(84 days)
The Patient Matched Flanged Acetabular Component is indicated for use in patients requiring reconstruction of the hip joint due to disease, deformity or trauma. The device is intended for either cemented or cementless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. The device is a single use implant. The device is to be used in conjunction with Biomet's RingLock Acetabular Liners. The device may be used in conjunction with any commercially available femoral component.
The Patient Matched Flanged Acetabular Component is an acetabular cup designed to match the natural geometry of an individual patient Matched Flanged Acefabular Component is matched to a particular patient, a specific device description is not possible.
This submission does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The provided text is a summary of safety and effectiveness, an FDA clearance letter for a 510(k) submission, and the indications for use for a "Patient Matched Flanged Acetabular Component."
Here's what can be extracted from the provided documents:
- Device Name: Patient Matched Flanged Acetabular Component
- Intended Use: Reconstruction of the hip joint due to disease, deformity, or trauma in skeletally mature individuals.
- Classification: Class II (Product Codes: LPH and JDI)
- Substantial Equivalence: Deemed substantially equivalent to predicate devices such as Healey™ Revision Acetabular Component, Recovery Protusio Cage, Universal® Acetabular Component, and Mallory-Head® Acetabular Component.
However, the documents do not include:
- A table of acceptance criteria and reported device performance.
- Details about a study (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance, ground truth type for testing or training, training set size, or how training ground truth was established).
This type of information is typically found in premarket approval (PMA) applications, design validation reports, or specific performance studies, which are not part of a standard 510(k) summary document. A 510(k) primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than providing detailed performance data against specific acceptance criteria.
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NOV 2 3 1998
Image /page/0/Picture/4 description: The image shows the logo for Biomet Inc. above the words "Corporate Headquarters". Above the logo is the text "K983035".
Summary of Safety and Effectiveness
Biomet, Inc. Sponsor: Airport Industrial Park Warsaw. Indiana 46580
Device Name: Patient Matched Flanged Acetabular Component
Classification Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis (888,3358) and Hip joint metal/polymer semi-constrained cemented prosthesis (888,3350)
Intended Use: The Patient Matched Flanged Acetabular Component is indicated for use in patients requiring reconstruction of the hip ioint due to disease, deformity or trauma. The device is intended for either cernentless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. The device is a single use implant. The device is to be used in conjunction with Biomet's RingLoo® Acetabular Liners. The device may be used in conjunction with any commercially available femoral component.
Device Description: The Patient Matched Flanged Acetabular Component is an acetabular cup designed to match the natural geometry of an individual patient Matched Flanged Acefabular Component is matched to a particular patient, a specific device description is not possible.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Reaction to the bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/mioration Breakdown of the porous surface
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Tissue growth failure
Bone fracture Infection Hematoma Dislocation Excessive wear Nerve damage
Substantial Equivalence: The Patient Matched Flanged Acetabular Component is substantially equivalent to almost all acetabular devices on the market in overall design and intended function. Predicate devices include:
Healeym Revision Acetabular Component Recovery Protusio Cage Universal® Acetabular Component Mallory-Head® Acetabular Component
MAILING ADDRESS 1,0. Box 587 Warsaw. IN 46581-0587
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
1
OFFICE 219,267.6639
ドヘン 219.267.8137
E-MAIL גווגווגוווגוווווווווווווווו
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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1998
Ms. Patricia S. Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
Re: K983035 Patient Matched Flanged Acetabular Component Trade Name: Regulatory Class: II Product Codes: LPH and JDI Dated: August 27, 1998 August 31, 1998 Received:
Dear Ms. Beres:
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 Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.
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Page 2 - Ms. Patricia S. Beres
This letter will allow you to begin marketing your device as described in your 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 markees problems, 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 compriation 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 ene royal notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be 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,
Celia 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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51.0 (k) Number (if known): k 983035
Device Name: Patient Matched Flanged Acetabular Component
0219 372 1790
Indications For Use:
Flanged Acetabular Component is indicated for use in patients The Patient Matched requiring reconstruction of the hip joint due to disease, deformity or trauma. The device is intended for either cemented or cementless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip The joints. device is a single use implant. The device is to be used in conjunction with Biomet's The device may be used in conjunction with any commercially RingLock Acetabular Liners. available femoral component.
BIOMET ACC/LEGAL
tcoeeep
Prescription Use
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 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.