ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER

K042565 · Ortho Development Corp. · LPH · Apr 11, 2005 · Orthopedic

Device Facts

• Record ID: K042565
• Device Name: ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
• Applicant: Ortho Development Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Apr 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is Intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only.

Device Story

Encompass™ Plasma Sprayed, Press-fit Hip System consists of hip stem, acetabular shell, and DCM liner. Designed for total hip arthroplasty via uncemented, press-fit surgical technique. Used by orthopedic surgeons in hospital settings to replace diseased or damaged hip joints. Provides structural support and articulation for patients suffering from arthritis, fractures, or necrosis. Benefits include restoration of joint function and mobility.

Clinical Evidence

Bench testing only.

Technological Characteristics

Hip prosthesis system; components include hip stem, acetabular shell, and DCM liner. Features plasma-sprayed porous coating for uncemented, press-fit fixation. Materials include metal and polymer components consistent with 21 CFR 888.3358 classification for semi-constrained porous-coated uncemented prostheses.

Indications for Use

Indicated for total hip arthroplasty in patients with impaired hip joint due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, failed previous surgery, proximal femoral neck fractures or dislocation, idiopathic avascular necrosis of the femoral head, non-union of proximal femoral neck fractures, fractures unmanageable by other therapies, or benign/malignant bone tumors, congenital dysplasia, or structural abnormalities with sufficient bone stock.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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APR 1 ] 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: K042565

Trade/Device Name: Encompass™ Plasma Sprayed, Press-fit Hip System: Encompass™ Hip Stem, Tri-plus™ Acetabular Shell, Tri-plus™ DCM Liner Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, MBL Dated: March 11, 2005 Received: March 14, 2005

Dear Mr. Griffin:

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 - Mr. William J. Griffin

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 240-276-0120. 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/industry/support/index.html.

Sincerely yours,

Atyck Rhodes
Miriam Provost, Ph.D.

Miriam Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ortho Development - K042565 - Porc us, Press-Fit Hip System, Plasma Coated

Indicat ons for Use

K042565 510(k) Number (if known): ____

Device Name: Encompass™ Plasma Sprayed , Press-Fit Hip System

Indications for Use

The device is Intended for use in total hij› arthroplasty. The device is intended for uncemented, press-fit use only.

- 1. Notably impaired hip joint due to usteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
- 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 ne :k fractures.
- 6. Treatment of fractures that are un nanageable using other forms of therapy.
- 7. Benign or malignant bone tumors congenital dysplasia or other structural abnormalities where sufficient bo re stock exists to properly seat the prosthesis.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
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AND/OR

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

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Concurrence of CDRH, Oflice of Device Evaluation (ODE)

*Stud*

(Division Sign-Off)

Division of General. Restorative,
and Neurological Devices

510(k) Numbe