DEPUY FRACTURE AND FUSION PLATING SYSTEM

K093474 · DePuy Orthopaedics, Inc. · HRS · Feb 2, 2010 · Orthopedic

Device Facts

• Record ID: K093474
• Device Name: DEPUY FRACTURE AND FUSION PLATING SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Feb 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The DePuy Fracture and Fusion Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Device Story

The DePuy Fracture and Fusion Plating System consists of metallic bone fixation plates and accessories; used for stabilization and fixation of fractures, fusions, and osteotomies in various skeletal sites including extremities and pelvis. Designed for use in osteopenic bone; implanted by surgeons in clinical settings. Device provides mechanical support to bone segments to facilitate healing; does not involve electronic inputs, software, or algorithms. Benefit derived from structural stabilization of bone segments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation system; components include plates and accessories. Design and materials are similar to existing predicate devices. No electronic components, software, or energy sources.

Indications for Use

Indicated for stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy), and non-unions of bones in the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula, and pelvis. Suitable for adult and pediatric patients (adolescents >12-21 years). Contraindicated for use crossing open epiphyseal plates in skeletally immature patients.

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.

Submission Summary (Full Text)

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K093474 #1/1.

# SECTION 5-510(K) SUMMARY

FEB - 2 2010 Submitted by: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581 Phone: [phone] Fax: [phone]

Contact Person: Suzana Otaño, Project Manager, Regulatory Affairs

November 4, 2009 Date Prepared:

DePuv Fracture and Fusion Plating System Proprietary Name:

Common Name: Plate, Fixation, Bone

Classification Single/multiple component metallic bone fixation appliances Name: and accessories (21 CFR § 888.3030)

The DePuy Fracture and Fusion Plating System is substantially Predicate Devices: equivalent to currently marketed devices.

Intended Use:

The DePuy Fracture and Fusion Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and nonunions of the bones of the hand, foot, wrist, ankle, finger, toe. humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [> 12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

- The technological characteristics of the DePuv Fracture and Technological Characteristics: Fusion Plating System are similar to the predicate devices including design and material.
Summarv of The DePuv Fracture and Fusion Plating System is substantially Substantial equivalent to currently marketed devices as demonstrated with Equivalence: pre-clinical data. 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle or bird-like figure with outstretched wings. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581

FEB - 2 2010

Re: K093474

Trade/Device Name: DePuy Fracture and Fusion Plating 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: November 4, 2009 Received: November 6, 2009

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

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## SECTION 4 - INDICATIONS FOR USE STATEMENT

**510(k) Number:** K093474

DePuy Fracture and Fusion Device Name: Plating System

## Indications For Use:

The DePuy Fracture and Fusion Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

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)

Oputa for mxn

(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093474

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Fracture and Fusion Plating System Traditional 510(k) DePuy Orthopaedics, Inc.

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