ARTHREX SMALL FRAGMENT PLATES AND SCREWS

K040907 · Arthrex, Inc. · HRS · Jul 1, 2004 · Orthopedic

Device Facts

• Record ID: K040907
• Device Name: ARTHREX SMALL FRAGMENT PLATES AND SCREWS
• Applicant: Arthrex, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Arthrex Small Fragment Plates and Screws are metallic bone fixation implants. The system consists of L-shaped opening wedge plates with four screw holes and cortical, headed, self-tapping screws. The device is used by surgeons for internal fixation of bone fractures, fusions, or osteotomies in the extremities (ankle, foot, hand, wrist). The plates provide structural support to stabilize bone segments during healing. The system is intended for clinical use in surgical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation plates and screws. Plates feature L-shaped opening/closing wedge designs with four holes. Screws are cortical, headed, and self-tapping. Materials are metallic (specific alloy not detailed).

Indications for Use

Indicated for internal bone fixation for fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, including opening wedge osteotomies for Hallux Valgus.

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

• Normed Titanium Osteotomy Plating System (K022325)
• Hallu Plates (K021626)
• Congruent Bone Plate (K012655)
• Modular Foot System (K001941)
• Profyle® System (K961497)

Submission Summary (Full Text)

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K040907

JUL 01 2004

## 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<br>FAX: [phone] |
| TRADE NAME:<br>COMMON NAME: | Arthrex Small Fragment Plates and Screws<br>Plate, fixation, bone<br>Screw, fixation, bone |
| CLASSIFICATION /<br>PRODUCT CODE | 21 CFR 888.3030 / HRS<br>Single/multiple component metallic bone fixation<br>appliances and accessories<br>21 CFR 888.3040 / HWC<br>Fastener, Fixation, Nondegradable, Soft Tissue<br>Smooth or threaded metallic bone fixation<br>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.

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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.

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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) 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 [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 Manufacturers, 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,

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

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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.

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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

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