(18 days)
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No
The document describes a traditional hip replacement prosthesis and does not mention any AI or ML capabilities in its intended use, device description, or performance studies.
Yes
The device is a hip replacement prosthesis, which is designed to replace diseased or damaged anatomical structures and restore function, thereby treating or alleviating a disease or injury.
No
The provided text describes a hip replacement prosthesis used for treatment, not for identifying or diagnosing a disease or condition.
No
The device description clearly describes a physical implant (femoral stem) and its components, intended for surgical implantation. It is a hardware device, not software.
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 testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a hip replacement prosthesis, which is an implantable medical device used to replace a damaged or diseased joint within the body. Its function is mechanical and structural, not diagnostic testing of bodily fluids or tissues.
The device's purpose is to treat conditions affecting the hip joint through surgical implantation, not to diagnose those conditions through laboratory testing.
N/A
Intended Use / Indications for Use
The indications for use for Biomet hip replacement prosthesis include: 1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) treatment of non-union, femoral neck fracture, and throchanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) revisions of hip replacement components.
Standard surgical and rehabilitative procedures are indicted with this device.
This device is for use with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JDI
Device Description
The Color Buffed Cemented Femorals are designed to replace a diseased or damaged femoral neck. A modular head attaches to trunion to complete the femoral side of a total hip. The stems are indicated for cement use and are distally tapered to provide better stress distribution through the cement mantle. A reduced superior lateral insures easier insertion while maintaining proximal canal filling. A reduced medial collar provides greater range of motion, stability, and prevention of component subsidence. Each stem is straight, thus eliminating the need for a left and right configurations. The stems utilize a modular head to provide an articulating surface with any commercially available acetabular component. These components are intended for use with bone cement, and as such. have PMMA spacers added to the stem to enhance stability within the cement mantle.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
femoral neck, hip
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor: Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587
Contact: Dalene Hufziger Binkley (219) 372-1612
Trade Name: Color Buffed Cemented Femoral
Classification Name: Hip joint metal/polymer semi-constrained cemented prosthesis (CFR 888.3350).
Device Description: The Color Buffed Cemented Femorals are designed to replace a diseased or damaged femoral neck. A modular head attaches to trunion to complete the femoral side of a total hip. The stems are indicated for cement use and are distally tapered to provide better stress distribution through the cement mantle. A reduced superior lateral insures easier insertion while maintaining proximal canal filling. A reduced medial collar provides greater range of motion, stability, and prevention of component subsidence. Each stem is straight, thus eliminating the need for a left and right configurations. The stems utilize a modular head to provide an articulating surface with any commercially available acetabular component. These components are intended for use with bone cement, and as such. have PMMA spacers added to the stem to enhance stability within the cement mantle.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but not limited to:
Reaction to bone cement Deformity of the joint Cardiovascular diseases Fracture of the cement Implant loosening/Migration Tissue growth failure
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Nerve damage
Bone fracture Infection Hematoma Dislocation Excessive wear
Modifications were made to the Answer Femoral Component to produce the Color Buffed Cemented Femoral.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three people, one behind the other, with their arms raised. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 1999
Ms. Dalene Hufziger Binkley Biomet, Inc. P.O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587
Re: K992903 Trade Name: Color Buffed Cemented Femoral Regulatory Class: II Product Code: JDI Dated: August 19, 1999 Received: August 30, 1999
Dear Ms. Hufziger Binkley:
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 Regulations, Title 21, Parts 800 to 895. A 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 action. In addition, FDA may publish further announcements 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. Dalene Hufziger Binkley
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 tollfree number (800) 638-2041 or at (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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510 (k) NUMBER (IF KNOWN): __
DEVICE NAME: Color Buffed Cemented Femoral
INDICATIONS FOR USE:
The indications for use for Biomet hip replacement prosthesis include: 1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) treatment of non-union, femoral neck fracture, and throchanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) revisions of hip replacement components.
Standard surgical and rehabilitative procedures are indicted with this device.
This device is 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 | X | OR | Over-The-Counter-Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | ||
| (Division Sigr. Off, | |||
| Div eral Restorative Devices | |||
| 510(k) Number | K992903 | 000005 |