ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM

K072832 · DePuy Orthopaedics, Inc. · HRS · Dec 14, 2007 · Orthopedic

Device Facts

• Record ID: K072832
• Device Name: ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Dec 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medial Locking Plate is indicated for: -Pilon Fractures: distal tibial intra-articular fractures -High medial malleolar fractures -Low boot type rotational distal extra-articular shaft fractures while the Anterolateral Locking Plate is indicated for: -Distal intra-articular tibia fractures -Proximal tibia fractures -Proximal and distal humerus fractures

Device Story

Anterolateral and Medial Locking Plating System consists of metallic bone plates and screws used for internal fixation of fractures. Device provides structural support to stabilize bone segments during healing. Used by orthopedic surgeons in clinical/surgical settings. Output is mechanical stabilization of bone fractures; facilitates bone healing and patient recovery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation plates and screws. Design and materials are identical to predicate devices. Class II device (21 CFR 888.3030).

Indications for Use

Indicated for patients with distal tibial intra-articular (Pilon) fractures, high medial malleolar fractures, low boot type rotational distal extra-articular shaft fractures, proximal tibia fractures, and proximal/distal humerus 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

• TiMax Medial Pilon Plate (K990120)
• TiMax Meta Plate (K983853)
• 3.5mm Cortical Bone Screws (K905048)
• Cancellous Bone Screws (K882381)

Submission Summary (Full Text)

{0}------------------------------------------------

# K072832 (pg 1/1)

.

## Section 5 - 510(k) Summary

DEC 1 4 2007

| Submitted by: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581<br>Phone: [phone]<br>Fax: [phone] | | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------------|
| Contact Person: | Suzana Otaño, Sr. Regulatory Affairs Associate | | |
| Date Prepared: | October 2, 2007 | | |
| Proprietary Name: | Anterolateral and Medial 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: | DePuy | K990120 | TiMax Medial Pilon Plate |
| | DePuy | K983853 | TiMax Meta Plate |
| | DePuy | K905048 | 3.5mm Cortical Bone<br>Screws |
| | DePuy | K882381 | Cancellous Bone Screws |
| Intended Use: | The Medial Locking Plate is indicated for:<br>-Pilon Fractures: distal tibial intra-articular fractures<br>-High medial malleolar fractures<br>-Low boot type rotational distal extra-articular shaft fractures<br><br>while the Anterolateral Locking Plate is indicated for:<br>-Distal intra-articular tibia fractures<br>-Proximal tibia fractures<br>-Proximal and distal humerus fractures | | |
| Technological<br>Characteristics: | The technological characteristics of the Anterolateral and<br>Medial Locking Plating System are the same as the predicate<br>device including design and material. | | |
| Summary of<br>Substantial<br>Equivalence: | The Anterolateral and Medial Locking Plating System is<br>substantially equivalent to the currently marketed DePuy<br>devices. No new issues of safety or efficacy have been raised. | | |

:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{1}------------------------------------------------

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 the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a triple-lined design resembling an abstract caduceus or a stylized representation of human figures, symbolizing health and well-being.

DEC 1 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy % Ms. Suzana Otaño Sr. Regulatory Affairs Associate 700 Orthopaedics Drive Warsaw, IN 46581

Re: K072832

Trade/Device Name: Anterolateral and Medial Locking 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: October 2, 2007 Received: October 3, 2007

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.

{2}------------------------------------------------

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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Mulhausen

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

Enclosure

{3}------------------------------------------------

K072832 (pg 1/1)

### SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number:

### Anterolateral and Medial Locking Device Name: Plating System

Indications For Use:

The Medial Locking Plate is indicated for: -Pilon Fractures: distal tibial intra-articular fractures -High medial malleolar fractures -Low boot type rotational distal extra-articular shaft fractures

while the Anterolateral Locking Plate is indicated for:

-Distal intra-articular tibia fractures

-Proximal tibia fractures

-Proximal and distal humerus fractures

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) |
|--------------------------------------------------------|
|--------------------------------------------------------|

Mark A. Miller

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

510(k) Number