(103 days)
Not Found
No
The document describes a bone cement and does not mention any AI or ML capabilities.
Yes
The device is a bone cement used in arthroplasty procedures to fix prosthetic parts to living bone, aiming to reconstruct and restore function to joints affected by infection, which constitutes the treatment of a disease or injury.
No
The device is a bone cement used in arthroplasty procedures to fix prosthetic parts to bone. Its function is mechanical and therapeutic, not to diagnose a condition.
No
The device description clearly states it is a bone cement, which is a physical material, not software.
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.
- Cobalt™ MV with Gentamicin Bone Cement: This device is a bone cement used during surgery to fix prosthetic parts to bone. It is implanted directly into the body and does not involve the analysis of specimens taken from the body.
The description clearly indicates its use in surgical procedures for joint replacement, which is an in vivo (within the living body) application, not an in vitro (in glass/outside the living body) diagnostic test.
N/A
Intended Use / Indications for Use
Intended Use: Cobalt™ G-MV Bone Cement is an acrylic cement-like substance which allows seating and fixation of the prosthesis to the bone. After complete polymerization, the cement acts as a buffer for even weight distribution and other stresses between the prosthesis and the bone.
Indications for Use: Cobalt™ G-MV Bone Cement is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.
Cobalt™ MV with Gentamicin Bone Cement is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.
Product codes
MBB, LOD
Device Description
Cobalt™ G-MV Bone Cement is a methyl methacrylate-styrene copolymer based acrylic medium viscosity bone cement with gentamicin. Cobalt™ G-MV Bone Cement provides two separate, premeasured sterilized components that when mixed form rapidly-setting radiopague bone cement for use in orthopedic surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
hip, knee and other joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
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Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with a geometric design. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.
OCT 2 7 2009
510(k) Summary
Preparation Date: July 15, 2009
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Susan Alexander
Proprietary Name: Cobalt™ MV with Gentamicin Bone Cement (also known as Cobalt™ G-MV)
Common Name: PMMA Bone Cement
Classification Name: Polymethylmethacrylate (PMMA) Bone Cement (21 CFR &888.3027)
Product Code: MBB (bone cement, antibiotic), LOD (bone cement)
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
| Cobalt™ G-HV Bone Cement | K051532 | Biomet Manufacturing Corp. |
|---|---|---|
| Simplex® P with Tobramycin Bone Cement | K014199 | Stryker Howmedica Osteonics |
'Device Description: Cobalt™ G-MV Bone Cement is a methyl methacrylate-styrene copolymer based acrylic medium viscosity bone cement with gentamicin. Cobalt™ G-MV Bone Cement provides two separate, premeasured sterilized components that when mixed form rapidly-setting radiopague bone cement for use in orthopedic surgery,
Intended Use: Cobalt™ G-MV Bone Cement is an acrylic cement-like substance which allows seating and fixation of the prosthesis to the bone. After complete polymerization, the cement acts as a buffer for even weight distribution and other stresses between the prosthesis and the bone.
Indications for Use: Cobalt™ G-MV Bone Cement is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.
Summary of Technologies: The technological characteristics of Cobalt™ G-MV Bone Cement are the same as, or similar to, the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc. unless otherwise noted. Simplex® is a registered trademark of Stryker Howmedica Osteonics.
Mailing Address: PO Box 587 Warsaw, IN 48681-0587 Toll Free: 800 348 9500 Office: 574 267 6639 Man Fax: 574 267 8137 www.bjomel com
Shipping Address: Sit Fast Boll Britte Warsaw, IN 46562
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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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design. The logo is commonly used on official documents and materials related to the department.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Biomet, Inc. % Ms. Susan Alexander 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581
OCT 2 7 2009
Re: K092150
Trade/Device Name: Cobalt™ MV with Gentamicin (aka Cobalt™ G-MV) Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD, MBB Dated: October 7, 2009 Received: October 8, 2009
Dear Ms. Alexander:
We have reviewed your Scction 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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Susan Alexander
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N Millerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Cobalt™ MV with Gentamicin (aka Cobalt™ G-MV) Bone Cement
Indications For Use:
Cobalt™ MV with Gentamicin Bone Cement is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Diysion Sign-Off) Division of Surgical, Offhopedic. and Restorative Devices
510(k) Number K092150
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