LOW PROFILE PLATE AND SCREW SYSTEM

K052614 · Arthrex, Inc. · HRS · Sep 28, 2005 · Orthopedic

Device Facts

• Record ID: K052614
• Device Name: LOW PROFILE PLATE AND SCREW SYSTEM
• Applicant: Arthrex, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 28, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Low Profile Plate and Screw System is 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 of Hallux Valgus.

Device Story

System consists of L-shaped metallic plates and cortical, headed, self-tapping screws. Plates feature four holes for screw insertion; available in opening and closing wedge designs, various lengths, and left/right configurations. Screws available in one diameter with multiple length options. Used by surgeons for internal bone fixation during orthopedic procedures in extremities (ankle, foot, hand, wrist). Provides mechanical stabilization of bone segments to facilitate healing of fractures, fusions, or osteotomies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation system. Components include L-shaped plates and cortical, headed, self-tapping screws. Mechanical fixation principle. Non-degradable. No software or electronic components.

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

• Arthrex Small Fragment Plates and Screws (K040907)

Submission Summary (Full Text)

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K052614

SEP 2 8 2005

# VIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Arthrex Low Profile Plate and Screw System

| NAME OF SPONSOR: | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, Florida 34108-1945 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust, RAC<br>Regulatory Affairs Project Manager<br>Telephone: [phone] extension 1251<br>FAX: [phone] |
| TRADE NAME: | Arthrex Low Profile Plate and Screw System |
| COMMON NAME: | 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: | |

## PREDICATE D

Arthrex Small Fragment Plates and Screws K040907

### DEVICE DESCRIPTION AND INTENDED USE:

The Arthrex Low Profile Plate and Screw System consists of plates and screws. The plate is an L-shaped 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 Low Profile Plate and Screw System is 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.

#### SUBSTANTIAL EQUIVALENCE SUMMARY

The Arthrex Low Profile Plate and Screw System is substantially equivalent to the predicate device where basic features and intended uses are the same. Any differences between the Low Profile Plate and Screw System and the predicate device are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the Low Profile Plate and Screw System is substantially equivalent to the currently marketed predicate device.

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SEP 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sally Foust, RAC Regulatory Affairs Project Manager Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K052614 Trade/Device Name: Arthrex Low Profile Plate and Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: September 21, 2005 Received: September 23, 2005

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 - Ms. 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,
Mark A. Millburn

Mark N. Melkerson Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE FORM III.

510(k) Number (if known):

## Device Name: Arthrex Low Profile Plate and Screw System

## Indications for Use:

The Arthrex Low Profile Plate and Screw System is 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 of Hallux Valgus.

Prescription Use __ × (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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ence of CDRH, Office of In Vitro Evaluation (

Mark A. Milliron

(Division Sign-Off) (Division Sign of General, Restorative, Divisiourological Devices

510(k) Number K052614