |
| COMMON NAME: | Plate, fixation, bone<br>Screw, fixation, bone |
| CLASSIFICATION /<br>PRODUCT CODE | 21 CFR 888.3030 / HRS<br>Single/multiple component metallic bone<br>fixation appliances and accessories<br>21 CFR 888.3040 / HWC<br>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.

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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 [phone]. 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 [phone] or [phone] 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

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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 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|----|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>(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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