LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,

K091294 · DePuy Orthopaedics, Inc. · HRS · Jul 24, 2009 · Orthopedic

Device Facts

• Record ID: K091294
• Device Name: LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jul 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The DePuy LCL 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

Metallic bone fixation system consisting of plates and accessories; used for stabilization and fixation of fractures, fusions, and osteotomies in various skeletal sites including hand, foot, and pelvis. Designed for use in both adult and pediatric (adolescent) populations, specifically avoiding open epiphyseal plates in skeletally immature patients. Operated by surgeons in clinical/surgical settings. Provides mechanical stabilization to bone segments to facilitate healing; particularly suited for osteopenic bone. Clinical benefit derived from structural support of bone during recovery.

Clinical Evidence

No clinical data provided; substantial equivalence supported by pre-clinical data.

Technological Characteristics

Metallic bone fixation system; design and materials are similar to currently marketed predicate devices. Class II device under 21 CFR 888.3030.

Indications for Use

Indicated for stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy), and non-unions of bones in hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula, and pelvis. Suitable for adult and pediatric patients (adolescents >12-21 years) provided implants do not cross open epiphyseal plates. Particularly indicated for 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.

Submission Summary (Full Text)

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K091294

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# SECTION 5-510(K) SUMMARY

DePuv Orthopaedics, Inc. JUL 2 4 2009 Submitted by: 700 Orthopaedic Drive Warsaw, IN 46581 Phone: [phone] [phone] Fax: Suzana Otaño, Project Manager, Regulatory Affairs Contact Person: April 30, 2009 Date Prepared: DePuy LCL and Fusion Plating System Proprietary Name: Common Name: Plate, Fixation, Bone Single/multiple component metallic bone fixation appliances Classification and accessories (21 CFR § 888.3030) Name: The DePuy LCL and Fusion Plating System is substantially Predicate Devices: equivalent to currently marketed devices. The DePuy LCL and Fusion Plating System is intended for use Intended 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. The technological characteristics of the DePuy LCL and Fusion Technological Characteristics: Plating System are similar to the predicate devices including design and material. The DePuy LCL and Fusion Plating System is substantially Summary of Substantial equivalent to currently marketed devices as demonstrated with pre-clinical data. No new issues of safety or efficacy have Equivalence: 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with outstretched wings. The symbol is stylized and composed of thick, curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Suzana Otaño 700 Orthopaedic Drive Warsaw, IN 46581-6386

JUL 2 4 2009

### Re: K091294

Trade/Device Name: DePuy LCL 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: July 2, 2009 Received: July 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.

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/cdrh/comp/ 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" (21CFR 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Barbare Buehup
for

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:

Device Name:

# DePuy LCL and Fusion Plating

KO91244

System

## Indications For Use:

The DePuy LCL 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)

Smita for mxn
(Division Sign Off)

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

510(k) Number K091294 Page 1 of 1

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

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