EXCIA TOTAL HIP SYSTEM WITH U-CAP

K060437 · Aesculap, Inc. · MEH · Mar 22, 2006 · Orthopedic

Device Facts

• Record ID: K060437
• Device Name: EXCIA TOTAL HIP SYSTEM WITH U-CAP
• Applicant: Aesculap, Inc.
• Product Code: MEH · Orthopedic
• Decision Date: Mar 22, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• 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 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 . epiphysis - Patients suffering from disability due previous fusion . - Patients with acute femoral neck fractures . The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without u CaP®.

Device Story

Total hip replacement system; includes femoral stems, acetabular cups (Plasmacup), acetabular inserts, and femoral heads. Two femoral stem options: CoCrMo for cemented fixation; Ti with Plasmapore coating (with/without µ-CaP) for uncemented fixation. Acetabular cups are Ti with Plasmapore (with/without µ-CaP); inserts are UHMWPE. PMMA distal centralizers used for stem alignment. Used by orthopedic surgeons in clinical settings to restore hip joint function; provides structural replacement for diseased or damaged hip joints; improves patient mobility and reduces pain.

Clinical Evidence

Bench testing only. Testing performed per FDA guidance for orthopedic devices, including evaluations of metallic plasma-sprayed coatings, non-articulating modular components, femoral stem prostheses, and calcium phosphate coatings.

Technological Characteristics

Materials: CoCrMo, Ti, UHMWPE, PMMA. Coatings: Plasmapore (plasma spray), µ-CaP (calcium phosphate). Components: Femoral stems (cemented/uncemented), acetabular cups, acetabular inserts (symmetrical/asymmetrical), femoral heads. Fixation: Cemented or uncemented. Distal centralizers for alignment.

Indications for Use

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

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Excia Total Hip System (K042344)
• BiContact Hip System with u-CaP (K043079)
• Trident Acetabular Shells: PS-HA (K001448)

Submission Summary (Full Text)

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

Kobo437

Page 1 of 2

MAR 2 2, 2006

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

# EXCIA TOTAL HIP SYSTEM with u-CAP®

February 20, 2006

| COMPANY: | Aesculap ® , Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky, Regulatory Affairs Associate<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>kathy.racosky @ aesculap.com (email) |
| TRADE NAME: | Excia |
| COMMON NAME: | Excia Total Hip System with $ \mu $ -CaP® |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 87MEH |
| CLASSIFICATION: | 888.3353 |
| REVIEW PANEL: | Orthopedic |

## INTENDED USE

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

The device is intended for:

- Patients suffering from severe hip 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 . epiphysis
- Patients suffering from disability due previous fusion .
- Patients with acute femoral neck fractures .

The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without u CaP®.

#### DEVICE DESCRIPTION

The Excia Total Hip System is available with two femoral designs. One is manufactured from Ti with a plasma spray coating (Plasmapore) with or with out u-CaP®. This component is intended for uncemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. Distal centralizers maintain the stem's alignment in the femoral canal. The centralizers are manufactured from PMMA.

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

Page 2 of 2

The acetabular cup (Plasmacup) is manufactured from Ti and is coated with Plasmapore with or without u-CaP® as well. Acetabular cup screws can be used for further cup fixation. The acetabular inserts are UHMWPE and are available in symmetrical and asymmetrical designs.

Two femoral heads are available. The CoCrMo and ceramic head can be used with the cemented femoral component. The CoCrMo head can also be used with the Cementless femoral stem.

#### 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 for Femoral Stem Prostheses", .
- "Draft Guidance for Calcium Phosphate (Ca-P) Coating" was completed where applicable. .

#### SUBSTANTIAL EQUIVALENCE

The Aesculap Excia Total Hip System with µ-CaP® is essentially identical to the Excia Total Hip System (K042344), BiContact Hip System with u-CaP (K043079), and Trident Acetabular Shells: PS-HA (K001448).

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2006

Aesculap, Incorporated c/o Ms. Kathy A. Racosky Regulatory Affairs Associatc 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K060437

Trade/Device Name: Excia Total Hip System with µ-CaP® Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or Nonporous uncemented prosthesis Regulatory Class: II Product Code: MEH Dated: February 20, 2006 Received: February 24, 2006

Dear Ms. Racosky:

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 docs 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

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

Page 2 - Ms. Kathy A. Racosky

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.

Hecker Lemmer to

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

Enclosure

{4}------------------------------------------------

Page 1 of 1

#### B. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K060437

### Device Name: Excia Total Hip System with u-Cap®

#### Indication for Use:

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

The device is intended for:

- Patients suffering from severe hip 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 . epiphysis
- Patients suffering from disability due previous fusion .
- Patients with acute femoral neck fractures

The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without µ CaP®.

Prescription Use ×

(Part 21 CFR 801 Subpart D)

or Over-the-Counter Use (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)

Hulud Lemer

Division of General, Restorative and Neurological Devices

(Optional Format 3-10-98)

510(k) Number K060437