(59 days)
P810020, K993836
Not Found
No
The summary describes a bone cement and its physical properties, with no mention of AI or ML.
No.
The device is a bone cement used to fix prosthetic parts to bone, which is a supportive and structural material rather than a therapeutic agent.
No
Explanation: The device is Cobalt™ HV Bone Cement, indicated for use as bone cement in arthroplasty procedures to fix prosthetic parts to bone. Its purpose is to physically secure components, not to diagnose a medical condition.
No
The device description clearly states it is a bone cement formed by mixing two components, indicating it is a physical material, not software. The performance studies also focus on the material properties of the cement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used as bone cement in surgical procedures (arthroplasty) to fix prosthetic parts to bone. This is a therapeutic and structural application within the body.
- Device Description: The description confirms it's a material that is mixed and sets to form bone cement.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to test blood, urine, tissue, etc., to detect diseases, conditions, or measure substances.
The information provided describes a medical device used in vivo (within the body) for surgical fixation, not an in vitro (outside the body) diagnostic test.
N/A
Intended Use / Indications for Use
Cobalt™ Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.
Product codes
LOD
Device Description
Cobalt™ Bone Cement provides two separate, pre-measured sterilized components which when mixed form radiopaque rapidly setting bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, knee and other joints, 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
Extensive in-vitro testing was performed in accordance with Class II Special Controls Guidance: Polymethylmethacrvlate (PMMA) Bone Cement: Guidance for Industry & FDA-July 17, 2002 to demonstrate the equivalence of Cobalt™ Bone Cement to Palacos® R Bone Cement. Test results showed that the technological characteristics (mechanical, chemical, physical & handling properties) of the two cements are substantially the same. The substantial equivalence of Cobalt™ Bone Cement to Palacos® R Bone Cement was determined by performing comparative in vitro testing and then comparing the results. The results showed that Cobalt™ Bone Cement possesses mechanical, chemical, physical and handling characteristics necessary to fulfill its intended use. No clinical testing was performed.
Key Metrics
Not Found
Predicate Device(s)
PMA (P810020, S001, S002, S003, S004), K993836
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.”
0
AUG 4 - 2005
510(k) Summary
Cobalt™ HV Bone Cement
Applicant/Sponsor: Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587
Contact Person: Lonnie Witham Telephone: (574) 267-6639 Fax: (574) 372-1683
Proprietary Name: Cobalt™ HV Bone Cement
Common Name: Bone Cement
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Device: Palacos® R Bone Cement Approved by: PMA (P810020, S001, S002, S003, S004) reclassified into Class II Manufacturer: Biomet Inc.; 56 East Bell Drive; Warsaw, IN 46582
Predicate Device: Generation 4® Bone Cement Cleared by: 510(k) Notification (K993836) Manufacturer: Biomet Inc.; 56 East Bell Drive; Warsaw, IN 46582 (Relevant to packaging and sterilization processes cleared for this device)
Device Description:
Cobalt™ Bone Cement provides two separate, pre-measured sterilized components which when mixed form radiopaque rapidly setting bone cement.
Materials used:
40 g powder component (copolymer):
- Methylmethacrylate-methylacrylate copolymer containing FD&C Blue No. 2 . Aluminum Lake
- Benzoyl peroxide, hydrous 75% .
- Zirconium dioxide .
20 ml of liquid component (monomer):
- Methylmethacrylate (stabilized with hydroquinone) .
- . N.N-dimethyl-p-toluidine
Methymethacrylate monomer is the primary constituent of the liquid component. In much smaller quantities are the accelerator, N, N-dimethyl-p-toluidine, and the stabilizer, hydroquinone, both are typical constituents of PMMA bone cement.
1
When the powder and liquid components are mixed, the accelerator speeds the generation of free radicals and the stabilizer in the liquid reacts with many of the early free radicals, but is soon consumed. Free radicals can then initiate formation of polymer chains.
Polymerization proceeds slowly over the first few minutes. Polymer chains at the surface of the powder beads mingle with monomer and newly formed polymer chains, while smaller beads may dissolve completely. The cement temperature rises as set time of the cement approaches. Polymerization is essentially complete and the bone cement is hard within 15 minutes.
Intended Use / Indications for Use:
Cobalt™ Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.
Summary of the Technological Characteristics:
Extensive in-vitro testing was performed in accordance with Class II Special Controls Guidance: Polymethylmethacrvlate (PMMA) Bone Cement: Guidance for Industry & FDA-July 17, 2002 to demonstrate the equivalence of Cobalt™ Bone Cement to Palacos® R Bone Cement. Test results showed that the technological characteristics (mechanical, chemical, physical & handling properties) of the two cements are substantially the same.
Non-Clinical:
The substantial equivalence of Cobalt™ Bone Cement to Palacos® R Bone Cement was determined by performing comparative in vitro testing and then comparing the results. The results showed that Cobalt™ Bone Cement possesses mechanical, chemical, physical and handling characteristics necessary to fulfill its intended use. In summary, Cobalt™ Bone Cement is substantially equivalent to Palacos® R Bone Cement for its primary intended use of fixation of prosthetic components as described in the device labeling. No clinical testing was performed.
Clinical Testing: No clinical testing was required.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
9200 Corpor
Rockville M
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lonnie Witham Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 6581-0587
Re: K051496
Trade/Device Name: Cobalt™ HV Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: June 3, 2005 Received: June 6, 2005
Dear Mr. Witham:
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.
AUG 4 - 2005
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 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.
3
Page 2 -- Mr. Lonnie Witham
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 your 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 (240) 276-0120 . 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/industry/support/index.html.
Sincerely yours,
Stupt Rhodes
Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number
Device Name: Cobalt™ HV Bone Cement
Indications for Use:
Cobalt™ HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.
Prescription Use X (Per 21 CFR 801.109)
..
OR
Over-The-Counter-Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hyst Rurda
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________