(89 days)
Not Found
No
The description focuses solely on the mechanical components and intended use of a surgical implant for bone replacement. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes
The device is a medical implant designed to replace bone due to severe bone loss, specifically in oncological diagnoses or limb salvage, indicating it is used for treatment to improve a patient's health or quality of life.
No
This device is described as a system designed to replace the femur or a portion of it, indicating it is an orthopedic implant for treatment, not for diagnosing conditions.
No
The device description clearly outlines a physical implantable system consisting of modular components designed to replace portions of the femur. It describes hardware components like stems, shafts, and knee components, and mentions their use with bone cement. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant designed to replace a portion or the entire femur bone. It is a physical device implanted into the body.
- Intended Use: The intended use is to replace bone in cases of severe bone loss, primarily due to oncological diagnoses or limb salvage. This is a surgical intervention, not a diagnostic test performed on a specimen.
The device described is a surgical implant or prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
The Salvage/Oncology Hip and Total Femur System is designed to replace the either the encire femur or a large portion of the proximal femur in cases of severe bone loss most commonly due to oncological diagnoses or limb salvage following multiple revisions.
The device requires the use of a modular head, acetabular component and when used as a total femur replacement a Finn Knee tibial component.
All components of this system are indicated for use with bone cement.
Product codes
JDI, KRO
Device Description
The Salvage/Oncology Hip and Total Femur System is designed to replace either the entire femur or a large portion of the proximal femur in cases of severe bone loss most commonly due to oncological diagnoses or limb salvage following multiple revisions or trauma.
When total femoral replacement is indicated, a proximal 1/3 hip component, a diaphyseal shaft and Finn Knee components are necessary. When the device is used for hip replacement, a proximal 1/3 hip component and a femoral stem are required. Two styles of the proximal 1/3 hip component are available, the Letson Modular Proximal and the Finn Proximal Component. Both devices have left and right configurations to ensure proper alignment of components. The proximal 1/3 hip component devices can be used as a modular hip stem with a femoral stem in cases where large proximal femur bone resection is necessary but the knee joint is not involved. The stems compatible with the proximal components are the Finn Knee Modular Segmental Stem Components. The diaphyseal component is a shaft which connects a proximal 1/3 hip component to a knee component when the device is used for total femur replacement.
All components of this system are indicated for use with bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, proximal femur, hip, knee joint
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K9741558
MAR - 4 1998
Summary of Safety and Effectiveness
- Sponsor: Biomet. Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578
Device: Total Femur Replacement
Prosthesis, Hip, semi-constrained, metal/polymer, cemented Classification Name: (888.3350)
Device Description: The Salvage/Oncology Hip and Total Femur System is designed to replace either the entire femur or a large portion of the proximal femur in cases of severe bone loss most commonly due to oncological diagnoses or limb salvage following multiple revisions or trauma.
When total femoral replacement is indicated, a proximal 1/3 hip component, a diaphyseal shaft and Finn Knee components are necessary. When the device is used for hip replacement, a proximal 1/3 hip component and a femoral stem are required. Two styles of the proximal 1/3 hip component are available, the Letson Modular Proximal and the Finn Proximal Component. Both devices have left and right configurations to ensure proper alignment of components. The proximal 1/3 hip component devices can be used as a modular hip stem with a femoral stem in cases where large proximal femur bone resection is necessary but the knee joint is not involved. The stems compatible with the proximal components are the Finn Knee Modular Segmental Stem Components. The diaphyseal component is a shaft which connects a proximal 1/3 hip component to a knee component when the device is used for total femur replacement.
All components of this system are indicated for use with bone cement.
Potential Risks: The potential risks associated with this device are the same as with any ioint replacement device. These include, but are not limited to:
| Reaction to the bone cement | Blood vessel damage | Bone fracture |
|---|---|---|
| Deformity of the joint | Soft tissue imbalance | Infection |
| Cardiovascular disorders | Delayed wound healing | Hematoma |
| Fracture of the cement | Metal sensitivity | Dislocation |
| Implant loosening/migration | Fracture of the components | Excessive wear |
| Breakdown of the porous surface | Tissue growth failure | Nerve damage |
| Dissociation of the components |
Substantially Equivalent Devices: Biomet's Proximal Femoral Hip Replacement 510(k) K810258 cleared 3/5/81; Biomet's Mallory/Head Modular Calcar 510(k) K945115 Cleared Wright Medical Technology's S.O.S. Proximal Femur 510(k) K933281 cleared 5/2/95: 6/7/94
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1998
Ms. Patricia Sandborn Beres Director, Requlatory Affairs Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K974558 Salvage/Oncology Hip and Total Femur System Trade Name: Regulatory Class: ı i Product Codes: JDI and KRO December 3, 1997 Dated: Received: December 5, 1997
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 of the Act. The general controls provisions 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. ਉ substantially equivalent determination assumes compliance with war 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 Sandborn 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 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 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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Page 1_of _1
510(k) Number (if known): K974558
Device Name: Salvage/Oncoloqy Hip and Total Femur System
Indications For Use:
The Salvage/Oncology Hip and Total Femur System is designed to replace the either the encire femur or a large portion of the proximal femur in cases of severe bone loss most commonly due to oncological diagnoses or limb salvage following multiple revisions.
The device requires the use of a modular head, acetabular component and when used as a total femur replacement a Finn Knee tibial component.
All components of this system are indicated for use with bone cement.
(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) | X |
|---|---|
| --------------------------------------- | --- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K974558 (Optional Format 1-2-96) |
|---|---|
| Over-The-Counter Use |