CONSERVE TOTAL FEMORAL HEAD
Device Facts
| Record ID | K051348 |
|---|---|
| Device Name | CONSERVE TOTAL FEMORAL HEAD |
| Applicant | Wrightmedicaltechnologyinc |
| Product Code | JDL · Orthopedic |
| Decision Date | Aug 19, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3320 |
| Device Class | Class 3 |
| Attributes | Therapeutic |
Indications for Use
The CONSERVE® Total Femoral Head 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: 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; and, 4. revision procedures where other treatments or devices have failed The CONSERVE® Total Femoral Head is intended for single patient use only.
Device Story
CONSERVE® Total Femoral Head is a cobalt-chromium-molybdenum orthopedic implant used in total hip arthroplasty. It serves as a replacement femoral head articulating with an acetabular component. The device features a superfinished articulating surface and a WMT12/14 taper connection compatible with existing femoral stems. It is intended for use by orthopedic surgeons in clinical settings to reduce pain and improve hip function. The device is provided sterile for single-patient use. Clinical benefit is derived from the restoration of joint function and relief of pain associated with degenerative or inflammatory joint conditions.
Clinical Evidence
Bench testing only. In vitro hip wear simulator testing compared the CONSERVE® Total Femoral Head to the Metal TRANSCEND® Femoral Head (both 54mm diameter) over 5 million cycles using orbital bearing machines. Results showed the CONSERVE® device had an average of 10 times lower volumetric run-in wear rate and 3.2 times lower cumulative volumetric wear than the predicate. Note: In vitro simulator results do not quantitatively predict clinical wear performance.
Technological Characteristics
Material: Wrought cobalt-chromium-molybdenum (CoCr) alloy. Design: Superfinished articulating surface; WMT12/14 taper connection. Sizes: 36mm to 56mm. Energy source: None (mechanical implant). Sterilization: Sterilized.
Indications for Use
Indicated for skeletally mature patients undergoing total hip arthroplasty for non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), correction of functional deformity, or revision procedures.
Regulatory Classification
Identification
A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Predicate Devices
- Metal TRANSCEND® Femoral Heads (Larger Sizes)
Submission Summary (Full Text)
{0}------------------------------------------------
K051348 (pg 1 of 3)
AUG ] 9 2005
## 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 100d and in conformance with 21 CRF 807, this information serves as a Medical Devices 110 01 199 cities of the CONSERVE® Total Femoral Head.
| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 3, 2005 |
| Contact Person: | Theresa Leister<br>Regulatory Affairs Specialist |
| Proprietary Name: | CONSERVE® Total Femoral Head |
| Common Name: | Femoral Head |
| Classification Name and Reference: | 21 CFR 888.3320 Hip joint metal/ metal semi-<br>constrained, with a cemented acetabular component<br>prosthesis - Class III<br>21 CFR 888.3330 Hip joint metal/ metal semi-<br>constrained, with an uncemented acetabular<br>component prosthesis – Class III |
| Device Product Code and Panel Code: | Orthopedics/87/JDL<br>Orthopedics/87/KWA |
## DEVICE INFORMATION
## A. INTENDED USE
The CONSERVE® Total Femoral Head 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:
- 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; and,
- 4. revision procedures where other treatments or devices have failed
The CONSERVE® Total Femoral Head is intended for single patient use only.
{1}------------------------------------------------
KCS1348 (pg 2 of 3)
### B. DEVICE DESCRIPTION
#### Design Features
The design features of the CONSERVE® Total Femoral Head are summarized below:
- Manufactured from wrought cobalt-chromium-molybdenum .
- The articulating surface of the implants will be superfinished .
- Available sizes: 36mm, 38mm, 42mm, 42mm, 46mm, 48mm, 50mm, 52mm, 52mm, . 54mm, 56mm
- The taper connection is identical to previously cleared taper connections and is . intended to be used with our existing femoral stems manufactured with WMT12/14 taper.
