BICONTACT HIP SYSTEM WITH U-CAP

K043079 · Aesculap · MEH · Dec 8, 2004 · Orthopedic

Device Facts

• Record ID: K043079
• Device Name: BICONTACT HIP SYSTEM WITH U-CAP
• Applicant: Aesculap
• Product Code: MEH · Orthopedic
• Decision Date: Dec 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BiContact Hip System with u-CaP® (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 eptiphysis. Patients suffering from disability due to previous fusion. Patients with acute femoral neck fractures.

Device Story

BiContact Hip System with u-CaP® is a semi-constrained, metal/polymer, porous uncemented hip prosthesis. System components include a titanium femoral stem with Plasmapore® titanium plasma spray coating and a calcium phosphate (u-CaP®) layer, and a CoCrMo femoral head. The acetabular cup is manufactured from UHMWPE. Device is intended for surgical implantation by physicians to replace a diseased or damaged hip joint. It functions as a mechanical replacement to restore joint function and alleviate pain in patients with specified orthopedic conditions. Clinical benefit is derived from the restoration of hip joint mobility and reduction of pain.

Clinical Evidence

Bench testing only. Testing performed in accordance with FDA guidance documents for orthopedic implants, including: "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements", "Guidance Document for Testing Orthopedic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Implants", "Guidance Document for Testing Non-articulating, 'Mechanically Locked' Modular Implant Components", "Draft Guidance for Femoral Stem Prostheses", and "Draft Guidance for Calcium Phosphate (Ca-P) Coating".

Technological Characteristics

Materials: Titanium femoral stem with Plasmapore® (Ti plasma spray) and Calcium Phosphate coating; CoCrMo femoral head; UHMWPE acetabular cup. Design: Semi-constrained, porous uncemented hip prosthesis. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

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/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

• BiContact Hip System (K040191)
• Accolade-TMZF Plus HA Hip System (K023102)
• Taperloc Porous Femoral Stem & Ha Taperloc Porous (K020963)
• Corail (K953111)

Submission Summary (Full Text)

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# DEC - 8 2004

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

## BICONTACT HIP SYSTEM with u-CAP®

November 5, 2004

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

#### INTENDED USE

The BiContact Hip System with u-CaP® (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 . eptiphysis
- . Patients suffering from disability due to previous fusion
- Patients with acute femoral neck fractures .

#### DEVICE DESCRIPTION

The BiContact Hip System with u-CaP® is available in one design. The femoral stem is manufactured from Ti with a Ti plasma spray coating (Plasmapore®) and a layer of Calcium Phosphate. 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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043079

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### 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 BiContact Hip System with u-CaP® is essentially identical to the BiContact Hip System (K040191), Accolade-TMZF Plus HA Hip System (K023102), Taperloc Porous Femoral Stem & Ha Taperloc Porous (K020963) and the Corail (K953111).

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2004

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

Re: K043079

Trade/Device Name: BiContact Hip System with μ-Cap Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: MEH Dated: November 5, 2004 Received: November 9, 2004

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 10 mover ce 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. Kathy A. Racosky

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yours ough anding of substantial equivalence of your device to a legally prematicated predicated on "The 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 If you desire spocific acrievier - at [phone]. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain Whisofanding by reference to premains on your responsibilities under the Act from the Division of Small other general 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 N. Milhem

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

510(k) Number (if known):

K043079

Device Name: BiContact Hip System with u-CaP®

#### Indication for Use:

The BiContact Hip System with u-CaP® (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 ● eptiphysis
- Patients suffering from disability due to previous fusion .
- Patients with acute femoral neck fractures .

Mark A. Mullens

(Division Sign-Off)

Prescription Use __

(per 21 CFR 801.109)

or Over-the Dissio ral, Restorative. and Neurological Devices

510(k) Number K043079

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