(22 days)
Not Found
No
The summary describes a mechanical implant with no mention of software, algorithms, or any AI/ML related terms or concepts.
Yes
The device is a femoral component for knee replacement, which is a surgical procedure to treat painful and disabled knee joints, correcting deformities and revising unsuccessful prior procedures. This directly addresses medical conditions to restore function, meeting the definition of a therapeutic device.
No
This device is a femoral component for knee replacement surgery, indicated for treating painful and disabled knee joints. Its function is to replace part of the knee, not to diagnose a condition.
No
The device description clearly states the device is a physical component made of Co-Cr-Mo, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a Maxim® RPG PS Femoral Component, which is a surgical implant used to replace a damaged knee joint. It is a physical device implanted into the body.
- Intended Use: The intended use clearly states it's for treating painful and disabled knee joints, correcting deformities, and revising previous procedures. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
The information provided describes a medical device used in surgery, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Maxim® RPG PS Femoral Component is indicated for:
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- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is intended for use with bone cement.
Product codes
JWH
Device Description
The Maxim® RPG PS Femoral Components are composed of Co-Cr-Mo. The posterior stabilized femoral components provide posterior femoral rollback via a femoral cam that articulates with a polyethylene post on the tibial component. The minor modifications made were to the trochlear groove, and PS Box.
There are three sizes available in both right and left configurations for the Maxim® RPG PS Femoral Components. The anatomic component design allows the surgeon to reconstruct the anatomic dimensions and kinematics of the natural femur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee joint
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
Non-Clinical Testing: Mechanical analysis was completed to determine substantial equivalence.
Clinical Testing: Clinical testing was not used to determine substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Legally Marketed Device to which Substantial Equivalence is Claimed: Maxim® PS Femoral Component
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in a bold, stylized font with a thick black outline. Below the logo, the words "CORPORATE HEADQUARTERS" are written in a smaller, thinner font.
SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant or Sponsor:
Biomet. Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Contact Person:
Michelle L. McKinley Regulatory Specialist
Proprietary Name: Maxim® RPG PS Femoral Component
Common or Usual Name: femoral knee component
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis (CFR 888.3560)
Device Classification: Class II
Device Product Code: 888.3560
Legally Marketed Device to which Substantial Equivalence is Claimed: Maxim® PS Femoral Component
Device Description:
The Maxim® RPG PS Femoral Components are composed of Co-Cr-Mo. The posterior stabilized femoral components provide posterior femoral rollback via a femoral cam that articulates with a polyethylene post on the tibial component. The minor modifications made were to the trochlear groove, and PS Box.
There are three sizes available in both right and left configurations for the Maxim® RPG PS Femoral Components. The anatomic component design allows the surgeon to reconstruct the anatomic dimensions and kinematics of the natural femur.
Intended Use:
The Maxim® RPG PS Femoral Component is indicated for:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where on or more compartments are involved.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where on or more compartments are involved.
E
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
.
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@hiomet.com
1
Image /page/1/Picture/0 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in a bold, stylized font. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, sans-serif font. The text is black and the background is white.
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is intended for use with bone cement.
Summary of Technologies: In terms of overall design, including geometry, materials, and fixation enhancements, as well as intended use, the Maxim® RPG PS Femoral Component is equivalent to the predicate device. Minor changes were made to the predicate femoral component.
Non-Clinical Testing: Mechanical analysis was completed to determine substantial equivalence.
Clinical Testing: Clinical testing was not used to determine substantial equivalence.
Maxim® is a registered trademark of Biomet,Inc.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
에
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
OFFICE 219.267.6639
ドヘメ 219.267.81300087
E-MAIL . biomet@biomet.com
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Public Health Service
AUG 1 5 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Michelle L. McKinley Regulatory Specialist Biomet Inc. P.O. Box 587 Warsaw, Indiana 46581
Re: K012348
Trade Name: Maxim® RPG PS Femoral Component Regulation Number: 888.3560 Regulatory Class: II Product Code: JWH Dated: July 7, 2000 Received: August 4, 2000
Dear Ms. McKinley:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Section 510(x) flouintially equivalent (for the indications for use to May 28, 1076, the above and we nave determined the devices marketed in interstate commerce provinces has needsessified in stated in the eliebourcy to device Amendments, or to devices that have been reclassified in your cou enactifield date of the Medical Dovice Parlena. Food, Drug, and Cosmetic Act (Act). You mays accordance with the provisions of the reachers' rood, of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, controls provisions or the neater request required in the misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into such additional controls. Existing major regulations (Premarket Approval), it may of subject to oder as a subteral Regulations, Title 21, Parts 800 to 895. allecting your device can or round nation assumes compliance with the current Good A Substantally oquirvatent downent, as set forth in the Quality System Regulation (QS) for Manufacturing I ractio regulation (21 CFR Part 820) and that, through periodic (QS) Medical Devices. General regulation (FDA) will verify such assumptions. Fallure to inspections, the rood and Drug Nammouties (1 x 2 x 1 x 1 x addition, FDA may publish contply with the GMI Tegatation into readeral Register. Please note: this response to your premarks contonting your submission does not affect any obligation you might It spollse to your promative no in 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) prematet notification. The FDA finding of substantial equivalence of your device to a legally marketed nontication. The I Driving of succion for your device and thus, permits your device to proceed to the market.
3
Page 2 - Dr. Walter Abendschein
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire spoentle arriver diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (201) 594-1639. Traditional (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 mormation on Jour rope at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Amplellestonfor
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
4
510(k) Number (if known):
Device Name: Maxim® RPG PS Femoral Component
Indications for Use:
The Maxim® RPG PS Femoral Component is indicated for:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is intended for use with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE OF ANOTHER PAGE IS NEEDED)
Brmhheurofmann
Division Sign Off
Division of General, Restorative and Neurological Devic
510(k) Number K012348