EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD

K062684 · Aesculap, Inc. · LZO · Nov 22, 2006 · Orthopedic

Device Facts

• Record ID: K062684
• Device Name: EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
• Applicant: Aesculap, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 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 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 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 with or with of u CaP®.

Device Story

Excia 36mm Ceramic Head is a modular hip prosthesis component; manufactured from Al2O3 ceramic (ISO 6474). Device functions as a femoral ball head; provides articulation surface for total hip arthroplasty. Offered in three head lengths (-3.5mm, 0mm, +3.5mm) to accommodate patient anatomy. Used by orthopedic surgeons in clinical settings during hip replacement procedures. Device replaces damaged femoral head; restores joint function; reduces pain. System includes femoral stems (CoCrMo for cemented; Ti with Plasmapore/CaP for uncemented).

Clinical Evidence

Bench testing only. Testing performed per FDA guidance documents for orthopedic implants, including ceramic ball hip systems, acetabular cup prostheses, and metallic plasma-sprayed coatings.

Technological Characteristics

Material: Al2O3 ceramic (ISO 6474). Form factor: 36mm diameter modular ball head in three lengths (-3.5mm, 0mm, +3.5mm). System includes CoCrMo (cemented) or Ti with Plasmapore/CaP (uncemented) femoral stems. Non-active, mechanical implant.

Indications for Use

Indicated for patients with severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, nonunion of femoral fractures, congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, 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)
• Excia Total Hip System 12/14 Trunnion with Ceramic Head (K060918)

Submission Summary (Full Text)

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

K062684

Excia Total Hip System 36mm Ceramic Head

Page 1 of 2

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

NOV 2 2 2006

### Excia Total Hip System (Excia 36mm Ceramic Head) September 8, 2006

COMPANY:

Aesculap®, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714

CONTACT:

Kathy A. Racosky 800-258-1946 (phone) 610-791-6882 (fax) kathy [e-mail] (email)

TRADE NAME: Excia Total Hip System 36mm Ceramic Head

COMMON NAME: Ceramic Ball Head

CLASSIFICATION NAME: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented prosthesis Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate Prosthesis, hip, semi-constrained, metal/polymer, uncemented Prosthesis, hip, semi-constrained, metal/polymer, cemented

- REGULATION NUMBER: 888.3353, 888.3353, 888.3360, 888.3350
PRODUCT CODE: LZO, MEH, LWJ, JDI

## SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the 36mm Ceramic Head is a line extension of Aesculap's Excia Total Hip System that was cleared (K042344). It is also substantially equivalent to the Excia Total Hip System 12/14 Trunnion with Ceramic Head (K060918).

#### DEVICE DESCRIPTION

The Excia 36mm Ceramic Head is manufactured from ceramic (Al2O3) and conforms to ISO 6474. The 36mm diameter head is offered in three different head lengths (-3.5 mm, 0 mm, and +3.5mm). These ceramic heads allow the surgeon further option to meet the patient's needs.

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

Page 2 of 2

### 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 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 with or with of u CaP®.

# TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

The new 36mm ceramic head of the Excia Total Hip System are offered in similar shapes and sizes as the predicate devices. The material used for the Asecularia device is the same as that used to manufacture the predicate don'the .

### 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,

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

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2006

Aesculap, Inc. % Ms. Kathy A. Racosky Regulatory Affairs Associate 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K062684 Trade/Device Namc: Excia Total Hip System 36mm Ceramic Head 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, MEH Dated: November 14, 2006 Received: November 15, 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 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

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

Page 2 - Ms. Kathy A. Racosky

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 Parl 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,

Barbara Buechner

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

Enclosure

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

Excia Total Hip System 36mm Ceramic Head

Page 1 of 1

#### A. INDICATIONS FOR USE STATEMENT

510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name: Excia 36mm Ceramic Head

### 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 necosis 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 to 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 p CaP®.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------------------------|---------|
| (Division Sign-Off) | for MCM |
| Division of General, Restorative, and Neurological Devices | |

510(k) Number K062684