ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS

K053293 · Ortho Development Corp. · LPH · Feb 16, 2006 · Orthopedic

Device Facts

• Record ID: K053293
• Device Name: ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
• Applicant: Ortho Development Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 16, 2006
• 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™ Press-Fit Hip Stem is a femoral component for total hip arthroplasty. Designed for uncemented, press-fit fixation in the femoral canal. Used by orthopedic surgeons in clinical settings to replace diseased or damaged hip joints. Provides structural support and articulation for patients suffering from arthritis, fractures, or necrosis. Device is implanted during surgery; serves as the femoral portion of a hip prosthesis system.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design characteristics.

Technological Characteristics

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Materials include metal and polymer components. Designed for press-fit application. Class II device under 21 CFR 888.3358.

Indications for Use

Indicated for patients with impaired hip joint due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, failed previous surgery, proximal femoral neck fractures/dislocation, idiopathic avascular necrosis of 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 6 2006

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

Received: January 26, 2006

Re: K053293

KUS3293
Trade/Device Name: Encompass™ Press-Fit Hip Stem, 10x17 and 12x17 Extended Stems 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: January 24, 2006

Dear Mr. Griffin:

We have reviewed your Section 510(k) premarket notification of intent to market the devices WE liave reviewed your bection 910(t) promises are substantially equivalent (for the relerenced above and nave determined re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interslate comments, or to to May 20, 1978, the endedations of the provisions of the Amendments, of to devices that nave been require approval of a premarket approval of a premarket approval rederal Food, Drug, and Cosmette rior ( roo ( roo ket the device, subject to the general controls application (PMA). Tou may, mercione, market ins act include requirements for annual provisions of the Act. "The general controls provisions proctice, labeling, and prohibitions against misbranding and adulteration.

If your devices is classified (see above) into either class II (Special Controls) or class III (PMA), If your devices is classified (sec above) into it visting major regulations affecting your device
they may be subject to such additional controls. Existing major they may be subject to saen additional bonations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Ood or ements 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 devices comply with other requirements of the Act that FDA has made a decemmandi that young ther Federal agencies. You must or any Pederal Statutes and regulations adminding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), adomig (21 OFR Part 820), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Griffin

This letter will allow you to begin marketing your devices as described in your Section > 19(k) I his letter will anow you to ocgain marketing your avvivalence of your devices to + 'egally premarket notification. "The PDF Intamig of basication for your device and thus, permits your devices 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 do not the cated on the more the regulation carithed, Contact the Office of Comphance at (210) 276-01607 (21CFR Part 807.97). You may >blain " Misoranding by reference to premarker notifications of Single the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Oolisanner Filoww.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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## Ortho Development -- K053293 -- Press-Fit Hip Stem Encompass 10x17 and 12x17 Extended Stem Sizes

Indications for Use

-

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Encompass™ Press-Fit Hip Stem, 10x17 and 12x17 Extended Stems

Indications for Use

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

- 1. Notably impaired hip joint due to osteoarthritis, 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 neck fractures.
- 6. Treatment of fractures that are unmanageable using other forms of therapy.
- 7. Benign or malignant bone tumors, congenital dysplasia or other structural 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)

(Divisi Sign-Off)

Divisio of General, Restorative,

and Ne .. ological Devices

\$10(k) Number.