SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT

K053445 · DePuy Orthopaedics, Inc. · LOD · Jan 6, 2006 · Orthopedic

Device Facts

• Record ID: K053445
• Device Name: SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: Jan 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SmartSet HV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty. SmartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Story

SmartMix Cemvac is a vacuum mixing and syringe delivery system pre-packed with PMMA bone cement powder and liquid. System facilitates mixing and delivery of bone cement during orthopaedic procedures. Device used in clinical settings by surgeons/staff to fixate prostheses to living bone. Vacuum mixing reduces porosity; improves cement handling; enhances delivery. System provides closed-loop preparation to minimize exposure to cement fumes. Output is dispensed cement for joint arthroplasty or revision procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

PMMA bone cement; vacuum mixing and syringe delivery system. Materials and chemical composition identical to predicate SmartSet HV and SmartSet GHV Gentamicin cements. System provides vacuum-assisted mixing to reduce porosity.

Indications for Use

Indicated for patients undergoing orthopaedic musculoskeletal surgery requiring prosthesis fixation (rheumatoid/osteoarthritis, trauma, osteoporosis, avascular necrosis, collagen disease, revision arthroplasty). GHV Gentamicin variant indicated for second-stage revision of total joint arthroplasty following infection clearance.

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

• SmartSet HV Bone Cement (K023012)
• SmartSet GHV Gentamicin Bone Cement (K033563)

Reference Devices

• SmartMix Pre-filled Mixing System (K042591)
• Cemvac Ultra Pre-packed with DePuy Bone Cement (K021499)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF SPONSOR: | DePuy Orthopaedics. Inc.<br>700 Orthopaedic Drive<br>P.O. Box 988<br>Warsaw, Indiana 46581-0988 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER: | DePuy International Ltd<br>Trading As DePuy CMW<br>Cornford Road<br>Blackpool, Lancashire<br>FY4 4QQ, England |
| 510(k) CONTACT: | Natalie S. Heck<br>DePuy Orthopaedics, Inc.<br>Manager, Regulatory Affairs<br>Tel.: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| TRADE NAME: | SmartMix Cemvac Pre-filled with SmartSet HV Bone Cement<br>SmartMix Cemvac Pre-filled with SmartSet GHV Gentamicin<br>Bone Cement |
| COMMON NAME: | PMMA Bone Cement |
| CLASSIFICATION: | PMMA Bone Cement:<br>Class II per 21 CFR 888.3027 |
| | Cement Mixer for Clinical Use:<br>Class I Exempt per CFR 888.4210 |
| | Cement Dispenser:<br>Class I Exempt per 21 CFR 888.4200 |
| DEVICE CODES: | LOD, MBB, KIH, JDZ |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | SmartSet HV Bone Cement:<br>K023012<br>SmartSet GHV Gentamicin Bone Cement:<br>K033563 |

SmartMix Pre-filled Mixing System K042591

Cemvac Ultra Pre-packed with DePuy | Bone Cement K021499

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### DEVICE DESCRIPTIONS AND INDICATIONS:

SmartMix Cemvac is a vacuum mixing and syringe delivery system pre-packed with bone cement powder and liquid. The device is available in a single 60g or 80g unit. This submission adds SmartMix Cemvac pre-filled with SmartSet HV Bone Cement and SmartMix Cemvac pre-filled with SmartSet GHV Gentamicin Bone Cement to the SmartMix Cemvac line.

SmartSet HV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

SmartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

### BASIS FOR SUBSTANTIAL EQUIVLENCE:

Based on the similarities of design, materials, intended use and testing results, SmartMix Cemvac pre-filled with SmartSet HV Bone Cement and SmartMix Cemvac pre-filled with SmartSet GHV Gentamicin Bone Cement are substantially equivalent to the same bone cements, packaged in traditional bone cement packaging.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wave-like lines emanating from it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 2006 JAN 6

Ms. Natalie S. Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K053445

Trade/Device Name: SmartMix Cemvac Pre-filled with SmartSet HV Bone Cement SmartMix Cemvac Pre-filled with SmartSet GHV Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: PMMA Bone Cement Regulatory Class: II Product Code: LOD, MBB, KIH, JDZ Dated: December 8, 2005

Received: December 12, 2005

Dear Ms. Heck:

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

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Page 2 - Ms. Heck

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.

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 [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 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/industry/support/index.html.

Sincerely yours,

Mark N. 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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

### Device Name:

SmartMix Cemvac Pre-filled with SmartSet HV Bone Cement

### Indications for Use:

SmartSet HV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

### Device Name:

SmartMix Cemvac Pre-filled with SmartSet GHV Gentamicin Bone Cement

#### Indications for Use:

SmartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Prescription Use: X Part 21 CFR 801 Subpart D AND/OR

Over-The-Counter Use: _ 21 CFR 807 Subpart C

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RANO fice of Device Evaluation (ODE) nial 977 of Station (Division Sign-( Division of General, Restorative, and Neurological Devices

510(k) Number K053445