PALACOS R BONE CEMENT WITH GENTAMICIN

K030086 · Biomet, Inc. · LOD · Dec 17, 2003 · Orthopedic

Device Facts

• Record ID: K030086
• Device Name: PALACOS R BONE CEMENT WITH GENTAMICIN
• Applicant: Biomet, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: Dec 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Palacos® G 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.

Device Story

Palacos® G is a two-component, fast-setting polymethylmethacrylate (PMMA) bone cement containing gentamicin sulfate. Components consist of a powder (PMMA copolymers, zirconium oxide, benzoyl peroxide, chlorophyll, gentamicin) and a liquid (methyl methacrylate monomer, N,N-dimethyl-p-toluidine, chlorophyll). Mixing initiates polymerization; accelerator (N,N-dimethyl-p-toluidine) speeds free radical generation; stabilizer prevents premature polymerization. Resulting paste anchors metal/plastic prostheses to bone, transferring mechanical stresses across the interface. Used in OR by surgeons during joint arthroplasty. Gentamicin provides broad-spectrum antibiotic properties to aid in revision settings. Hardens within 15 minutes. Benefits include stable prosthetic fixation and localized antibiotic delivery in revision arthroplasty.

Clinical Evidence

No clinical data. Substantial equivalence supported by comparative bench testing against Palacos® R and established clinical history of gentamicin-impregnated bone cement in Europe.

Technological Characteristics

Two-component PMMA bone cement. Powder: Methyl acrylate-methyl methacrylate copolymers, Zirconium (IV) oxide (radiopaque), Benzoyl peroxide (initiator), Chlorophyll (colorant), Gentamicin sulfate. Liquid: Methyl methacrylate monomer, N,N-Dimethyl-p-toluidine (accelerator), Chlorophyll. Polymerization via free radical mechanism. Manual mixing. Sterile components.

Indications for Use

Indicated for patients undergoing hip, knee, or other joint arthroplasty requiring fixation of prosthetic components to living bone, specifically for two-stage revision procedures following joint infection.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Palacos® R (P810020)

Submission Summary (Full Text)

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K030086 page 17

# DEC 17 2003

## 510(k) Summary of Safety and Effectiveness Palacos® G Bone Cement with Gentamicin

Submitter's Name and Address: Biomet Inc., P.O. Box 587 S6 East Bell Drive Warsaw, IN 46581

Contact Person: Lonnie Witham Biomet Inc. P.O. Box 587 Warsaw, IN 46581

Name of the Device: Palacos® G Bone Cement (with Gentamicin)

Legally marketed device to which the submitter claims substantial equivalence: Legally marketod de needs to m. FDA PMA No. P810020 (1984) - Subsequently reclassified into class II.

### Description Of Palacos® G (with Gentamicin)

Description O1 1 anacos® O (With Gentamicin)
Palacos® G (with gentamicin) is a fast setting polymer (polymethylmethacy from don Fillacosw O (with gentamism) is a the two sterile components, consisting of a powder and a liquid, initially produces a paste, which is used to anchor the prosthesis or to fill an and a inquiry intrially produced bone cement allows stable fixation of the prosthesis and transfers stresses produced on movement to the bone via the large interface. Insoluble translers succioi in included in the cement powder as an x-ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the omorophyn Batalavamicin component is a broad-spectrum antibiotic.

#### Material used:

#### 40.8 grams powder

| Gentamicin sulfate (equivalent to 0.5 grams Gentamicin) | 0.835 grams |
|---------------------------------------------------------|-----------------------|
| Methyl acrylate-methyl methacrylate copolymer (6:94) | 27.77 grams |
| Methyl acrylate-methyl methacrylate copolymer (42:58) | 5.68 grams |
| Zirconium (IV) oxide (mono-clinic) | 6.13 grams |
| Benzoyl peroxide | 0.315 grams |
| Chlorophyll | 0.008 grams (200 ppm) |

Methylmethacrylate copolymer is the primary constituent of the powder component. Mediaci yiate coporymer is alle pacifier. Chlorophyll is added as a colorant to distinguish polymer from bone at the site of operation. Benzoylperoxide is a starter. All ulstinginsit poryiner from arment. Gentamicin® sulfate is an antibiotic that has been used in bone cement in Europe for approximately 20 years.

