PROTRACT PRESS FIT HIP STEM-HA COATED

K010241 · Stelkast Company · LPH · Feb 8, 2001 · Orthopedic

Device Facts

• Record ID: K010241
• Device Name: PROTRACT PRESS FIT HIP STEM-HA COATED
• Applicant: Stelkast Company
• Product Code: LPH · Orthopedic
• Decision Date: Feb 8, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic). 2. Revision of failed femoral head replacements. 3. When alternative reconstructive techniques are not viable. 4. When arthrodesis is contraindicated. 5. Avascular necrosis or fracture of the femoral head. 6. Congenital defects that will allow adequate function of the system.

Device Story

Protract Press-Fit Hip Stem is a femoral component for total hip arthroplasty; intended for implantation into the femur to replace the femoral head. Device features Hydroxyapatite (HA) coating to promote osseointegration. Used by orthopedic surgeons in hospital settings during hip replacement surgery. Provides structural support and articulation surface for hip joint function; benefits patients by restoring mobility and reducing pain associated with joint degeneration or trauma.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Femoral hip stem prosthesis; HA (Hydroxyapatite) coated surface; press-fit fixation design; metallic construction.

Indications for Use

Indicated for patients requiring hip arthroplasty due to arthritis (rheumatoid, osteoarthritis, post-traumatic), failed femoral head replacements, avascular necrosis, femoral head fracture, or congenital defects where alternative reconstruction is not viable or arthrodesis is contraindicated.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but in this case, it is a stylized representation of a human figure embracing a globe.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 8 2001

Mr. Donald A. Stevens President StelKast Company 800 Vinial Street, Suite B-210 Pittsburgh, Pennsylvania 15212

Re: K010241

Trade Name: Protract Press-Fit Hip Stem - HA Coated Regulatory Class: Class II Product Code: LPH Dated: January 23, 2001 Received: January 25, 2001

Dear Mr. Stevens:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

{1}------------------------------------------------

Page 2 - Mr. Donald A. Stevens

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific direction in the diagnostic devices), please contact the Office of Compliance at additionally 007.10 for millionally, for questions on the promotion and advertising of your device, [phone]. Traditional Compliance at [phone]. Also, please note the regulation prease connect the Office or Compilation expective (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibilities and more [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N Millman

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

{2}------------------------------------------------

510(K) Number (if known): 10102

Protract Press Fit Hip Stem - HA Coated Device Name:

## Indications For Use:

- 1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
- 2. Revision of failed femoral head replacements.
- 3. When alternative reconstructive techniques are not viable.
- When arthrodesis is contraindicated. 4.
- 5. Avascular necrosis or fracture of the femoral head.
- 6. Congenital defects that will allow adequate function of the system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N Melkers
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number K010241

Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)