Cobalt™ G HV 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.

Device Description

Cobalt GTM HV Bone Cement is a fast setting polymethylmethacrylate) cement for use in bone surgery. Mixing of the two sterile components, consisting of a powder and a liquid, initially produces a paste that is used to anchor a joint prosthesis or to fill an osseous defect. The hardened bone cement allows stable fixation of the prosthesis and transfers stresses produced on movement to the bone via the large interface. Insoluble zirconium (IV) oxide is included in the cement powder as an x-ray contrast medium. The FD&C Blue No. 2 Aluminum Lake color additive serves as optical marking of the bone cement at the site of the operation. The gentamicin component is a broad-spectrum antibiotic.

AI/ML Overview

This document describes the Cobalt G™ HV Bone Cement, a polymethylmethacrylate (PMMA) bone cement, and its substantial equivalence to predicate devices. It focuses on the non-clinical testing performed to demonstrate this equivalence.

Since no clinical efficacy or diagnostic performance study was conducted, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance) are not applicable. The device relies on non-clinical comparative testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list specific numerical acceptance criteria for each test. Instead, it states that the results of the comparative testing showed that Cobalt G™ HV Bone Cement possesses "chemical, physical, mechanical and handling characteristics necessary to fulfill its intended use" and that it is "equivalent to Palacos® G (with gentamicin) for its primary intended use." The general acceptance criterion was substantial equivalence to the predicate device, Palacos® G Bone Cement.

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance (Cobalt G™ HV Bone Cement)
Chemical	To be substantially equivalent to Palacos® G (with gentamicin).	Demonstrated substantial equivalence in chemical composition (primary difference being the color additive FD&C Blue No. 2 Aluminum Lake, which is FDA approved).
Physical	To be substantially equivalent to Palacos® G (with gentamicin).	Demonstrated substantial equivalence in physical characteristics.
Mechanical	To be substantially equivalent to Palacos® G (with gentamicin).	Demonstrated substantial equivalence in mechanical characteristics.
Handling	To be substantially equivalent to Palacos® G (with gentamicin).	Demonstrated substantial equivalence in handling characteristics.
Sterilization	Processed and sterilized in an equivalent manner to predicate device.	Processed and sterilized in an equivalent manner to Palacos® G.
Packaging	Equivalent to legally marketed devices (Generation 4® Bone Cement, K993836).	Equivalent to Generation 4® Bone Cement.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The testing was in vitro comparative testing, meaning it was conducted in a laboratory setting using material samples, not a patient-based test set.
Data Provenance: In vitro laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for in vitro physical, chemical, and mechanical tests is established by standardized testing methods and measurements, not expert consensus in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC study was not performed. This device is a bone cement, and its performance is assessed through material properties, not diagnostic accuracy requiring human reader interpretation.

6. Standalone Performance Study

No, a standalone (algorithm only without human-in-the-loop performance) study was not performed. The "performance" of this device is its material characteristics, which were compared to a predicate, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the in vitro comparative testing consisted of established standards for material properties, chemical composition analysis, and physical/mechanical testing protocols. The direct comparison was made against the characteristics of the legally marketed predicate device, Palacos® G Bone Cement.

8. Sample Size for the Training Set

Not applicable. This device is a medical device (bone cement) and does not involve AI or machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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K051532

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AUG 3 - 2005

510(k) Summary

Cobalt G™ 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 GTM HV Bone Cement

Common Name: PMMA Bone Cement

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Predicate Device: Palacos® G Bone Cement Cleared by: Biomet 510(k) Notification (K030086) 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:

The powder component is supplied in a polyethylene-coated paper packet. It consists of 40 grams of powder (copolymer) with the following composition:

• Methylmethacrylate-methylacrylate copolymerwith FD&C Blue No. 2 Aluminum Lake	33.42 - 33.86 grams
• Benzoyl peroxide, hydrous 75%	0.20 - 0.64 grams
• Zirconium dioxide	5.94 grams
• Gentamicin sulfate (equivalent to 0.5 grams gentamicin)	0.835 grams

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K051532

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The liquid component is supplied in a flexible packet. It consists of 20 ml of liquid (monomer) with the following composition:

Methylmethacrylate (stabilized with hydroquinone) 18.424 grams . 0.376 grams
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.

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 hard within 15 minutes.

Intended Use / Indications for Use:

Cobalt GTM HV Bone Cement with gentamicin 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 the Technological Characteristics:

The components of Cobalt GTM HV Bone Cement are substantially equivalent to the legally marketed device Palacos® G Bone Cement. Both cements are processed and sterilized in an equivalent manner, the primary difference being the addition of color additive FD&C Blue No. 2 Aluminum Lake. The FDA has approved the new color additive (FD&C Blue No. 2 Aluminum Lake) for use in bone cement.

Non-Clinical /Clinical Testing:

The substantial equivalence to Palacos® G was determined by in vitro comparative testing to Cobalt GTM HV Bone Cement and comparatively analyzing the relevant data. The results showed that Cobalt GTM HV Bone Cement possesses chemical, physical, mechanical and handling characteristics necessary to fulfill its intended use. In summary, Cobalt GTM HV Bone Cement (with gentamicin) is equivalent to Palacos® G (with gentamicin) for its primary intended use of fixation of prosthetic components as described in the device labeling. No clinical testing was performed.

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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 entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 - 2005

Mr. Lonnie Witham Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K051532

Trade/Device Name: Cobalt™ G HV Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: July 13, 2005 Received: July 14, 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.

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. 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 Rlurdu

Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number

Device Name: Cobalt™ G HV Bone Cement

Indications for Use:

Prescription Use X (Per 21 CFR 801.109)

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)

Stupd Rurds

Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.”