2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424

K083364 · DePuy Orthopaedics, Inc. · HRS · Dec 11, 2008 · Orthopedic

Device Facts

• Record ID: K083364
• Device Name: 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Dec 11, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Small Bone Locking Plating System Line Extension is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

Device Story

Small Bone Locking Plating System Line Extension; metallic bone fixation appliance. Combines traditional compressive plating with locking screw and multidirectional locking screw technology. Used by surgeons for stabilization/fixation of small bone fractures, revisions, joint fusions, and reconstructions. Benefits include enhanced fixation in osteopenic bone. Device is purely mechanical; no software or electronic components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation appliance; locking and multidirectional locking screw technology; compressive plating system. No software or electronic components.

Indications for Use

Indicated for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones (hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, craniomaxillofacial skeleton), 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

• DePuy Small Bone Locking Plating System (K081546)

Submission Summary (Full Text)

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# V083364

# DEC 1 1 2008

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### 510(k) Summary

| Submitted by: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581<br>Phone: [phone]<br>Fax: [phone] | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs | |
| Date Prepared: | November 12, 2008 | |
| General<br>Provisions | The name of the device is: | |
| | Proprietary Name | Common or Usual Name |
| | Small Bone Locking Plating<br>System | Plate, Fixation, Bone |
| Name of<br>Predicate<br>Devices | The device is substantially equivalent to the currently marketed DePuy<br>Small Bone Locking Plating System, K081546. | |
| Classification | Class II, 21 CFR 888.3030 | |
| Performance<br>Standards | Performance standards have not be en established by the FDA under<br>section 514 of the Food, Drug and Cosmetic Act for these devices. | |
| Indications for<br>Use | The Small Bone Locking Plating System Line Extension is intended for<br>stabilization and fixation of small bone fragments in fresh fractures,<br>revision procedures, joint fusion and reconstructions of small bones of the<br>hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and<br>craniomaxillofacial skeleton, particularly in osteopenic bone. | |
| Device<br>Description | The Small Bone Locking Plating System Line Extension combines the<br>attributes of a traditional compressive plating system with the enhanced<br>benefits of locking screw and multidirectional locking screw technology. | |
| Biocompatibility | The Small Bone Locking Plating System Line Extension does not require<br>biocompatibility testing. | |
| Summary of<br>Substantial<br>Equivalence | The Small Bone Locking Plating System Line Extension is substantially<br>equivalent to the predicate devi ce. Equivalence was confirmed through<br>bench testing. | |

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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 or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Suzana Otaño 700 Orthopaedic Drive Warsaw, IN 46581-0988

# DEC 1 1 2008

Re: K083364

Trade/Device Name: DePuy Small Bone Locking Plating System Line Extension 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: November 12, 2008 Received: November 13, 2008

Dear Ms. Otaño:

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. 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 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.

Mark M. Millican

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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510(k) Number:

## Device Name:

# DePuy Small Bone Locking Plating System Line Extension

#### Indications For Use:

The DePuy Small Bone Locking Plating System Line Extension is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

K083364

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)

Nikroghde Lofmxm

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K083364

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DePuy Small Bone Locking Plating System Line Extension Special 510(k)