ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS

K050637 · Ortho Development Corp. · JDI · Sep 23, 2005 · Orthopedic

Device Facts

• Record ID: K050637
• Device Name: ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS
• Applicant: Ortho Development Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Sep 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for cemented use only. The device is intended for use in hip arthroplasty applications whose indications include: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic arthritis, acetabuli and painful hip dysplasia. 2. Previously failed surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of the femoral head. 5. Non-union of proximal femoral neck fractures. 6. Treatment of fractures that are unmanageable using other forms of therapy, benign or malignant bone tumors, congenital abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Device Story

Encompass™ Cemented Hip System is a semi-constrained cemented hip prosthesis used in total hip arthroplasty. Device components replace damaged hip joint structures to restore function. Intended for use by orthopedic surgeons in clinical settings. System relies on bone cement for fixation within the femoral canal and acetabulum. Benefits include pain relief and restoration of joint mobility for patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Semi-constrained cemented hip prosthesis. Materials include metal and polymer components consistent with 21 CFR 888.3350. Designed for cemented fixation. No software or electronic components.

Indications for Use

Indicated for patients requiring hip arthroplasty due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, painful hip dysplasia, failed prior surgery, proximal femoral neck fractures/dislocation, idiopathic avascular necrosis, non-union of femoral neck fractures, or bone tumors/congenital abnormalities with sufficient bone stock.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the snake-like figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

SEP 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William J. Griffin Regulatory and Clinical Affairs Manager Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020

Re: K050637

Trade/Device Name: Encompass™ Cemented Hip System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: September 2, 2005 Received: September 7, 2005

Dear Mr. Griffin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(t) press. In substantially equivalent (for the indications felerenced above and nave acterifically marketed predicate devices marketed in interstate for use stated in the enclosure) to regars actual to the Medical Device Americal Partic commerce prof to May 26, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuired in actre approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merciole, market the act res, cost include requirements for annual registration, listing of general controls provisions of the riot 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 If your device is classified (sociation major regulations affecting your device can
may be subject to such additional controls. Existing major hiay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I casta singerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of a station of the requirements of the Act that I DA has made a decorminations administered by other Federal agencies. You must or any redelal statutes and regulations annuding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, more and CFK Fart 607), fabeing (21 CFR Part 820); and 1f applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2001) - 10 mm (2006) - 10 your Section 510(k) This letter will anow you to ocgin maneting your and equivalence of your device to a legally

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Page 2– Mr. William J. Griffin

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 If you desire specific advice for your ac not to a control of the regulation entitled, colliati the Office of Comphane as (21 notification" (21CFR Part 807.97). You may obtain " Misoranuning by relevelee to premainters in the Act from the Division of Small other general information on your responsive Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

2. of 1 N. Valli

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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Indications for Use

K050637 510(k) Number (if known):

Device Name: Encompass™ Cemented Hip System

## Indications for Use

The device is intended for cemented use only. The device is intended for use in hip arthroplasty applications whose indications include:

- 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic Notably inpullion acetabuli and painful hip dysplasia.
- Previously failed surgery. 2.
- 3. Proximal femoral neck fractures or dislocation.
- 4. Idiopathic avascular necrosis of the femoral head.
- 5. Non-union of proximal femoral neck fractures.
- 5. Nori-union of proximal lomeral inmanageable using other forms of theraly.
- 6. Treatment or fractures that uro as nations in the structural Benigh of manghant bone tumore, congenital as spanish seat the prosthesis.
abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

202

Sign-Off) (Division Division of General, Restorative, and Neurological Devices

**510(k) Number** 1050637