#### Wear Claims
The following marketing claims will be made for the CONSERVE® Total Femoral Head:
- The articulation of the CONSERVE® Total Femoral Head Bearing has an average of . 10 times lower volumetric run-in wear rate than the currently available Metal TRANSCEND® Femoral Head Bearings. *
- The articulation of the CONSERVE® Total Femoral Head Bearing has an average of . 3.2 times lower cumulative volumetric wear than the currently available Metal TRANSCEND® Femoral Head Bearings. *
#### * Wear Test Information
- (a) The CONSERVE® Total Femoral Head and the Metal TRANSCEND® Femoral Head are manufactured by Wright Medical Technology, Inc.
- (b) The test device was the CONSERVE® Total Femoral Head and the control device was the Metal TRANSCEND® Femoral Head
- (c) Both the test and control devices were 54mm diameter femoral heads.
- (d) The articulating surface of both the test and control device was mirror finished.
- (e) The hip simulators used were orbital bearing hip wear test machines manufactured by Shore Western Manufacturing, Inc.
- (f) Both the test and control devices were tested for 5 million cycles.
- (g) The material of the device was a CoCr alloy and the bearing size was 54mm.
- (h) The lubricant used was 90% alpha calf serum with 0.2% sodium azide, 20mM EDTA and distilled water.
- (i) The average amount of volumetric wear at 5 million cycles for the test device was 1.02mm3 less than that of the control device.
- (j) Both the test and control devices were sterilized.
- (k) The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.
Image /page/1/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" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.
Image /page/1/Picture/26 description: The image shows a black and white drawing of a globe. The globe is tilted on its axis and is sitting on a stand. The continents of Asia and Australia are visible on the globe. The drawing is simple and has a vintage look.
{2}------------------------------------------------
Special 510(k)
CONSERVE® Total Femoral Head
510(K) SUMMARY
Page 3 of 3
K051348(pg 3 of 3)
# C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use and type of interface of the CONSERVE® Total Femoral Head are The intended use and type of internation Femoral Heads (Larger Sizes). The design features and material are substantially equivalent to the Metal TRANSCEND® Femoral Heads (Larger Sizes). The safety and effectiveness of this device are adequately supported by the substantial equivalence information, materials data, and testing results, provided within the Premarket Notification.
Image /page/2/Picture/4 description: The image shows a black and white drawing of a globe. The globe is tilted on its axis and is sitting on a stand. The continents are visible on the globe, but they are not labeled. The globe is surrounded by a ring, which may represent the equator or another line of latitude. The image is simple and straightforward, and it is likely intended to be used for educational purposes.
510(K) SUMMARY- Amended 8-3-05
WRIGHT
MEDICAL TECHNOLOGY, INC.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
# AUG 1 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Theresa Leister Regulatory Affairs Specialist Wright Medical Technology, Inc. . . . . . 5677 Airline Road Arlington, Tennessee 38002
Re: K051348
Trade/Device Name: NSERVE® Total Femoral Head Regulation Number: 21CFR 888.3320, 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component prosthesis, Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III
Product Code: JDL, KWA Dated: August 1, 2005 Received: August 2, 2005
Dear Ms. Leister:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bedeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered processions) in accordance with the provisions of the Federal Food, Drug, de necs mat nave been require approval of a premarket approval application (PMA). and Cosmetic Prov (110) market the device, subject to the general controls provisions of the Act. The I va mayy are or visions of the Act include requirements for annual registration, listing of general controls profice, 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 rr your device is elabilition (tional 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 than v 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.
{4}------------------------------------------------
Page 2 – Ms. Theresa Leister
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manxoting your and equivalence of your device to a legally premarket nothleadon: The PDA midning of castification 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 acvice for your accel (240) 276-0210. Also, please note the regulation entitled, comact the Office of Compullion in (21 CFR Part 807.97). You may obtain Misblanding by reference to premaintonions in the Act from the Division of Small other general information on your responsive Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oolbanhoon of the world the more of the many of the states html.
Sincerely yours,
Z
Michael W. Mollen
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
## Indications for Use
510(k) Number (if known):
Device Name: CONSERVE® Total Femoral Head
Indications For Use:
The CONSERVE® Total Femoral Head is indicated for use in total hip arthroplasty for reduction The CONSERVE® Total Fead is marcally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- allkylosis, protrasto accuse joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 5. conceedures where other treatments or devices have failed
The CONSERVE® Total Femoral Head is intended for single patient use only.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
2-1 - 1 - 1 - - -
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
**510(k) Number** k051348
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
