SMALL FRAGMENT LOCKING PLATING SYSTEM

K072083 · DePuy Orthopaedics, Inc. · HRS · Oct 25, 2007 · Orthopedic

Device Facts

• Record ID: K072083
• Device Name: SMALL FRAGMENT LOCKING PLATING SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Oct 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Small Fragment Locking Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

Device Story

Small Fragment Locking Plating System consists of metallic bone plates and screws used for internal fixation of fractures, osteotomies, and non-unions. Device is intended for use in various anatomical sites including clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula. It is specifically indicated for use in osteopenic bone. Device is used by orthopedic surgeons in a clinical or surgical setting to stabilize bone segments, facilitating healing. Operation involves standard surgical techniques for plate and screw fixation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Metallic bone fixation system. Design and materials are identical to predicate devices. Class II device under 21 CFR 888.3030.

Indications for Use

Indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in patients with osteopenic bone.

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

• Small Fragment Dynamic Compression Locking (DCL) System (K000684)
• Cancellous Bone Screws (K882831)
• 3.5mm Cortical Bone Screws (K905048)

Submission Summary (Full Text)

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K072083 (pg. 1 of 1)

# Section 5 — 510(k) Summary

| Submitted by: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581<br>Phone: [phone]<br>Fax: [phone] | | | OCT 25 2007 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------------------------|-------------|
| Contact Person: | Suzana Otaño, Sr. Regulatory Affairs Associate | | | |
| Date Prepared: | July 27, 2007 | | | |
| Proprietary Name: | Small Fragment Locking Plating System | | | |
| Common Name: | Plate, Fixation, Bone | | | |
| Classification<br>Name: | Single/multiple component metallic bone fixation appliances<br>and accessories (21 CFR § 888.3030) | | | |
| Predicate Devices: | Synthes | K000684 | Small Fragment Dynamic<br>Compression Locking (DCL)<br>System | |
| | DePuy ACE | K882831 | Cancellous Bone Screws | |
| | DePuy ACE | K905048 | 3.5mm Cortical Bone<br>Screws | |
| Intended Use: | The Small Fragment Locking Plating System is intended for<br>fixation of fractures, osteotomies and non-unions of the<br>clavicle, scapula, olecranon, humerus, radius, ulna, pelvis,<br>distal tibia, fibula, particularly in osteopenic bone. | | | |
| Technological<br>Characteristics: | The technological characteristics of the Small Fragment<br>Locking Plating System are the same as the predicate devices<br>including design and material. | | | |
| Summary of<br>Substantial<br>Equivalence: | The Small Fragment Locking Plating System is substantially<br>equivalent to the currently marketed Synthes and DePuy<br>devices. No new issues of safety or efficacy have been raised. | | | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three tails, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DuPuv Orthopaedics, Inc. % Ms. Suzana Otaño Sr. Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, IN 46582

> K072083 Trade/Device Name: Small Fragment Locking Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 27, 2007 Received: July 30, 2007

Dear Ms. Otaño:

Re:

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.

OCT 2 5 2007

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. Suzana Otaño

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Rarbara Bucher

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

Enclosure

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# SECTION 4 - INDICATIONS FOR USE STATEMENT

#### K072083 510(k) Number:

## Small Fragment Locking Plating Device Name: System

Indications For Use: The Small Fragment Locking Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

vbere melmo

Division of General, Restorative, and Neurological Devices

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510(k) Number K072083

Small Fragment Locking Plating System Traditional 510(k) DePuy Orthopaedics, Inc.

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