(79 days)
Not Found
No
The summary describes a mechanical hip implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a hip replacement component, indicated for treating various debilitating hip conditions, thus restoring function and alleviating symptoms.
No
The provided text describes an artificial hip component intended for implantation to treat various hip conditions, not to diagnose them. It's a therapeutic device, not a diagnostic one.
No
The device description clearly describes a physical implantable medical device (femoral component for hip replacement) made of materials like titanium and cobalt-chromium-molybdenum, intended for surgical implantation. There is no mention of software as the primary or sole component.
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. These tests are performed outside of the body.
- Device Description: The provided text describes a Lateralized Integral Hip Component, which is a surgical implant used in hip replacement procedures. It is a physical device implanted inside the body to replace a damaged hip joint.
- Intended Use: The intended use clearly states it is for hip replacement and revision procedures, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a surgical intervention, 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 Lateralized Integral Hip Component are the same as with any other hip replacement, namely:
- a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- b.) rheumatoid arthritis
- c.) correction of functional deformity
- d.) revision procedures where other treatments or devices have failed
e.) treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
The Lateralized Integral Hip Component is intended for press-fit application and single use implantation.
Product codes (comma separated list FDA assigned to the subject device)
87LPH, JDI
Device Description
The Lateralized Integral Hip Component is an evolution of Biomet's successful BiMetric family. The lateralizion is achieved by moving the trunion/taper 6-mm medially, thereby moving the axis of rotation 6-mm lateral. The horizontal offset of the femoral neck addresses the need to increase joint stability by tensioning the soft tissue. The same design is employed on the Lateralized Taperloc, another of Biomet's stems.
The proximal geomerry of the Integral femoral component is designed to promote distal filling of the metaphysis. A porous coated duckbill collar is incorporated to provide stability and stress transfer. This helps to provide rotational stability and facilitates potential ingrowth and load transfer.
The proximal to distal taper of the femoral stem parallels the shape of the femur canal, allowing a gradual decrease in the stresses transferred to the bone from proximal to distal.
The 3-degree compound proximal to distal taper helps the device to achieve exceptional fit. The stems are proportionally sized and shaped 9- mm to 19-mm diameters in 1-mm increments, and from 125 to 175 mm in length in 5 increments. The straight stem design of the primary component eliminates the need for a left or right configurations.
The femoral component utilizes a modular head, which is taper-fit on to the stem at the time of surgery. The modular head is manufactured from wrought titanium or cobaltchromium-molybdenum conforming to ASTM F-620 and F-1537 respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, 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.
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.
Not Found
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
2/18/99
Image /page/0/Picture/4 description: The image shows a handwritten alphanumeric string. The string is "K984296". The characters are written in a cursive style with black ink on a white background.
SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR:
Biomet, inc. P.O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587
CONTACT PERSON:
Dalene Hufziger Binkley
Lateralized Integral Hip Component DEVICE NAME:
CLASSIFICATION NAME: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. §888.3350
DEVICE PRODUCT CODE: 87LPH
CLASSIFICATION TYPE: П
INTENDED USE: The indications for Lateralized Integral Hip Component are the same as with any other hip replacement, namely:
- a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- b.) rheumatoid arthritis
- c.) correction of functional deformity
- d.) revision procedures where other treatments or devices have failed
e.) treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
The Lateralized Integral Hip Component is intended for press-fit application and single use implantation.
DEVICE DESCRIPTION: The Lateralized Integral Hip Component is an evolution of Biomet's successful BiMetric family. The lateralizion is achieved by moving the trunion/taper 6-mm medially, thereby moving the axis of rotation 6-mm lateral. The horizontal offset of the femoral neck addresses the need to increase joint stability by tensioning the soft tissue. The same design is employed on the Lateralized Taperloc, another of Biomet's stems.
The proximal geomerry of the Integral femoral component is designed to promote distal filling of the metaphysis. A porous coated duckbill collar is incorporated to provide stability and stress transfer. This helps to provide rotational stability and facilitates potential ingrowth and load transfer.
The proximal to distal taper of the femoral stem parallels the shape of the femur canal, allowing a gradual decrease in the stresses transferred to the bone from proximal to distal.
1
The 3-degree compound proximal to distal taper helps the device to achieve exceptional fit. The stems are proportionally sized and shaped 9- mm to 19-mm diameters in 1-mm increments, and from 125 to 175 mm in length in 5 increments. The straight stem design of the primary component eliminates the need for a left or right configurations.
The femoral component utilizes a modular head, which is taper-fit on to the stem at the time of surgery. The modular head is manufactured from wrought titanium or cobaltchromium-molybdenum conforming to ASTM F-620 and F-1537 respectively.
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:
| Fracture of the component | Bone fracture |
|---|---|
| Cardiovascular disorders | Hematoma |
| Implant loosening/migration | Blood vessel damage |
| Soft tissue imbalance | Nerve damage |
| Deformity of the joint | Excessive wear |
| Tissue growth failure | Infection |
| Delayed wound healing | Dislocation |
| Metal sensitivity | Breakdown of the porous surface |
SUBSTANTIAL EQUIVALENCE: The Lateralized Integral fernoral component is similar to most femoral component on the market today in terms of overall intended function and design. Direct comparison was made with the following predicates:
| Biomet Integral Primary Porous | K921225 |
|---|---|
| Biomet Lateralized Taperloc Hip System | K921301 |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1999
Ms. Dalene Hufziger Binkley Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
K984296 Re: Lateralized Integral Hip Component Trade Name: Regulatory Class: II Product Codes: LPH and JDI Dated: November 23, 1998 Received: December 1, 1998
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 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 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 requlations.
3
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 labelinq 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.qov/cdrh/dsmamain.html".
Sincerely yours,
n Cella 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 / of /
510(K) NUMBER IF KNOWN: DEVICE NAME: Lateralized Integral Hip Stem
The indications for use are:
- a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- b.) rheumatoid arthritis
- c.) correction of functional deformities
- d.) revisions procedures where other devices or treatments have failed
- e.) treatment of non-unions, femoral neck trochanteric fractures of the proximal femur with neck involvement, unmanageable using other techniques
The Lateralized Integral Hip Stem is intended for press-fit application and is for single use implantation.
(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)
Over the Counter-Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices 4984296
510(k) Number