BICONTACT HIP STEM AND FEMORAL HEAD

K040191 · Aesculap · LPH · Aug 25, 2004 · Orthopedic

Device Facts

• Record ID: K040191
• Device Name: BICONTACT HIP STEM AND FEMORAL HEAD
• Applicant: Aesculap
• Product Code: LPH · Orthopedic
• Decision Date: Aug 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BiCONTACT Hip System (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) 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 to previous fusion - Patients with acute femoral neck fractures

Device Story

BiCONTACT Hip System; semi-constrained hip prosthesis for joint replacement. Components include femoral stem (titanium with Plasmapore plasma spray coating for uncemented fixation) and CoCrMo femoral head; acetabular cup manufactured from UHMWPE. Used by orthopedic surgeons in clinical settings to restore hip function; alleviate pain/disability in patients with degenerative or traumatic hip conditions. Device provides mechanical structural support for hip joint; benefits patient through improved mobility and pain reduction.

Clinical Evidence

Bench testing only. Testing performed per FDA guidance documents for orthopedic implants, including modified metallic surfaces, non-articulating modular components, and femoral stem prostheses.

Technological Characteristics

Materials: Titanium (stem) with Plasmapore plasma spray coating, CoCrMo (femoral head), UHMWPE (acetabular cup). Uncemented fixation. Semi-constrained design. No software or electronic components.

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 of 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/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• 36mm V40 Femoral Head Components (K022077)
• Accolade TMZF Plus HA 127° Size Hip System (K023102)
• MAYO Conservative Hip Prosthesis (K030733)
• Smith & Nephew Hip System (K022902)
• Zimmer Anatomic (K041109)

Submission Summary (Full Text)

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# AUG 2 5 2004

Page 1 of 2

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS C. [in Accordance with SMDA of 1990]

**BiCONTACT Hip System**

K 04019/

January 26, 2004

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

- CONTACT: Joyce Kilroy 800/258-1946 x 5074 (phone) 610/791-6882 (fax)
BiCONTACT TRADE NAME:

COMMON NAME: BiCONTACT Hip System

DEVICE CLASS: Class II

PRODUCT CODE: LPH

- CLASSIFICATION: 888.3358 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
REVIEW PANEL: Orthopedics

### INDICATIONS FOR USE

The BiCONTACT Hip System (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) 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 to previous fusion ◆
- Patients with acute femoral neck fractures ◆

### DEVICE DESCRIPTION

The BICONTACT Hip Stem and Femoral Head are available in one design. The femoral stem is manufactured from Ti with a Ti plasma spray coating (Plasmapore). This component is intended for uncemented use. A CoCrMo femoral head is available. The acetabular cup is manufactured solely of UHMWPE.

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Page 2 of 2

040/91

### 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 Document for Testing Non-articulating, "Mechanically Locked" Modular . Implant Components", and
- "Draft Guidance for Femoral Stem Prostheses" was completed where applicable. .

## SUBSTANTIAL EQUIVALENCE

Aesculap believes that the new BiCONTACT Hip Stem and Femoral Head is substantially equivalent in design to:

- . 36mm V40 Femoral Head Components (K022077)
- Accolade TMZF Plus HA 127° Size Hip System (K023102) .
- . MAYO Conservative Hip Prosthesis (K030733)
- Smith & Nephew Hip System (K022902) .
- Zimmer Anatomic (K041109) 9

-

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2004

Ms. Joyce Kilroy Director, Regulatory Affairs and Quality Assurance Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K040191

Trade/Device Name: BiContact Hip Stem and Femoral Head Regulation Number: 21 CFR 888.3358 Regulation Name: Prosthesis, Hip, semi-constrained, metal/polymer, porous uncemented Regulatory Class: II Product Code: LPH Dated: August 12, 2004 Received: August 13, 2004

Dear Ms. Kilroy:

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 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.

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Page 2 - Ms. Joyce Kilroy

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,

Mark A. Millan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT B.

Page 1 of 1

K040191 510(k) Number:

BiCONTACT Hip System Device Name;

Indication for Use:

The BiCONTACT Hip System (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) 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 to previous fusion ●
- Patients with acute femoral neck fractures .

Mark A. Milliken

Restorative, and Neurological

K04019
mber

Prescription Use X

(per 21 CFR 801.109)

or Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)