(42 days)
Not Found
No
The description focuses solely on the mechanical design, materials, and surgical application of a hip stem implant. There is no mention of any computational or data-driven components.
Yes
The device, a hip stem, is intended to replace a damaged hip joint and address various degenerative joint diseases and fractures, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is a hip stem replacement, an implant used in surgical procedures to replace damaged hip joints. It is a therapeutic device, not a diagnostic one.
No
The device description clearly describes a metallic femoral stem, which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The provided text describes a surgical implant – a metallic femoral stem designed to be surgically placed within the human body to replace a damaged hip joint.
- Intended Use: The intended use is to be implanted to replace a damaged hip joint. This is a direct surgical intervention, not an in vitro test.
The device is a medical device, specifically a prosthetic implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Biomet's Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem is intended to be implanted to replace a damaged hip joint having large defects in the calcar region as a result of trauma or degenerative disease and in cases where a previous hip replacement component has failed.
This device is a single use implant intended for cemented application.
Biomet's 150mm CoCr BiMetric Head/Neck Replacement Hip Stem – Color Buff Finish Prosthesis is indicated for use in noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; theumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
This device is a single use implant intended for cemented application only.
Product codes (comma separated list FDA assigned to the subject device)
JDI, LZO
Device Description
The device is composed of a metallic femoral stem which is designed to articulate with a commercially available acetabular component. The device limits translation and rotation via the geometry of the articulating surface. There is no linkage across the joint.
Proximally, the stem is designed to replace the proximal portion of the femur in cases of severe bone loss. The medial portion is built up to compensate for bone deficiencies. It is further enhanced by a keel, which allows transfer of the proximal load to the calcar region, and resists torsional forces.
There are suture holes in the lateral flange of the proximal platform for reattaching and securing the greater trochanter in cases where a trochanter osteotomy has been performed.
The platform inside the collar is bead blasted; the stem outside the collar distally has a highly polished surface with a mirror-like appearance (according to Biomet's Color Buff Finish spec Q00999). This surface finish allows for some subsidence of the stem within the cement mantle and decrease the incidence of stem loosening.
A proximal to distal taper of the femoral stem parallels the shape of the femur to follow the natural contours of the canal. The tapered geometry loads the cement mantle in compression and promotes evenly distributed stress off-loading. The employment of a PMMA distal stem positioner centralizes the stem within the canal.
The femoral component utilizes a modular head which is taper-fit onto the stem at the time of surgery. The modular heads are manufactured from wrought cobalt-chromemolybdenum conforming to ASTM F-1537. The stem trunions are identical to Biomet's Type I Tapers for the Zirconia Ceramic Heads cleared in 510(k) K905687. There is a 4 degree included angle on the trunion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, 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)
Not Found
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.
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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.
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
§ 888.3350 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
SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Biomet, Inc.
Airport Industrial Park
Warsaw, Indiana 46580 |
| ---------- | ------------------------------------------------------------------ |
|---|
Device: Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem
Classification Name: Hip joint metal/polymer/metal semi-constrained cemented prosthesis
Intended Use: Biomet's Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem is intended to be implanted to replace a damaged hip joint having large defects in the calcar region as a result of trauma or degenerative disease and in cases where a previous hip replacement component has failed.
This device is a single use implant intended for cemented application.
Device Description: The device is composed of a metallic femoral stem which is designed to articulate with a commercially available acetabular component. The device limits translation and rotation via the geometry of the articulating surface. There is no linkage across the joint.
Proximally, the stem is designed to replace the proximal portion of the femur in cases of severe bone loss. The medial portion is built up to compensate for bone deficiencies. It is further enhanced by a keel, which allows transfer of the proximal load to the calcar region, and resists torsional forces.
There are suture holes in the lateral flange of the proximal platform for reattaching and securing the greater trochanter in cases where a trochanter osteotomy has been performed.
The platform inside the collar is bead blasted; the stem outside the collar distally has a highly polished surface with a mirror-like appearance (according to Biomet's Color Buff Finish spec Q00999). This surface finish allows for some subsidence of the stem within the cement mantle and decrease the incidence of stem loosening.
A proximal to distal taper of the femoral stem parallels the shape of the femur to follow the natural contours of the canal. The tapered geometry loads the cement mantle in compression and promotes evenly distributed stress off-loading. The employment of a PMMA distal stem positioner centralizes the stem within the canal.
The femoral component utilizes a modular head which is taper-fit onto the stem at the time of surgery. The modular heads are manufactured from wrought cobalt-chromemolybdenum conforming to ASTM F-1537. The stem trunions are identical to Biomet's Type I Tapers for the Zirconia Ceramic Heads cleared in 510(k) K905687. There is a 4 degree included angle on the trunion.
1
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Reaction to bone cement Fracture of the components Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Delayed wound healing Fracture of the cement Tissue growth failure
Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Metal sensitivity Dislocation
Substantial Equivalence: In function and overall design Biomet's Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem Prosthesis is equivalent to other commercially available hip prosthesis currently on the market. These devices include:
HNR (Howmedica) Solution (DePuy) Modular Calcar (Zimmer) Bi-Metric CoCr Head Neck Replacement - Grit Blast Finish (Biomet)
Component Listing
Item #
Description
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 DEC
Mr. Fred McClure Requlatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
K983710 Re: 150mm CoCr BiMetric Head/Neck Replacement Trade Name: Hip Stem - Color Buff Finish Requlatory Class: II Product Codes: JDI and LZO October 19, 1998 Dated: October 21, 1998 Received:
Dear Mr. McClure:
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. 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 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.
3
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA assoring of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets premits 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 viero diagnobero at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact ene promotion and (301) 594-4639. Also, please note ene orress of cempitied, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general premation 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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510 (k) Number (if known) : _ K 983710
Device Name: 150mm CoCr BiMetric Head/Neck Replacement Hip Stem - Color Buff Finish
Biomet's 150mm CoCr BiMetric Head/Neck Replacement Hip Stem – Color Indications For Use: Buff Finish Prosthesis is indicated for use in noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; theumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
This device is a single use implant intended for cemented application only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
bidele
(Division Sign Off)
Division of General Restorative Devices
510(k) Number. K983710