(13 days)
The Bi-Metric CoCr Head/Neck Replacement Hip Stem is intended for use in cases with a diagnoses of:
a) Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
b) Rheumatoid arthritis
c) Correction of functional deformities
d) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
e) Revisions of hip replacement components
The Bi-Metric CoCr Head/Neck Replacement Hip Stem is intended for cemented application and is a single use device.
The Bi-Metric CoCr Head/Neck Replacement Hip Stem is a cobalt alloy (Co-Cr-Mo) femoral stem which is designed to articulate with a commercially available acetabular component. It has no linkage across the joint. The medial portion is built up to compensate for bone of severe bone loss. It is further enhanced by a keel, which allows transfer of the proximal load to the calcar region, and resists torsion. There are suture holes in the lateral flange of the proximal platform for reattaching and securing the greater trochanter in cases where a trochanteric osteotomy is needed. The platform inside the collar is "bead blasted"; the stem outside the collar distally is "grit blasted" providing for an improved fixation between the stem/cement interface.
There are three resection levels: 34mm, 45mm, and 55mm with four diameters: 9mm, 11mm, 13, and 15mm. The stems are available in 150mm, 200mm, and 250mm lengths. The 150mm and 200mm stems are straight and the 250mm stems are bowed right and left specific.
The provided text is a 510(k) summary for the Bi-Metric CoCr Head/Neck Replacement Hip Stem. It describes the device, its intended use, potential risks, and a claim of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, any study proving the device meets those criteria, or details regarding test sets, ground truth establishment, or human reader performance.
The document focuses on regulatory approval based on substantial equivalence, implying that the device's safety and effectiveness are established by its similarity to an already approved device rather than through novel performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The following points represent the absence of this information in the provided document:
- A table of acceptance criteria and the reported device performance: Not available. The document does not define specific acceptance criteria for performance; instead, it relies on substantial equivalence.
- Sample size used for the test set and the data provenance: Not available. No performance studies are described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No performance studies are described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available. No performance studies are described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a hip stem, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hip stem.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available. No performance studies are described.
- The sample size for the training set: Not applicable. This device is a hip stem, not an AI model.
- How the ground truth for the training set was established: Not applicable. This device is a hip stem, not an AI model.
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K992058
1
SUMMARY OF SAFETY AND EFFECTIVENESS
Biomet , Inc. Submitter: Airport Industrial Park P.O. Box 587 Warsaw, Indiana 4681-0587
Contact Person: Mary L. Verstynen
Product Code: 87JDI
Bi-Metric CoCr Head/Neck Replacement Hip Stems Device Name:
INTENDED USE: The Bi-Metric CoCr Head/Neck Replacement Hip Stem is
In the Bi-Metric Cock and consess of intended for use in cases with a diagnoses of:
- ded for use in cases with a diagnoses on.
a) Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis - b) Rheumatoid arthritis
- c) Correction of functional deformities
- c) Correction of nunchonial delofinities
d) Treatment of non-union, femoral neck fracture, and trochanteric fractures of I reatment of non-unfon, remoral nock trav, inmanageable using other techniques - e) Revisions of hip replacement components
The Bi-Metric CoCr Head/Neck Replacement Hip Stem is intended for cemented application and is a single use device.
DEVICE DESCRIPTION: The Bi-Metric CoCr Head/Neck Replacement Hip Stem
Comment of the first and ish in and ish is designed to articulate with a DEVICE DESCRIPTION. The Di-Moral stem which is designed to articulate with a
is a cobalt alloy (Co-Cr-Mo) femoral stem who it has no linkage across the ioint is a cobait anoy (Co-CI-MO) Temoral stom was It has no linkage across the joint.
commercially available acetabular component. It has no linkage across the femur in commercially available acclabular component "It is as semperate for bone of severe bone loss. The medial portion is built up to compensate for bone of severe bone foss. The medial portion is at , which allows transfer of the proximal
deficiencies. It is further enhanced by a keel, which There ene suture holes in the deficiencies. It is further cimanced by a novel forces. There are suture holes in the load to the calcal region, and resists tornemartaching and securing the greater iateral flange of the proximal platform for readed. The platformed. The platform trochanter in cases where a trochants oscoconty the scollar distally is "grit blasted"
inside the collar is "bead blasted"; the stem outside the consimproved fixation mside the conal IS "bead blasted", the clear or viding for an improved fixation between the stem/cement interface.
There are three resection levels: 34mm, 45mm, and 55mm with four diameters: 9mm, I here are three resection levels: 3-milli, 150mm, 200mm, 200mm, and 250mm
11mm, 13, and 15mm. The stems are available in 150mm, steres are boxec I Irmin, 15, and 1511m. The stems are straight and the 250mm stems are bowed right and left specific.
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POTENTIAL RISKS: The potential risks associated with this device are the same as with any joint replacement. These include, but are limited to:
Fracture of the component Deformity of the joint Bone fracture Hematoma Implant loosening/migration Delayed wound healing Blood vessel damage Infection Breakdown of porous surface Soft tissue imbalance Metal sensitivity Nerve damage Cardiovascular disorders Tissue growth failure Excessive wear Dislocation
SUBSTANIAL EQUIVALENCE: The Bi-Metric CoCr Head/Neck Replacement Hip Stem is substantially equivalent to the following predicate device in terms of indications, intended use, design, and material.
Predicate device: Bi-Metric CoCr Head/Neck Replacement Hip Stem, K955350
000016
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are meant to represent the flow of people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Ms. Mary L. Verstynen Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587
K992058 Re:
Trade Name: Bi-Metric CoCr Head/Neck Replacement System Regulatory Class: II Product Code: JDI Dated: June 15, 1999 Received: June 18, 1999
Dear Ms. Verstynen:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your Boonon 3 re(x) reasustantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the Energismer) to device Amendments, or to devices that have been reclassified in enacinem date of the Medical Dories I Level, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, manov the Act include requirements for annual registration, listing of devices, Controlis of the rest ree, 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 (Fremarket Approvat), it may be subject to sacklerial resultations, 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 mopononist 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 scotions 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. Mary Verstynen
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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of Page
510(k) NUMBER (IF KNOWN): __ K992058
DEVICE NAME: Bi-Metric CoCr Head/Neck Replacement Hip Stem
INDICATIONS FOR USE:
The Bi-Metric CoCr Head/Neck Replacement IIip Stem is intended for use in cases with a diagnoses of:
- s Non-inflammatory degenerative joint disease, including osteoarthritis and avascular a) necrosis
- Rheumatoid arthritis b)
- Correction of functional deformities c)
- Correction of non-union, femoral neck fracture, and trochanteric fractures of the d) proximal femur with head involvement, unmanageable using other techniques
- Revisions of hip replacement components e)
The Bi-Metric CoCr Head/Neck Replacement Hip Stem is intended for cemented application and is a single use device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
(Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) OR
Over- The- Counter-(Optional Format 1-2 વ્વીર
(Optional Format 1-10)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K99208
00004
3
§ 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.