ENCORE CLP OFFSET TOTAL HIP SYSTEM

K052320 · Encore Medical Corporation · KWA · Dec 30, 2005 · Orthopedic

Device Facts

• Record ID: K052320
• Device Name: ENCORE CLP OFFSET TOTAL HIP SYSTEM
• Applicant: Encore Medical Corporation
• Product Code: KWA · Orthopedic
• Decision Date: Dec 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Encore CLP Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post - traumatic arthritis, collagen disorders, avascular necrosis, Protrusio Acetabuli, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip displasia, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Encore CLP Offset Hip Stem is intended for Cementless Applications

Device Story

Encore CLP Offset Total Hip System is a prosthetic hip replacement device designed for cementless application. It replaces damaged hip joint structures to alleviate pain and restore function in patients with severe arthritis, necrosis, or congenital/traumatic hip conditions. The system consists of a femoral stem component implanted into the femur to provide a stable foundation for the artificial joint. It is intended for use by orthopedic surgeons in a clinical/hospital setting. The device functions as a mechanical replacement for the natural hip joint, facilitating movement and weight-bearing. By restoring joint geometry and stability, it aims to improve patient mobility and quality of life.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cementless hip prosthesis; femoral stem component; metallic construction; designed for uncemented acetabular fixation.

Indications for Use

Indicated for patients requiring total or partial hip replacement due to severe pain/disability from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, Protrusio Acetabuli, femoral fracture non-union, congenital hip dysplasia, slipped capital femoral epiphysis, or previous fusion with inadequate bone stock.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Submission Summary (Full Text)

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DEC 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sam Son Vice President, Research and Development Official Correspondent Encore Medical Corporation 11201 Pepper Road Hunt Valley, Maryland 21031

Re: K052320

Trade/Device Name: Encore CLP™ Offset Total Hip System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Regulatory Crass: ***************************************************************** Dated: December 9, 2005 Received: December 12, 2005

Dear Mr. Son:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your boother is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreated to the Medical Device Amendments, or to devices that provision with the provisions with the provisions of the Federal Food, Drug, and Cosmetic nave boon roctablished in and require approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mancer 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 n your device to such additional controls. Existing major regulations affecting your device can be may be subject to sail adall Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act or that t Dry has mude a averaulations 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 latoring (DS) 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 - Mr. Son

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieting of substantial equivalence of your device to a legally premaired notification: "The PDF manily sification 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 II you desire specific at rice for your acc [phone]. Also, please note the regulation entitled, Colliact the Office of Comphanes and et notification" (21CFR Part 807.97). You may obtain other IMISoranding of reference to psystemsibilities under the Act from the Division of Small of general information on your responsibilities at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Mark M. Milliams

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

Enclosure

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**Food and Drug Administ**

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**CENTER FOR DEVICES AND RADIOLOGICAL HEALTH**

Rev. 2, 12/21/05

## Indications for Use

510(k) Number (if known): K052320

Device Name: Encore CLP Offset Total Hip System

Indications for Use:

The Encore CLP Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post - traumatic arthritis, collagen disorders, avascular necrosis, Protrusio Acetabuli, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip displasia, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

The Encore CLP Offset Hip Stem is intended for Cementless Applications

Prescription Use _ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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*(Posted November 13, 2003)*

Center for Devices and Radiological; Health estorative and Nearology

K052320
510(k) Number***_***_