The PERFECTA® Femoral Stem with calcium sulfate coating is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - inflammatory degenerative joint disease such as rheumatoid arthritis; - correction of functional deformity; - revision procedures where other treatments or devices have failed; and, - treatment of fractures that are unmanageable using other techniques. The PERFECTA® Femoral Stem with calcium sulfate coating is for single use only, and is intended for use in conjunction with existing Wright Medical Technology ceramic or metal femoral heads, acetabular liners and shells, as a part of an uncemented total hip arthroplasty.
Device Story
PERFECTA® Femoral Stem is an orthopedic implant for uncemented total hip arthroplasty. Device features calcium sulfate coating applied to stem body; utilizes Wright Medical Technology 12/14 taper. Implanted by orthopedic surgeons in clinical/hospital settings to replace diseased or damaged femoral head/neck. Functions as structural component of hip joint replacement; interfaces with existing ceramic or metal femoral heads, acetabular liners, and shells. Provides mechanical stability and joint function restoration; intended to reduce pain and improve mobility in patients with degenerative joint disease or fractures. Single-use device.
Clinical Evidence
No clinical data provided; substantial equivalence based on design and material similarity to predicate devices.
Technological Characteristics
Femoral stem prosthesis; uncemented; features calcium sulfate coating; utilizes 12/14 taper; available in sizes 9-22.5 mm; intended for use with ceramic or metal femoral heads, acetabular liners, and shells.
Indications for Use
Indicated for skeletally mature patients requiring total hip arthroplasty for pain relief or improved function due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, revision of failed treatments, or unmanageable fractures.
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.
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K031402
NOV 2 2 2004
## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe in accordance with the room and in conformance with 21 CRF 807, this information serves as a Medical Dovices For of Serviveness for the use of the PERFECTA® Femoral Stem.
| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 2, 2003 |
| Contact Person: | Ehab M. Esmail<br>Senior Manager, Regulatory Affairs |
| Proprietary Name: | PERFECTA® Femoral Stem |
| Common Name: | TOTAL HIP SYSTEM |
| Classification Name and Reference: | 21CFR 888.3358 Hip joint metal/polymer/metal,<br>semi-constrained porous coated uncemented<br>prosthesis<br>21CFR 888.3350 Hip joint metal/polymer, semi-<br>constrained, cemented prosthesis - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ LPH, and JDI |
#### DEVICE INFORMATION
#### A. INTENDED USE
The PERFECTA® Femoral Stem with calcium sulfate coating is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1 . necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; 3.
- revision procedures where other treatments or devices have failed; and, 4.
- treatment of fractures that are unmanageable using other techniques. 5.
The PERFECTA® Femoral Stem with calcium sulfate coating is for single use only, and is intended for use in conjunction with existing Wright Medical Technology ceramic or metal femoral heads, acetabular liners and shells, as a part of an uncemented total hip arthroplasty.
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## B. DEVICE DESCRIPTION
DL VICE DEBOTED TIME .
The design features and functions of the first of the currently available The design features and functions of the Peter Petures of the currently available
coating will be identical to the 100 110 - 11 F000022, with the exception of the coating will be identical to the design features and railorions
PERFECTA® Femoral Stem (510(k): K991123 and K004032), with the exception of the calcium sulfate coating.
ourerally could be available in a range of sizes (9-22.5 mm) and will feature the All Tembral Dedical Technology (SLT) 12/14 taper.
# C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material, type of interface, and design features of the PERFECTA" The intended lise, malerial, type of microos, are substantially equivalent to the Femoral Stem with calciall suffato coating and control of the market (510(k): K991123 and K004032).
100 1052).
The safety and effectiveness of the PERFECTA® Femoral Stem with californation, marcrials The satety and effectiveness of the substial equivalence information materials
coating are adequatedy supported by the subscription Promarket Notification coating are adequately supported by the sabetainler of any and
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2004
Mr. Ehab M. Esmail Senior Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K031402
Rosi402
Trade/Device Name: Calcium Sulfate Coated Perfecta® Femoral Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: August 20, 2004 Received: August 24, 2004
Dear Mr. Esmail:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your 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 for use surved in the excess, 1976, the enactment date of the Medical Device Amendments, or to commerce processified in accordance with the provisions of the Federal Food, Drug, de noos that hat t over wat 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 rou mayy arous 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. Ehab M. Esmail
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wif anow you've ough finding of substantial equivalence of your device to a legally prematics notification. The Processification 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 acries in 1 240) 276-0120. Also, please note the regulation entitled, Connact the Office or Comment notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html .
Sincerely yours,
Cilia Wither
Celia M. Witten, PhD, MD Director Division of General, Restorative And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "WRIGHT." in all caps. Below the word is a graphic of three diagonal lines that are stacked on top of each other. Below the graphic is the letters "TM".
## PERFECTA® Femoral Stem INDICATIONS STATEMENT
510(k) Number (if known):
### Device Name: PERFECTA® Femoral Stem
Indications For Use:
The PERFECTA® Femoral Stem with calcium suffate coating is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis, 2.
- 3. correction of functional deformity;
- revision procedures where other treatments or devices have failed; and, 4.
- 5. treatment of fractures that are unmanageable using other techniques.
The PERFECTA® Femoral Stem with calcium sulfate coating is for single use only, and is intended for use in conjunction with existing Wright Medical Technology cerainic or metal femoral heads, acetabular liners and shells, as a part of an uncemented total hip arthroplasty.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over. The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| headquarters<br>Wright Medical Technology, Inc. | 5677 Airline Road Arlington, TN 38002 |
|-------------------------------------------------|---------------------------------------|
| 510(k) Number | K031402 |
| Phone | 901.867.9971 |
| Website | www.wmt.com |
| International subsidiaries | |
|----------------------------|-----------------------------|
| 011.32.2.378.3905 Belgium | 905.826.1600 Canada |
| 011.39.0250.678.227 Italy | 011.81.3.9538.0474 Japan |
| | 011.33.1.45.13.24.40 France |
| | 011.44.1483.721.404 UK |
| | 011.49.4161.745130 Germany |
