(30 days)
Not Found
No
The summary describes a patient-matched implant (PMI) based on anatomical parameters, but there is no mention of AI or ML being used in the design or manufacturing process. The modifications are based on "common parameters modified" and fitting within a defined "envelope," suggesting a more traditional design approach.
Yes
The device is a hip stem used in primary hip replacement surgery, which is a therapeutic intervention for degenerative joint disease.
No
The document describes a hip stem used for primary hip replacement surgery, which is a therapeutic device. It does not describe any functions related to diagnosing a condition.
No
The device description clearly describes a physical hip stem implant, which is a hardware component. The modifications mentioned are to the physical dimensions and shape of this implant.
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 is a hip stem, which is an implantable device used in hip replacement surgery. It is a physical component inserted into the patient's body.
- Intended Use: The intended use is for primary hip replacement surgery, which is a surgical procedure, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative ioint disease.
Product codes
LPH, MEH
Device Description
A surgeon will request a PMI hip stem over a standard line product in order to better fill the patient's natural femoral canal. The most common parameters modified include the expansion of the A-P diameter, the increase of the lateral flare of the device and the posterior bowing of the stem. The resulting device will more closely match the patient's natural anatomy. Since each stem is matched to a particular patient, a specific device description is unavailable. Instead, an envelope has been defined which all devices must fit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature patients
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
Non-Clinical Testing: Mechanical testing and engineering analysis has justified the modifications to this device.
Clinical Testing: None provided
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
BIOMET
Summary of Safety and Effectiveness
Applicant/Sponsor:Biomet Orthopedics, Inc.
FEB 0 5 2003
Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist
Proprietary Name: HA PMI Femoral Hip Stem
Common Name: Hip replacement prosthesis
Classification Name: Hip ioint metal/polmer/metal semi-constrained, porouscoated, uncemented prosthesis (21 C.F.R. 888.3358)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The PMI Hip Femoral - 510(k) K923452.
Device Description: A surgeon will request a PMI hip stem over a standard line product in order to better fill the patient's natural femoral canal. The most common parameters modified include the expansion of the A-P diameter, the increase of the lateral flare of the device and the posterior bowing of the stem. The resulting device will more closely match the patient's natural anatomy. Since each stem is matched to a particular patient, a specific device description is unavailable. Instead, an envelope has been defined which all devices must fit.
Intended Use: Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative ioint disease.
Summary of Technologies: The HA PMI Hip Femoral Stems are similar to or identical in materials, design, sizing and processing to the predicate device.
Non-Clinical Testing: Mechanical testing and engineering analysis has justified the modifications to this device.
Clinical Testing: None provided
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
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OFFICE 574.267.6639
FAX 574.267.8137
E-MAIL biomet@biomet.com
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2003
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K030048
Trade/Device Name: HA PMI Femoral Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Codes: LPH, MEH Dated: January 2, 2003 Received: January 6, 2003
Dear Ms. Beres:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality
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Page 2 - Ms. Patricia Sandborn Beres
systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely, yours,
Mark N. Milkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: HA PMI Hip Femoral Stems
Indications For Use:
Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.
Mark A. Milkerso
Division Sis 2 % 31 Restorative and Neur
510(k) Number -
(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)
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