AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM

K080992 · Aesculap Implant Systems, Inc. · HRS · Sep 4, 2008 · Orthopedic

Device Facts

• Record ID: K080992
• Device Name: AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
• Applicant: Aesculap Implant Systems, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.

Device Story

The HTO Plating System is a metallic bone fixation device used by orthopedic surgeons in a clinical/surgical setting. It consists of a tapered plate, spacer blocks, and cancellous/cortical bone screws. The system provides mechanical stabilization of the tibia following an opening wedge osteotomy procedure. The surgeon implants the device to maintain bone alignment during the healing process, facilitating bone union. The device is provided sterile.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: Titanium/Titanium Alloy. Components: Tapered plate, spacer blocks, 6 mm cancellous screws, 4.5 mm cortical screws. Sterilization: Provided sterile. Mechanical fixation principle.

Indications for Use

Indicated for patients undergoing proximal tibial opening wedge osteotomies requiring bone fixation.

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

• Arthrex Puddu Osteotomy System (K973812)

Submission Summary (Full Text)

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

KOS0992

### SEP - 4 2008

Page 1 of 1

#### 510(k) SUMMARY (as required by 21 CFR 807.92)

#### High Tibial Osteotomy (HTO) Plating System April 7, 2008

| COMPANY: | Aesculap Implant Systems, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle<br>[phone] (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | HTO Plating System |
| COMMON NAME: | High Tibial Osteotomy (HTO) Plating System |
| CLASSIFICATION NAME: | Plate, Fixation, Bone (HRS)<br>Screw, Fixation, Bone (HWC) |

# SUBSTANTIAL EQUIVALENCE

REGULATION NUMBER: 888.3030 / 888.3040

Aesculap Implant Systems, Inc., believes that the HTO Plating System is substantially equivalent to the Arthrex Puddu Osteotomy System (K973812).

#### DEVICE DESCRIPTION

The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System which consists of a single tapered plate, screws (cancellous and cortical design), and spacer blocks in various sizes. The plate in this system accepts 6 mm cancellous screws proximally and 4.5 mm cortical screw distally. The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is manufactured from Titanium/Titanium Alloy and will be provided sterile.

#### INDICATIONS FOR USE

The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.

## TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The Aesculap Implant Systems HTO Plating System is considered substantially equivalent to other legally marketed predicate systems. Biomechanical testing of the subject device was found to be similar in performance to previously cleared high tibial osteotomy systems with similar indications.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap Implant Systems, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

SEP - 4 2008

Re: K080992

Trade/Device Name: High Tibial Osteotomy (HTO) 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: August 5, 2008 Received: August 5, 2008

Dear Ms. Boyle:

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. Lisa M. Boyle

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 N Millman

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

Enclosure

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

Page 1 of 1

#### A. INDICATIONS FOR USE STATEMENT

Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating Device Name:

System

------

#### Indications for Use:

The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(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)

Barbara Brelund for npm

(Division of General, Restorative, and Neurological Devices

**510(k) Number**
K083094