PRO-FEMUR R
Device Facts
| Record ID | K003016 |
|---|---|
| Device Name | PRO-FEMUR R |
| Applicant | Wrightmedicaltechnologyinc |
| Product Code | LWJ · Orthopedic |
| Decision Date | Dec 13, 2000 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 888.3360 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck and trochanteric fractures of the proximal 5. femur with head involvement that are unmanageable using other techniques.
Device Story
Modular revision hip prosthesis; comprises distal stem, extension adapter, proximal body, and modular neck. Distal stems available in short, medium, long lengths with cutting flanges for diaphyseal fixation; proximal bodies available in seven sizes; modular necks offer various anteversion/retroversion and varus/valgus options. Components secured via morse taper and fixation screws. Used by orthopedic surgeons in clinical settings for total hip arthroplasty. Provides structural support and joint function restoration for patients with degenerative joint disease or complex fractures. Benefits include improved hip function and pain relief through modular customization to patient anatomy.
Clinical Evidence
No clinical data provided; substantial equivalence supported by design features, materials data, and bench testing results.
Technological Characteristics
Modular hip prosthesis; components include distal stem, extension adapter, proximal body, and modular neck. Distal stems feature cutting flanges for primary fixation; secured via morse taper and fixation screws. Materials not specified by standard. Modular design allows for anatomical adjustment (anteversion/retroversion, varus/valgus).
Indications for Use
Indicated for skeletally mature patients undergoing total hip arthroplasty for non-inflammatory/inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, hip dysplasia, rheumatoid arthritis), functional deformity correction, revision procedures, or treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement.
Regulatory Classification
Identification
A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.
Submission Summary (Full Text)
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# DEC 1 3 2000
Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo consists of a stylized "W" on the left, followed by the company name in bold, uppercase letters. Below the company name is the address: 5677 Airline Road, Arlington, TN 38002, and the phone number: 901-867-9971.
## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the PRO-FEMUR R Revision Hip System.
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Device Product Code and Panel Code:
Wright Medical Technology, Inc.
September 26, 2000
Ehab M. Esmail Senior Regulatory Affairs Associate
PRO-FEMUR R
REVISION HIP SYSTEM
21 CFR 888.3358 Prosthesis, Hip, Semi-Constrained, metal/polymer, Uncemented - Class II Orthopedics/87/LPH
## DEVICE INFORMATION
## A. INTENDED USE
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:
- 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity;
- 4. revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal 5. femur with head involvement that are unmanageable using other techniques.
Image /page/0/Picture/25 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font. The logo is black and white.
Image /page/0/Picture/26 description: The image shows a black and white drawing of a globe. The globe is tilted on its axis and shows the continents of Asia, Australia, and parts of Africa. The globe is sitting on a stand.
510(K) SUMMARY
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The PRO-FEMUR R Revision Hip System are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.
### B. DEVICE DESCRIPTION
The PRO-FEMUR R Revision Hip System is a modular prosthesis comprising of four principal parts:
- · Distal stem with cutting flanges for the diaphyseal fixation
- · Extension Adapter
- · Proximal body for support in the metaphyseal region
- " Modular neck
The PRO-FEMUR R distal stem will be available in three different lengths, namely SHORT, MEDIUM, and LONG, in increments of 1mm from 10mm to 22mm in diameter. The SHORT distal stem (135mm) is straight, and the MEDIUM (175mm) and LONG (215mm) are both anatomically curved. All distal stems are slightly conical in profile and feature cutting flanges that provide excellent primary fixation. The cutting flanges are absent on the anterior and posterior curvature of the stem in order to reduce the possibility of femoral fracture during impaction.
The PRO-FEMUR R Proximal Body will be available in seven different sizes: Extra Small, Small, 4x Standard and Large. The four standard components have the same length but became progressively wider.
The distal stem is secured to the proximal body by morse taper and secondly by a fixation screw.
To further lengthen the implant by either 26 or 52 mm, extension adapters are available. They are positioned between the selected proximal body and distal stem and secured by morse taper and a longer fixation screw.
The proximal body has a specific oblong housing for the insertion of the twelve modular necks which are available in six versions and two lengths: Neutral, antiversion/ retroversion 8° or 15°, varus/ valgus 8°, or combination of anteverted/ retroverted - varus/ valgus (in both short and long lengths)
The design features of PRO-FEMUR R Revision Hip System are substantially equivalent to competitive devices previously cleared for market.
## C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material, type of interface, and design features of PRO-FEMUR R Revision Hip System are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the PRO-FEMUR R Revision Hip System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.
Image /page/1/Picture/16 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below the word "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.
Image /page/1/Picture/17 description: The image shows a globe with a focus on the continents of Asia and Australia. The globe is positioned at an angle, with the northern hemisphere tilted slightly towards the viewer. The landmasses are shaded to indicate topography, and the oceans are a lighter color. The globe is mounted on a stand, which is partially visible at the bottom of the image.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a wing-like structure at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## DEC 1 3 2000
Mr. Ehab M. Esmail Senior Regulatory Affairs Associate Wright Medical Technology Incorporated 5677 Airline Road Arlington, Tennessee 38002
Re: K003016
Trade Name: Pro-Femur R Revision Hip System Regulatory Class: II Product Code: LWJ Dated: September 26, 2000 Received: September 27, 2000
#### Dear Mr. Esmail:
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 sured in the encroune) to ceal Device Amendments, or to devices that have been reclassified in enceenhence 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 thereols, mainto and 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 ( remaired in pp. of cound 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.
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#### Page 2 - Mr. Ehab M. Esmail
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). "Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely, yours,
Mark N Mullane
- 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
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Image /page/4/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo consists of a stylized "W" on the left, followed by the company name in a serif font. Below the company name is the address "5677 Airline Road, Arlington, TN 38002" and the phone number "001 867 0071".
### PROFEMUR R REVISION HIP SYSTEM
### INDICATIONS STATEMENT
### 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:
- 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2) inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3) correction of functional deformity;
- 4) revision procedures where other treatments or devices have failed; and,
- 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
#### (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 Devices .510(k) Number
Prescription Use (Per21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)
for Mark N. Millhussen
(Division Sign Off)
(Division Sign-Off) Division of General Restorative Devices 510(k) Number.
Image /page/4/Picture/18 description: The image shows the text "KOO301" in what appears to be a handwritten style. Below the text is a logo that looks like a stylized letter "W" or an abstract geometric shape. The logo is in black and is positioned at the bottom center of the image.
Image /page/4/Picture/19 description: The image shows a globe with a focus on Asia and Australia. The globe is a simple, stylized representation, with the continents outlined in dark ink. The surrounding area of the globe is shaded, giving it a three-dimensional appearance. The image is a black and white graphic.
Image /page/4/Picture/20 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, serif typeface. Below "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font. The logo is simple and professional, conveying a sense of stability and innovation.
INDICATIONS STATEMENT
