(331 days)
No
The 510(k) summary describes a bone cement and does not mention any software, algorithms, or AI/ML capabilities. The focus is on the material properties and intended use as a physical substance.
Yes
The device is indicated for the fixation of pathological fractures, which is a therapeutic intervention aimed at treating a medical condition.
No
PMA indicates the device is a bone cement for fixation of pathological fractures, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "bone cement" with "two separate, pre-measured sterilized components which when mixed form a radiopaque, rapidly setting bone cement." This describes 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.
- Device Function: The Cobalt™ V Radiopaque Vertebroplasty Bone Cement is a material that is implanted into the body to fix fractures. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for "fixation of pathological fractures," which is a treatment procedure.
- Device Description: The description focuses on its physical properties as a bone cement.
The information provided about the device's function and intended use clearly places it outside the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Cobalt™ V Radiopaque Vertebroplasty Bone Cement is indicated for the fixation of pathological fractures of the vertebral body due to osteoporosis, benign lesions and malignant lesions using a vertebroplasty or kyphoplasty procedure.
Product codes
LOD, NDN
Device Description
Cobalt™ V Radiopaque Vertebroplasty Bone Cement provides two separate, pre-measured sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body
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: 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)
Osteopal® V - Heraeus Kulzer GMBH (K050085), Spineplex™ Radiopaque Bone Cement -- Stryker (K032945), Cobalt" HV Bone Cement - Biomet Inc. (K051496)
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/0 description: The image shows the word "BIOMET" in a stylized, blocky font. Each letter is outlined in black, giving it a bold and distinct appearance. The letters are connected, forming a single, unified wordmark.
510(k) Summary
| Preparation Date: | December 22, 2006 | NOV 3 0 2007 |
|---|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corporation | |
| Contact Person: | Gary E. Baker | |
| Proprietary Name: | CobaltTM V Radiopaque Vertebroplasty Bone Cement | |
| Common Name: | PMMA Bone Cement | |
| Classification Name: | Polymethylmethacrylate (PMMA) Bone Cement (§ 888.3027) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Osteopal® V - Heraeus Kulzer GMBH (K050085) Spineplex™ Radiopaque Bone Cement -- Stryker (K032945) Cobalt" HV Bone Cement - Biomet Inc. (K051496)
Device Description: Cobalt™ V Radiopaque Vertebroplasty Bone Cement provides two separate, pre-measured sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
Intended Use: Cobalt™ V Radiopaque Vertebroplasty Bone Cement is indicated for the fixation of pathological fractures of the vertebral body due to osteoporosis, benign lesions and malignant lesions using a vertebroplasty or kyphoplasty procedure.
Summary of Technologies: Cobalt™ V Radiopaque Vertebroplasty Bone Cement has the same indications for use and technology as the predicate devices. Cobalt" V Radiopaque Vertebroplasty Bone Cement is made of the same components as the predicate Cobalt™ HV Bone Cement. The ratio of ingredients has been modified to meet specific customer needs for vertebroplasty and kyphoplasty applications.
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. except for Osteopal® V and Spineplex
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MAHING ADDRESS SHIPPING ADDRESS P.O. Box 587 Warsaw, IN 46581 0587 ()ドFFICE PAX 그
574.267-66.41)
574.267.8137
56 E. Rell Drive Warsaw, IN 46582
.
E-MAII biomet@biomet.com
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2007
Biomet Manufacturing Corporation %Gary E. Baker Regulatory Specialist PO Box 587 Warsaw, Indiana 46581
Re: K070015
Trade/Device Name: Cobalt V Radiopaque Vertebroplasty Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD, NDN Dated: October 30, 2007 Received: November 02, 2007
Dear Mr. Baker:
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 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 - Mr. Gary E. Baker
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mcllheran
- Mark N. Melkerson Director Division of General, Restorative and Neurological 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™ V Radiopaque Vertebroplasty Bone Cement
Indications For Use:
Cobalt™ V Radiopaque Vertebroplasty Bone Cement is indicated for the fixation of pathological fractures of the vertebral body due to osteoporosis, benign lesions and malignant lesions using a vertebroplasty or kyphoplasty procedure.
Prescription Use X (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
(Division S 10-3-011 Division of General, Restoration and Neurological Devices
510(k) Number: 10700015