(91 days)
The CONSERVE® Plus HA Acetabul: r Shells are indicated for use in total hip arthroplast! 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 ac tabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformi y; and, 3.
-
- revision procedures where other treatments or devices have failed
The CONSERVE® Plus HA Acetabular Shells are intended for single patient use only.
A Hydroxylapetite (HA) coating is being a lded to the following previously cleared CONSERVE® Shells: CONSERVE® Plus Thin Shell, CONSERVE® Plus Spiked Shell, CONSERVE® Total SuperFix Shell, CONSERVE® Plus Thick & hell
{
"1. A table of acceptance criteria and the reported device performance": "The provided document is a 510(k) summary for a medical device, the CONSERVE® Plus HA Acetabular Shells. It states that the device is \"substantially equivalent\" to previously cleared predicate devices. Therefore, specific acceptance criteria and detailed device performance metrics (e.g., in a table format) that would typically be found in a clinical trial report are not present. The basis for acceptance is essentially the demonstration of substantial equivalence to existing devices.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "This document does not describe a study involving a test set, human subjects, or data provenance in the context of performance evaluation. The substantial equivalence argument relies on \"materials data, and testing results\" but does not specify sample sizes for these tests, nor their origin or type (retrospective/prospective)."
}
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DEC 17 2004
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Adr inistration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in confor nance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the Ise of the CONSERVE® Plus HA Acetabular Shell.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | September 15, 2004 |
| Contact Person: | Jeanine H. ReddenRegulatory Affairs Specialist II |
| Proprietary Name: | CONSERVE® Plus HA Acetabular Shells |
| Common Name: | Acetabular Shells |
| Classification Name and Reference: | 21 CFR 888.3330 Hip joint metal/ metal semi-constrained, with an uncemented acetabular componentprosthesis - Class III |
| Device Product Code and Panel Code: | Orthopedics/87/KWA |
DEVICE INFORMATION
A. INTENDED USE
The CONSERVE® Plus HA Acetabul: r Shells are indicated for use in total hip arthroplast! 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 ac tabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformi y; and, 3.
-
- revision procedures where other treatments or devices have failed
The CONSERVE® Plus HA Acetabular Shells are intended for single patient use only.
B. DEVICE DESCRIPTION
A Hydroxylapetite (HA) coating is being a lded to the following previously cleared CONSERVE® Shells: CONSERVE® Plus Thin Shell, CONSERVE® Plus Spiked Shell, CONSERVE® Total SuperFix Shell, CONSERVE® Plus Thick & hell
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C. SUBSTANTIAL EQUIVALENCE INFORMATION
The CONSERVE® Plus HA Acetabular Shells are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of the CONSERVE® Plus HA Acetabular Shells is a lequately supported by the substantial equivalent information, materials data, and testin 3 results provided within this Premarket Notification.
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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jeanine H. Redden Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K042530
Trade/Device Name: Conserve® Plus HA Acetabular Shells Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA
DEC 17 2004
Dated: December 7, 2004 Received: December 8, 2004
Dear Ms. Redden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) that 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 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 (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 - Ms. Jeanine H. Redden
This letter will allow you to begin marketing your device as described in your Section 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,
Lulia Witt
Celia 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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Indications for Use
K042530 510(k) Number (if known):
Device Name: CONSERVE® Plus HA Shells
Indications For Use:
The CONSERVE® Plus HA Shells are indicated . or use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in :keletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip < ysplasia;
- inflammatory degenerative joint disease such a: rheumatoid arthritis; 2.
- correction of functional deformity; and, 3.
-
- revision procedures where other treatments or devices have failed
The CONSERVE® Plus HA Shells are intended for single patient use only.
Prescription Use (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)
Glen Wolff
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
ostorative, Division of Gener and Neurological Devices
513(2) Number
2 2
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented 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. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.