POLYAX LOCKED PLATING SYSTEM

K060969 · DePuy Orthopaedics, Inc. · HRS · May 12, 2006 · Orthopedic

Device Facts

• Record ID: K060969
• Device Name: POLYAX LOCKED PLATING SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: May 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy POLYAX Locked Plating System is intended to be implanted for the fixation of bone fractures and osteotomies, implanted either percutaneously or by a tre divinoval open method.

Device Story

The POLYAX Locked Plating System consists of anatomically contoured, multi-hole metallic bone plates and screws. The system provides surgeons with polyaxial, fixed-angle, variable-angle, and non-locking construct options for bone fixation. Used in orthopedic surgery, the device is implanted via percutaneous or open surgical methods to stabilize fractures, malunions, non-unions, and osteotomies of the distal femur and proximal tibia. By providing rigid internal fixation, the system supports bone healing and restores structural integrity to the affected limb, benefiting patients by facilitating stabilization of complex periarticular and periprosthetic fractures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarity to legally marketed predicate devices.

Technological Characteristics

System comprises metallic bone plates and screws. Features polyaxial, fixed-angle, variable-angle, and non-locking screw mechanisms. Designed for distal femur and proximal tibia fixation. Class II device per 21 CFR 888.3030.

Indications for Use

Indicated for stabilization of malunions, non-unions, and osteotomies of the distal femur and proximal tibia, and ORIF repair of closed and open fractures of the distal femur and proximal tibia, including periarticular, simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression with shaft fractures, and periprosthetic fractures.

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 POLYAX Knee Fracture System (K003235)
• Zimmer Periarticular Locking Plates (K040593)

Submission Summary (Full Text)

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MAY 1 9 2005

K060969
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# 510 (k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93)

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Establishment Registration Number: 1818910 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer<br>Regulatory Affairs<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | March 29, 2006 |
| PROPRIETARY NAME: | POLYAX™ Locked Plating System |
| COMMON NAME: | Bone Fixation Device |
| CLASSIFICATION: | Class II device per 21 CFR 888.3030:<br>Single/Multiple component metallic bone fixation<br>appliances and accessories |
| DEVICE PRODUCT CODE: | 87 HRS |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | DePuy POLYAX Knee Fracture System,<br>K003235, cleared on November 6, 2000<br>Zimmer Periarticular Locking Plates,<br>K040593, cleared on April 12, 2004 |

## DEVICE DESCRIPTION:

The DePuy POLYAX Locked Plating System is comprised of anatomically contoured, multi-hole fracture plates and screws. The plates allow for polyaxial screw locking, with, provisions for fixed angle locking, variable angle locking and non-locking, vriw construct options.

# INTENDED USE AND INDICATIONS:

#### Intended Use:

The DePuy POLYAX Locked Plating System is intended to be implanted for the fixation of bone fractures and osteotomies, implanted either percutaneously or by a tre divinoval open method.

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#### Indications for Use:

The POLYAXTM Locked Plating System is intended for use in cases requiring stabilization of malunions, non-unions, and osteotomies of the distal femur and proximal tibia and Open Reduction Internal Fixation (ORIF) repair of closed and open fractures of the distal femur and proximal tibia including, but not limited to the following: periarticular fractures, such as simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression fractures with associated shaft fractures, and periprosthetic fractures.

### BASIS OF SUBSTANTIAL EQUIVALENCE:

The substantial equivalence of the DePuy POLYAX Locked Plating System is substantiated by its similarity in intended use, indications for use, materials and design to the existing DePuy POLYAX Knee Fracture System, K003235, cleared on November 6, 2000, and to Zimmer Periarticular Locking Plates, K040593, cleared on April 12, 2004

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent coiled around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2006

DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K060969

Trade/Device Name: POLYAX™ Locked 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 Dated: April 5, 2006 Received: April 7, 2006

Dear Ms. Myer:

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

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### Page 2 - Ms. Rhonda Myer

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. 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.

Sincerely, yours,

C.M.

· 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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Image /page/4/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo features a large, bold, sans-serif font for the name "DePuy", with a solid black circle to the left of the name. Below the name is a thin, horizontal line, and beneath that line is the text "a Johnson & Johnson company" in a smaller, serif font.

DePuy Orihopaedics, Inc.

PD Sox 388 700 Orthopaedic Drive 14 toons 16581-0988 ಿಗೆ

Tel: [phone]

## Indications for Use Statement

K660969 510 (k) Number (if known):

Device Name:

Indications for Use:

The POLYAXTM Locked Plating System is intended for use in cases requiring stabilization of malunions, non-unions, and osteotomies of the distal femur and proximal tibia and Open Reduction Internal Fixation (ORIF) repair of closed and open fractures of the distal femur and proximal tibia including, but not limited to the following: periarticular fractures, such as simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression fractures with associated shaft fractures, and periprosthetic fractures.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ×

Over-The-Counter-Use: OR

(Please do not write below this line - continue on another page if nexessary)

Q. Malle

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

510(k) Numbe KO60969