(146 days)
Indications for use include a severe disabling and/or painful hip associated with the following indications: 1) Osteoarthritis, 2) Traumatic arthritis, 3) Rheumatoid arthritis, 4) Advanced avascular necrosis, 5) Congentital hip dysplasia, and 6) Slipped captial femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.
The all-metal cobalt chrome TARA Resurfacing device is a single unit component and is porous coated on the inner cylindrical wall and ceiling only. The cobalt chrome porous coating is a -45 +60 Mesh x .030" thick surface coating. The all-metal TARA is only avaiable in the short stem version, again with nine head sizes from 38mm to 55mm in 2 mm increments. The all-metal TARA is fixed to the bone with cement.
This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The provided text is a 510(k) summary and an FDA clearance letter for the BIOPRO TARA Femoral Resurfacing Component. These documents outline the device's substantial equivalence to predicate devices, its intended use, and its classification. They do not detail specific performance acceptance criteria or report on studies designed to demonstrate the device meets such criteria. Typically, performance data and acceptance criteria are found in a separate section of the 510(k) submission, not summarized in these publicly available portions.
Therefore, I cannot provide the requested information based on the given text.
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K043542 page 1 of 1
Section XII: 510(k) Summary of Safety and Effectiveness SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary NAME OF FIRM: BioPro, Inc .. 17 Seventeenth St.. Port Huron, MI 48060 Dave Mrak 510(k) FIRM CONTACT: BIOPRO TARA Femoral Resurfacing Component TRADE NAME: Femoral Resurfacing Component COMMON NAME: CLASSIFICATION: Prosthesis, Hip, Femoral Resurfacing (see 21 CRF, Sec. 888.3400). DEVICE PRODUCT CODE: KXA SUBSTANTIALLY DePuy ASR Resurfacing Femoral Heads (K032659) EQUIVALENT DEVICES: Cormet 2000 Hemi Hip Metallic Resurfacing Prosth. (K994153) Biomet Press-Fit Head Resurfacing Device (K023188) Wright Medical CONSERVE Femoral Surface Replacement The all-metal cobalt chrome TARA Resurfacing device is a single DEVICE DESCRIPTION: unit component and is porous coated on the inner cylindrical wall and ceiling only. The cobalt chrome porous coating is a -45 +60 Mesh x .030" thick surface coating. The all-metal TARA is only avaiable in the short stem version, again with nine head sizes from 38mm to 55mm in 2 mm increments. The all-metal TARA is fixed to the bone with cement. Indications for use include a severe disabling and/or painful hip INTENDED USE: associated with the following indications: 1) Osteoarthritis, 2) Traumatic arthritis, 3) Rheumatoid arthritis, 4) Advanced avascular necrosis, 5) Congentital hip dysplasia, and 6) Slipped
captial femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.
- The BIOPRO all-metal TARA Femroal Resurfacing component is BASIS OF SUBSTANTIAL substantially equivalent to the DePuy, Corin. Biomet, and Wright EQUIVALENCY: Medical Femoral Resurfacing Hip components.
SUMMARY OF SAFETY The BIOPRO TARA Femoral Resurfacing all-metal system are AND EFFECTIVENESS: shown to be safe and effective for use in Hemi Resurfacing for the femoral head in the hip.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized representation of a human figure, composed of three curved lines, symbolizing health and well-being. Encircling the figure is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2005
Mr. David Mrak Director of Product Development Biopro Incorporated 17 Seventeenth Street Port Huron, Michigan 48060
Re: K043542
Trade/Device Name: TARA Femoral Resurfacing Regulation Number: 21 CFR 888.3400 Regulation Name: Hip joint femoral (hemi-hip) metallic resurfacing prosthesis Regulatory Class: II Product Code: KXA Dated: April 4, 2005 Received: April 6, 2005
Dear Mr. Mrak:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boomed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prior to they 2005 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 r lease be a rised a determination that your device complies with other requirements of the Act that I Dr has Intatutes and regulations administered by other Federal agencies. You must or any I valuated and streequirements, 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. David Mrak
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your to ongine of substantial equivalence of your device to a legally premative neuireaden." ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' 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 dome specific as not 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 other general mitetimational 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,
Stupt Rlurchu
Miriam C. Provost, Ph.D. Acting 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/3/Picture/0 description: The image shows the words "Biologically Oriented Prostheses" at the top. Below that, the word "BIOPRO" is displayed in a large, bold font. The letters are contained within a black rectangle. The letter "O" is half black and half white.
17 Seventeenth Street, Port Huron, MI 48060
510(k) NUMBER: __ K 0435-42 DEVICE NAME: ITARA Femoral Resurfacing INDICATIONS FOR USE:
Indications for use include a severe disabling and/or painful hip associated with the following indications: 1) Osteoarthritis, 2) Traumatic arthritis, 3) Rheumatoid arthritis, 4) Advanced avascular necrosis, 5) Congentital hip dysplasia, and 6) Slipped captial femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.
Over-The-Counter-Use X OR Prescription Use (Optional Format) (Per 21 CFR 801.109) Division of General, Restorative. and Neurological Devices Section X1 Design C "Design By Reason
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing 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 resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.