EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD

K060918 · Aesculap, Inc. · LZO · May 26, 2006 · Orthopedic

Device Facts

• Record ID: K060918
• Device Name: EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
• Applicant: Aesculap, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: May 26, 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 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 The Excluding Openent is arealized in. The other femoral stem is for uncemented fixation and manufactured from Ti with Ti plasma spray.

Device Story

Excia Total Hip System is a modular hip prosthesis; includes femoral stems (Ti with plasma spray for uncemented use; CoCrMo for cemented use) and ceramic femoral heads (28mm, 36mm). Device replaces hip joint in patients with severe hip disability or fractures. Used by orthopedic surgeons in clinical/surgical settings. Ceramic heads interface with 12/14 trunnion femoral stems; acetabular component is UHMWPE. System provides structural support for hip joint, restoring mobility and reducing pain. Clinical benefit derived from mechanical replacement of diseased or damaged hip joint components.

Clinical Evidence

Bench testing only. Testing performed in accordance with 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 materials.

Technological Characteristics

Materials: Ti alloy with Ti plasma spray (uncemented), CoCrMo (cemented), UHMWPE (acetabular insert), ceramic (femoral heads). Modular design with 12/14 trunnion. Mechanical fixation (cemented or uncemented).

Indications for Use

Indicated for patients requiring hip joint replacement due to severe hip disability from 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, 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 (K040191)
• DePuy Ceramic Femoral Heads (KQ31803)
• Alumina Ceramic Femoral Heads, 28 and 32 MM (K030724)

Submission Summary (Full Text)

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## K060918

MAY 26 2006

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

### Excia Total Hip System (12/14 Trunnion with Ceramic Head) April 3, 2006

COMPANY:

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

CONTACT:

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

TRADE NAME: Excia Total Hip System 12/14 Trunnion with Ceramic Head COMMON NAME: Femoral Hip Stem and ceramic head

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

888.3360. 888.3350. 888.3353 REGULATION NUMBER:

PRODUCT CODE: LWJ, JDI, LZO

### SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the 12/14 Trunnion with Ceramic Head is a line extension of Aesculap's Excia Total Hip System that was cleared (K042344). It is also substantially equivalent to the BiContact Hip System (K040191), DePuy Ceramic Femoral Heads (KQ31803) and Alumina Ceramic Femoral Heads, 28 and 32 MM (K030724).

### DEVICE DESCRIPTION

The Excia femoral component is available in two designs. One is manufactured from Ti with a plasma spray coating (Plasmapore). This component is intended for uncemented use. The other femoral component is manufactured from CoCrMo and is intended for cemented use. Both femoral components have a 12/14 trunnion.

The ceramic heads are available in head diameters of 28mm, and 36mm in three neck lengths each. They are for use only with the Ti alloy cementless stems. The cemented or cementless femoral stems may be used with the CoCrMo head that was cleared in BiContact (K040191). The acetabular insert is UHMWPE and is available

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in a 36mm symmetrical design. The 12/14 femoral component and ceramic head are in a Sontariyanction with Plasmacup (K042344) for total hip arthroplasty.

#### INDICATIONS 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, . r attents "Sunomatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- or the lemoral noad and honomon on one 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 The Excla Tip Uyston 16 Grandblo Mili first of the other femoral stem is for uncemented fixation and manufactured from Ti with a Ti plasma spray.

# TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

TEOTHOLIGIONE Of the Excia Total Hip System are offered in similar shapes and rhe fice as the predicate devices. The material used for the Aseculap device is the same as that used to manufacture the predicate devices.

### PERFORMANCE DATA

FERFORMANCE 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 . Othopedic 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 U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, placed to the right of the department's name. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the caduceus. The caduceus is depicted in black, and the text is also in black against a white background.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 2006

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

Re: K060918

Trade/Device Name: Excia Total Hip system 12/14 Trunnion with 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 Dated: May 2, 2006 Received: May 4, 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 comply with all the

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### Page 2 - Ms. Kathy Racosky

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,

Herbert Leuner us

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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Excla 12/14 Trunnion with Ceramic Head

Page 1 of 1

#### INDICATIONS FOR USE STATEMENT A.

12060918 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

# Device Name: Excia 12/14 Trunnion with 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 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 The Excluding Openent is arealized in. The other femoral stem is for uncemented fixation and manufactured from Ti with Ti plasma spray.

Hulut Leser

Division of General, Restorative, and Neurological Devices

**510(k) Number.** K060918

Prescription Use

and/or Over-the-Counter 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)