(85 days)
The Type 3 Femoral Components are intended to be used in primary or revision total hip arthroplasty, specifically in the presence of severe proximal bone loss. These stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components. These femoral stems are designed to be press fit into the proximal femur.
The Type 3 Femoral Components are a series of Titanium femoral stems intended to be used for primary or revision total hip arthroplasty, specifically in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components. These stems are modular, with varying proximal body and distal stem sizes to accommodate various anatomical requirements. These femoral stems are designed to be press fit into the proximal femur. These femoral components are manufactured from Titanium alloy, Ti-6Al-4V, which conforms to the requirements of ASTM specification F 136.
The provided text is related to a 510(k) premarket notification for a medical device called "Type 3 Femoral Components." It details the device's intended use, materials, classification, and substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria for performance metrics, nor does it describe a study involving human readers, ground truth establishment, or sample sizes in the context of device performance in a clinical or AI-assisted scenario.
The only performance-related statement is: "Testing has demonstrated that the fatigue load carrying capacity of the Type 3 Femoral stems exceeds the minimum ISO load requirements." This is a engineering/mechanical performance test, not a clinical study involving human readers or AI.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth, training set sample sizes, or how training set ground truth was established. These details are typically found in documents describing clinical trials, software performance evaluation, or AI model validation, which is not the nature of this 510(k) summary.
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DEC 22 1998
510(k) Summary
Proprietary Name: Type 3 Femoral Components
Common Name: Hip Prosthesis
21 CFR 888.3353 Classification Name and Reference:
Hip Joint Metal/Ceramic/Polymer semi-constrained cemented or nonporous uncemented prosthesis.
Proposed Regulatory Class: Class II
Device Product Code: LZO
For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 9-25-98
The Type 3 Femoral Components are a series of Titanium femoral stems intended to be used for primary or revision total hip arthroplasty, specifically in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components. These stems are modular, with varying proximal body and distal stem sizes to accommodate various anatomical requirements. These femoral stems are designed to be press fit into the proximal femur.
These femoral components are manufactured from Titanium alloy, Ti-6Al-4V, which conforms to the requirements of ASTM specification F 136.
The substantial equivalence of these Femoral components is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Partnership™ Revision Femoral Components (K972893) and Modular Replacement System (K954559), Intermedics Orthopedics' Wagner Revision Stem (K960588) and Link's MP Reconstruction Hip System.
Testing has demonstrated that the fatigue load carrying capacity of the Type 3 Femoral stems exceeds the minimum ISO load requirements.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 1998
Mr. Frank Maas Manager, Requlatory Affairs Howmedica Inc. Pfizer Medical Technology Group 359 Vertans Boulevard Rutherford, New Jersey 07070-2584
K983404 Re : Type 3 Femoral Components Trade Name: Requlatory Class: II Product Codes: LZO, JDI, LWJ Dated: September 25, 1998 September 28, 1998 Received:
Dear Mr. Maas:
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 aqainst 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 Regulation (QS) for Medical Devices: General requlation (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 - Mr. Frank Maas
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 device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (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 ene origo on centified, "Misbranding by reference to premarket 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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Indications for Use
510(k) Number (if known): K98 3400
Device Name: Type 3 Femoral Components
Indications for Use:
The Type 3 Femoral Components are intended to be used in primary or revision total hip arthroplasty, specifically in the presence of severe proximal bone loss. These stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components. These femoral stems are designed to be press fit into the proximal femur.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
signature
(Division) Sign-Off)
Division of General Restorative Devices
510(k) Number K183404
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.