(88 days)
The LSF "HA" COATED TRIAD TOTAL HIP SYSTEM is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (LSF HA Coated Triad Total Hip System). It does not contain information about acceptance criteria, device performance, sample sizes for studies, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.
The letter explicitly states: "You may not label or in any way promote these devices for "enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional porous coated hip prosthesis (i.e., biological fixation, only)."
This indicates that the clearance was based on substantial equivalence to a predicate device, rather than a study demonstrating specific performance against predefined acceptance criteria for the claims you are asking about.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 1998
Mr. Sam Son Vice President of Technical Affairs OsteoImplant Technoloqy Inc. 11201 Pepper Road Hunt Valley, Maryland 21031-1201
K974506 Re : LSF HA Coated Triad Total Hip System Requlatory Class: II Product Codes: LPH and MEH Dated: November 25, 1997 Received: December 1, 1997
Dear Mr. Son:
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 enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal This decision is based on Food, Drug, and Cosmetic Act (Act). consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:
You may not label or in any way promote these devices for "enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional porous coated hip prosthesis (i.e., biological fixation, only).
Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.
The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.
Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes 895. 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. 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 immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
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 gener Other general information on your responsibilities under the Act may be
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obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): $10(k) 97 4 S Φ < Device Name: LSF "HA" COATED TRIAD TOTAL HIP SYSTEM
Indications For Use:
The LSF "HA" COATED TRIAD TOTAL HIP SYSTEM is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Divided Size: 08
(Division Sign-Off) Division of General Restorative Devices 510(k) Number __ 1474506
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.