EXCIA

K061699 · Aesculap, Inc. · LWJ · Aug 18, 2006 · Orthopedic

Device Facts

• Record ID: K061699
• Device Name: EXCIA
• Applicant: Aesculap, Inc.
• Product Code: LWJ · Orthopedic
• Decision Date: Aug 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Excia Hip System is intended to replace a hip joint. The device is intended for: - Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. - Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral ephiphysis - Patients suffering from disability due to previous fusion - Patients with acute femoral neck fractures The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti. With a Ti. Plasma spray.

Device Story

Excia Total Hip System line extension; includes Plasmacup NSC and MSC acetabular cups. Components manufactured from titanium (Ti) with plasmapore coating; available in sizes 40mm-68mm. System includes femoral stems (CoCr for cemented; Ti with plasma spray for uncemented). Used by orthopedic surgeons in clinical settings for total hip arthroplasty. Device replaces diseased or damaged hip joint to alleviate pain and restore function. Surgeon selects appropriate cup design (no holes or multiple holes) and stem fixation method based on patient anatomy and bone quality. Output is a surgically implanted prosthetic hip joint.

Clinical Evidence

Bench testing only. Testing performed per FDA guidance documents for orthopedic implants, including metallic plasma-sprayed coatings, non-articulating modular components, acetabular cup prostheses, femoral stem prostheses, ceramic ball hip systems, and UHMWPE data requirements.

Technological Characteristics

Acetabular cups manufactured from titanium (Ti) with plasmapore coating. Femoral stems manufactured from CoCr (cemented) or Ti with Ti plasma spray (uncemented). Sizes 40mm-68mm. Modular design. Non-active, mechanical implant.

Indications for Use

Indicated for patients requiring hip joint replacement due to severe pain/disability from rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, femoral fracture nonunion, congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, previous fusion, or acute femoral neck fractures.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Excia Total Hip System (K042334)

Submission Summary (Full Text)

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Excia Toatal Hip System Line Extension

Special 510(k) Premarket Notification

.

AUG 1 8 2006

Page 1 of 1

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

Excia Total Hip System Line Extension June 13, 2006

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K061699

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 291671- |
|--------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle<br>610-984-9274 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | Excia |
| COMMON NAME: | Excia Total Hip System |
| DEVICE CLASS: | Class II |
| REGULATION NUMBER: | 888.3353, 888.3350, 888.3360 |
| PRODUCT CODE: | LZO, JDI, and LWJ |
| REVIEW PANEL: | Orthopedic |

## SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Acetabular Cups (Plasmacup® NSC and MSC) are substantially equivalent to the Acetabular Cups (Plasmacup® SC) that are cleared in the Excia Total Hip System (K042334).

## DEVICE DESCRIPTION

The Acetabular Cups (Plasmacup® NSC and MSC) are manufactured from Ti. and are offered with a plasmapore® coating. The Plasmacup® is offered in two designs: NSC and MSC (no holes or multiple holes). Both designs are available in sizes ranging from 40mm - 68mm. The new Plasmacup® Acetabular Cups are a line extension to the existing Excia Total Hip System.

## INDICATIONS FOR USE

The Excia Hip System is intended to replace a hip joint.

The device is intended for:

- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral . ephiphysis

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Special 510(k) Premarket Notification

- . Patients suffering from disability due to previous fusion
14061699

- Patients with acute femoral neck fractures �
The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti. With a Ti. Plasma spray,

#### TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s)}

The new Plasmacup® NSC and MSC acetabular cups of the Excia Total Hip System are offered in similar shapes and sizes as the predicate devices. The material used for the Aescualp device is the same as that used to manufacture the predicate device.

#### PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the;

- "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces . Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on . Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements",
- "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular . Implant Components",
- "Draft Guidance Document for Testing Acetabular Cup Prostheses", .
- "Points to Consider for Femoral Stem Prostheses", �
- "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball ◆ Hip Systems and
- "Data Requirements for Ultrahigh Molecular Weight Poletheylene (UHMWPE) Used . in Orthopedic Devices" was completed where applicable.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 8 2006

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

Re: K061699

Trade/Device Name: Excia Total Hip System Line Extension Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, JDI, LWJ Dated: July 25, 2006 Received: July 26, 2006

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

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Page 2 - Ms. Lisa M. Boyle

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. 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/industry/support/index.html.

Sincerely yours.

Kaitaque Spuchund

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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Special 510(k) Premarket Notification

Page 1 of 1

#### A. INDICATIONS FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

#### Device Name: Excia Total Hip System Line Extension

#### Indications for Use:

The Excia Hip System is intended to replace a hip joint.

The device is intended for:

- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral . ephiphysis
- Patients suffering from disability due to previous fusion ●
- Patients with acute femoral neck fractures .

The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti. With a Ti. Plasma spray.

| Prescription Use | X | and/or Over-the-Counter Use |
|----------------------------|---|-----------------------------|
| (per 21 CFR 801 Subpart D) | | (per 21 CFR 801 Subpart C) |

Barbara Bush

CONSE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Signeering DO NOT WRITE BELOW THIS LINE - CORPINGE ON ANTHER PAGE
Division of General, Restorative, and Neurological Devices

| 510(k) Number | K061999 |
|---------------|---------|
|---------------|---------|