(43 days)
Not Found
No
The summary describes a mechanical implant (screws) for hip replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an implantable screw used for fixation during hip replacement, which is a structural component of a procedure, not a device that directly performs a therapeutic function on its own.
No
The device is described as a screw used for fixation during hip replacement surgery, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a physical implant (titanium screws) used in total hip replacement procedures, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (titanium screws) used to fix an acetabular cup to the pelvic bone during hip replacement surgery.
- Intended Use: The intended use clearly states the device is for surgical procedures and fixation of an implant within the body.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
Intended Use: To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.
Indications for Use: Total hip replacement procedures for:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid 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
- Revision procedures where other treatments have failed
The device is intended for insertion without bone cement. It is a single use implant.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
Biomet Titanium Low Profile Screws are available in 5.0mm and 6.5mm diameters in lengths from 15mm to 70mm. The 5.0mm screws are for use in screw holes on the rim of an acetabular shell whereas the 6.5mm screws are designed for use in the dome of an acetabular shell. Each screw has a self-tapping point.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic bone, acetabular cup, femoral neck, 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
K991807
8 1999 JUL -
Summarv of Safety and Effectivness
Proprietary Name: Titanium Low Profile Screws
Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous, uncemented (888.3358) Device Product Code: 87LPH
Intended Use: To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.
Indications for Use: Total hip replacement procedures for:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis 1)
- Rheumatoid arthritis 2)
- Correction of functional deformity 3)
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with 4) head involvement, unmanageable using other techniques
- Revision procedures where other treatments have failed 5)
The device is intended for insertion without bone cement. It is a single use implant.
Device Description: Biomet Titanium Low Profile Screws are available in 5.0mm and 6.5mm diameters in lengths from 15mm to 70mm. The 5.0mm screws are for use in screw holes on the rim of an acetabular shell whereas the 6.5mm screws are designed for use in the dome of an acetabular shell. Each screw has a self-tapping point.
Substantial Equivalence: Biomet's Low Profile Screws are substantially equivalent to acetabular screws depicted with the following competitive acetabular systems:
Trilogy Acetabular System - Zimmer Arthopor Acetabular System - Joint Medical Products Corp.
Potential Risks: The potential risks associated with this device are the same as other metallic implants. These include, but are not limited to:
Blood vessel damage Bone fracture Soft tissue imbalance Infection Delaved wound healing Hematoma Implant loosening Implant fracture Dissassociation of components Excessive wear Deformity of the joint Cardiovascular disorders Metal sensitivity Implant migration Nerve damage
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human profiles in a row, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 8 1999
Patricia Sandborn Beres Director, Regulatory Affairs Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
K991807 Re:
Trade Name: Titanium Low Profile Acetabular Screws Regulatory Class: II Product Code: LPH Dated: May 24, 1999 Received: May 26, 1999
Dear Ms. Beres:
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.
2
Page 2 - Ms. Patricia Sandborn Beres
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
3
510(k) Number (if known): K99)807
Device Name: Titanium Low Profile Screws
Indications For Use: Total hip replacement procedures for:
- Noninflammatory degenerative joint disease including osteoarthritis 1) and avascular necrosis
-
- Rheumatoid arthritis
- Correction of functional deformity 3)
- Treatment of non-union, femoral neck fracture, and trochanteric 4) fractures of the proximal femur with head involvement, unmanageable using other techniques
- Revision procedures where other treatments have failed 5)
The devices are single use implants.
Intended Use: To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.
(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Division of General Restorative Devices K991807
510(k) Number