(115 days)
Not Found
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as femoral components intended for use in surgery for conditions like rheumatoid arthritis, osteoarthritis, and avascular necrosis, which indicates a therapeutic purpose.
No
Explanation: This device is an orthopedic implant (femoral component) used in surgery, not for diagnosing conditions.
No
The device description clearly states it is a family of Cobalt-Chromium-Molybdenum (Vitallium) femoral stems, which are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a femoral component for use in hip replacement surgery. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the material and manufacturing of a femoral stem, which is a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, or any other components typically associated with IVD devices.
Therefore, the Reliance Long Stem Femoral components are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reliance® Long Stem Femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, avascular necrosis, metastatic lesions, or traumatic femoral fractures. These femoral components are intended to be used with Howmedica's V40™ femoral heads. Unipolar or Bipolar components, and acetabular components.
Product codes
LZO, JDI
Device Description
The Reliance® Long Stem Femoral Components consist of a family of Cobalt-Chromium-Molybdenum (Vitallium) femoral stems. These femoral components are manufactured from Cobalt-Chromium-Molybdenum (Vitallium) alloy, which meets the requirements of ASTM specification F 799.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Testing has demonstrated that the fatigue load carrying capacity of the Reliance® Long Stem Femoral Components exceeds the minimum ISO load requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
JUN 2 6 1998
R980813
510(k) Summary
Proprietary Name: Reliance® Long Stem 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 Fax: (201) 507-6870 Date Summary Prepared: 3-3-98
The Reliance® Long Stem Femoral Components consist of a family of Cobalt-Chromium-Molybdenum (Vitallium) femoral stems. These femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, avascular necrosis, metastatic lesions, or traumatic femoral fractures. These femoral components are intended to be used with Howmedica's V40™ femoral heads. Unipolar or Bipolar components, and acetabular components.
These femoral components are manufactured from Cobalt-Chromium-Molybdenum (Vitallium) alloy, which meets the requirements of ASTM specification F 799.
The substantial equivalence of the Reliance® Long Stem Femoral components is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Reliance® Total Hip system (K936126), Partnership Revision Femoral Components (K972893) and Modular Replacement System (K952970).
Testing has demonstrated that the fatigue load carrying capacity of the Reliance® Long Stem Femoral Components exceeds the minimum ISO load requirements.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 1998
Mr. Frank Maas 'Manager, Regulatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
K980813 Re: Reliance Long Stem Femoral Components Trade Name: Regulatory Class: II Product Code: JDI Dated: May 29, 1998 June 2, 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 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 Requlations, Title 21, Parts 800 to 895. ದ 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 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 - 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 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 ene regarderon choroned) 1125Randing mj 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): K980813
Device Name: Reliance Long Stem Femoral Components
Indications for Use:
The Reliance Long Stem Femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, revision surgery for pationis lesions, or traumatic femoral fractures. These avascular norooto, motablances to be used with Howmedica's V40™ femoral femoral components, and acetabular components, and acetabular components.
(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_
signature
(Optional Format 1-2-96
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980813
.