(100 days)
The device is intended for cemented use only in hip arthroplasty applications whose indications include:
- Osteoarthritis, Rheumatoid arthritis, or other Osteoarthrosis 1.
-
- Certain femoral neck fractures or dislocation
-
- Post traumatic arthritis
- Idiopathic avascular necrosis of the femoral head 4.
- Benign or malignant bone tumors where sufficient bone stock exists to seat the 5. prosthesis
- Previously failed surgery 6.
Legend™ All-poly Cup
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies related to the Legend™ All-poly Cup. The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use. It does not include details on how the device's performance was evaluated against specific acceptance criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
SEP = 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William J. Griffin Regulatory and Clinical Affairs Manager Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020
Re: K051407
Trade/Device Name: Legend™ All-poly Cup Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI, LPH Dated: August 22, 2005 Received: August 24, 2005
Dear Mr. Griffin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becared the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surver in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conniner of the rias 2011-12-11 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 I ou may, after exercy 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 rr your device is exactive 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. William J. Griffin
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 (240) 276-0120. 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 Mace facturers, 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/industry/support/index.html.
Sincerely yours,
Neil R.P. Oydem
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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קער זייער צוטע ווערן גווועקטער (גיין ריין ריי רייער וויינער וו
Indications for Use of Device Form
| 510(k) Number (if known): | K051407 |
|---|---|
| --------------------------- | --------- |
Device Name: Legend™ All-poly Cup
Indications for Use
The device is intended for cemented use only in hip arthroplasty applications whose indications include:
- Osteoarthritis, Rheumatoid arthritis, or other Osteoarthrosis 1.
-
- Certain femoral neck fractures or dislocation
-
- Post traumatic arthritis
- Idiopathic avascular necrosis of the femoral head 4.
- Benign or malignant bone tumors where sufficient bone stock exists to seat the 5. prosthesis
- Previously failed surgery 6.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RPD
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K051407
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.