(85 days)
Not Found
No
The description focuses on the material, design, and intended use of a physical implant (femoral stem) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a femoral stem used in total hip arthroplasty, which is a medical procedure to treat a condition (severe proximal bone loss) and restore function.
No
This device is a femoral stem intended for use in hip arthroplasty, which is a surgical procedure to replace a joint. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states the device is a series of Titanium femoral stems, which are physical hardware components intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "primary or revision total hip arthroplasty," which is a surgical procedure performed in vivo (within the body).
- Device Description: The device is a "femoral stem," a type of implant used in hip replacement surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or treatment monitoring.
- Using reagents or other laboratory components.
The device is clearly an implantable medical device used in surgery, not a diagnostic tool used in vitro.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI, LWJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has demonstrated that the fatigue load carrying capacity of the Type 3 Femoral stems exceeds the minimum ISO load requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
2
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
3
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