(14 days)
Not Found
Not Found
No
The description focuses on the mechanical design and intended use of a hip replacement prosthesis, with no mention of AI or ML technologies.
Yes
The device is a Biomet hip replacement prosthesis, which is used to treat diseased or damaged joints and restore function, aligning with the definition of a therapeutic device.
No
This device, a Biomet hip replacement prosthesis, is a surgically implanted device used to replace a diseased or damaged femoral neck, not for diagnosing conditions.
No
The device description clearly describes a physical implant (femoral stem, modular head) intended for surgical implantation, which is hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states this device is a hip replacement prosthesis, specifically a femoral component. It is a physical implant designed to replace a damaged part of the hip joint.
- Intended Use: The intended uses listed are all related to surgically replacing a diseased or damaged hip joint due to various conditions. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The indications for use for Biomet hip replacement prosthesis include: 1) 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; 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
JDI
Device Description
The Color Buffed Answer Cemented Femorals are designed to replace a diseased or damaged femoral neck. A modular head attaches to a trunion to complete the femoral side of a total hip. The stems indicated for cement use and are distally tapered to provide better stress distribution through the cement mantel. A proximal, lateral flare insures proximal canal filling and a closer match to normal anatomy. A medial collar provides initial stability and prevents components 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 mantel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral neck, hip
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)
Not Found
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
K991987
SUMMARY OF SAFETY AND EFFECTIVENESS
Biomet, Inc Sponsor: Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587
Device: Color Buffed Answer Cemented Femorals
Classification Name: Hip joint metal/polymer semi-constrained cemented prosthesis (CFR 888.3350).
Device Description: The Color Buffed Answer Cemented Femorals are designed to replace a diseased or damaged femoral neck. A modular head attaches to a trunion to complete the femoral side of a total hip. The stems indicated for cement use and are distally tapered to provide better stress distribution through the cement mantel. A proximal, lateral flare insures proximal canal filling and a closer match to normal anatomy. A medial collar provides initial stability and prevents components 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 mantel.
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
Bone fracture Blood vessel damage Soft tissue imbalance Infection Delayed wound healing Hematoma Metal sensitivity Dislocation Fracture of the components Excessive wear Nerve damage
A modification was made to the Answer Femoral Components to produce the Color Buffed Answer Cemented Femorals.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. 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
JUN 28 1999
Ms. Dalene Hufziger Binkley Regulatory Specialist Biomet Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re : K991987 Trade Name: Color Buffed Answer Cemented Femoral Requlatory Class: II Product Code: JDI Dated: June 11, 1999 Received: June 14, 1999
Dear Ms. 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlation (21 CFR Part 820) and that, through periodic (OS) 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.
2
Page 2 % Ms. Dalene H. 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 (301) by 1 your device, please contact the Office of Also, please note the regulation Compliance at (301) 594-4639. entitled, "Misbranding by reference to premarket notification" Other general information on your (21 CFR 807.97). responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.qov/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
Page _ of _
510 (k) NUMBER (IF KNOWN): K991987
DEVICE NAME: Color Buffed Answer Cemented Femoral
INDICATIONS FOR USE:
The indications for use for Biomet hip replacement prosthesis include: 1) I no increations for assnerative 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; 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 | |
|---|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K994987 |