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K030086 page 72

20 ml liguid Methyl methacrylate N, N-Dimethyl-p-toluidine Chlorophyll

18.4 grams 0.38 grams 0.005 grams (200 ppm)

Methymethacrylate monomer is the primary constituent of the liquid component. In much Methyliedlaci yiate monomer 16 the primary over the stablidine, and the stabilizer, smaller qualifics are the accelerative in the stituents of PMMA bone cement.

## Scientific concepts, significant physical and performance characteristics:

Scientific concepts, significant puyscal and pixed, the accelerator speeds the generation When the powder and liquid components and many of the early free radicals,
of free radicals and the stabilizer in the liquid reacts with many of the early free radicals, of tree radicals and the Stabilized in the rigard reason formation of polymer chains.
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 Polymerizanon proceeds stowly over the fire rowly formed polymer chans, while
of the powder beads mingle with monomer and newly researce rises as set time of of the powder beads millgre with modiomer and now for rises as set time of the smaller beads may dissolve completely. The concern valiped and the bone cement hard within 15 minutes.

Palacos® G with gentamicin is made of the same materials as the approved bone cements Palacos® G with gemaintient is made of the same to be compatible and have a long
Palacos® R (P 810020). These materials have shown to be compatible and have a for Palacos® K (F 810020). These materials no retamicin has been used in Europe for approximately 20 years. Since Palacos® G (with gentamicin) is the same cement as approximately 20 years. Shice Falacose & (vines girstituents added nor removed),
Palacos® R approved in P810020 (1984) (no chemical vecco in Europe, no Palacos® R approved in P810020 (1964) (1964) (1984) (1984) 1984 119 11999) 1999 1999, 10 toxicological studies have been conducted.

### Statement of intended use of the device:

Palacos® G with gentamicin is indicated for use as bone cement in arthroplasty Palacosw of the hip, knee and other joints to fix plastic and metal prosthetic parts to procedures of the hip, Kice and outler joints to inx previous of previous arthroplasty living bone when reconstruction. The coment is intended for the new prositesis
procedures due to joint infection. The coment is intense has been cleared procedures and to John firection. The center is the initial infection has been cleared

## Summary of the technological characteristics of the new device in comparison to those of the predicate device:

those of the predicate device.
The components of Palacos® G (with gentamicin) are identical to the difference is the I he components of Falacos® O (with genearsed and sterilized. The only difference is the device Palacos® K and are identically proveder component. Palacos® R impregnated with gentamicin has a long clinical history of use in Europe.

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K030086 page 373

The effectiveness and substantial equivalence of Palacos® G (with gentamicin) was The Creenveness and substantial equivparative testing to Palacos® R and by comparing the relevant data. The results showed that Palacos® G (with gentamicin) possesses mechanical and chemical characteristics to fulfill its intended use.

In summary, Palacos® G with gentamicin is safe and effective for use in the abovementioned indications. Palacos® G is substantially equivalent to Palacos® R for its primary intended use of fixation of prosthetic components.

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Image /page/3/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 three bars representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2003

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

Re: K030086

Trade/Device Name: Palacos® G Bone Cement with Gentamicin Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD and MBB Dated: September 19, 2003 Received: September 22, 2003

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 complics 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. Lonnic 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), plcase contact the Office of Compliance at [phone]. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Mark A. Melkersen

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

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### STATEMENT OF INDICATIONS FOR USE

510(k) Number

Device Name: Palacos® G Bone Cement with Gentamicin

#### Indications for Use:

Palacos® G 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.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use No
(Optional Format 1-2-96)

Mark A. Mellers

morel, Restorative