EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM

K092143 · Aesculap Implant Systems, Inc. · MEH · Sep 22, 2009 · Orthopedic

Device Facts

• Record ID: K092143
• Device Name: EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
• Applicant: Aesculap Implant Systems, Inc.
• Product Code: MEH · Orthopedic
• Decision Date: Sep 22, 2009
• 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 without u-CaP®.

Device Story

Excia Total Hip System M and ML femoral stems are orthopedic implants designed to replace a hip joint. The system includes two stem variants: a CoCrMo stem for cemented fixation and a Titanium (Ti) stem with Plasmapore coating (with or without u-CaP) for uncemented fixation. The stems feature 8/10 or 12/14 tapers. Used by orthopedic surgeons in a clinical/surgical setting, the device provides a structural replacement for the femoral component of the hip joint. By restoring joint function and stability, the device aims to alleviate pain and disability associated with degenerative or traumatic hip conditions. The device is a line extension of existing Aesculap hip systems.

Clinical Evidence

Bench testing only. No clinical data provided. Testing performed per FDA guidance for orthopedic implants, including evaluations of metallic plasma-sprayed coatings, non-articulating modular components, acetabular cup prostheses, femoral stem prostheses, ceramic ball hip systems, and UHMWPE materials.

Technological Characteristics

Femoral hip stem; materials include Titanium (Ti) with Plasmapore coating (with or without u-CaP) or CoCrMo; 8/10 or 12/14 taper options; uncemented or cemented fixation; semi-constrained design. No software or electronic components.

Indications for Use

Indicated for patients requiring hip joint replacement 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 (K042344)
• Excia (K060437)
• Excia (K060918)
• Excia (K061344)

Submission Summary (Full Text)

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Excia Total Hip System M and ML Femoral Stem

# K092143

Page 1 of 2

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

# SEP 2 2 2009

### Excia Total Hip System M and ML Femoral Stem

#### July 13, 2009

Aesculap Implant Systems, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311

- CONTACT: Kathv A. Racosky 610-984-9291 (phone) 610-791-6882 (fax) kathy [e-mail] (email)
- TRADE NAME: Excia Total Hip System
- COMMON NAME: Femoral Hip Stem
- Hip ioint Metal/Ceramic/Polymer Semi-Constrained CLASSIFICATION NAME: Cemented or Non-Porous Uncemented Prosthesis

#### REGULATION NUMBER: 888.3353

PRODUCT CODE: LZO, LWJ, MEH, KWY

### SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, Inc. believes that Excia M and ML femoral stem is a line extension of Aesculap Implant Systems Excia (K042344, K060437, K060918, and K061344).

## DEVICE DESCRIPTION

The Excia M and ML femoral stem are available in one design. The femoral stem is manufactured from TI with a plasma spray coating (Plasmapore) with U-CaP®. The Excia M and ML femoral stem will be offered in an 8/10 or 12/14 taper. This component is intended for uncemented use.

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K092143

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 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®.

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

The new Excia M and ML femoral stems of the Excia Total Hip System are offered in similar shapes and sizes as the predicate devices. The material used for the Aesculap Implant Systems device is the same as that used to manufacture the predicate devices.

### 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.

SEP 2 2 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K092143

Trade/Device Name: Excia Total Hip System M and ML Femoral Stem 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, LZO, LWJ, KWY Dated: August 25, 2009

Received: August 26, 2009

#### 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 -- Ms. Kathy A. Racosky

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Oarlare buelup

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

Enclosure

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Page 1 of 1

#### A. INDICATIONS FOR USE STATEMENT

#### K092143 510(k) Number:

Device Name: Excia Total Hip System M and ML Femoral Stem

#### 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 without u-CaP®.

Sonata for mxn

(Division Signe (DWision Sign-Oir)
Division of Surgical, Orthopedic, Division of Survices

510(k) Number K092143

and/or Over-the-Counter Use × 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)