CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT

K021499 · DePuy Orthopaedics, Inc. · LOD · Jul 24, 2002 · Orthopedic

Device Facts

• Record ID: K021499
• Device Name: CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: Jul 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2

Intended Use

CEMVAC Ultra pre-packed with DePuy 1 Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

Device Story

In-syringe vacuum mixing system pre-packed with bone cement powder; includes syringe barrel, mixing rod, locking plate, filter/vacuum hose, vacuum pump adapter, monomer cartridge, and disposal bag. Used in orthopaedic surgery to prepare bone cement while controlling monomer fumes. Physician operates device to mix cement components; vacuum system reduces exposure to vapors. Output is prepared bone cement for prosthesis fixation. Benefits include improved safety via fume control and standardized mixing.

Clinical Evidence

Bench testing only. Testing compared compressive, flexural, and impact strengths of DePuy 1 Bone Cement mixed via CEMVAC Ultra versus traditional bowl and spatula methods. Results demonstrated comparable mechanical properties. No clinical data provided.

Technological Characteristics

Vacuum mixing system; pre-packed syringe barrel with bone cement powder and monomer cartridge. Components include mixing rod, locking plate, filter/vacuum hose, and vacuum pump adapter. Single-use. Materials identical to previously cleared DePuy 1 Bone Cement. Mechanical mixing principle.

Indications for Use

Indicated for fixation of prostheses to bone in orthopaedic musculoskeletal surgeries including rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction, and revision arthroplasty.

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

• Cemex System Gun Application Version (K000943)
• Howmedica Surgical Simplex P Radiopaque Bone Cement Pre-Packed in ACM and Mix Evac II (K002652)

Reference Devices

• DePuy 1 Bone Cement (P960001/Supplement 3)

Submission Summary (Full Text)

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## JUL 2 4 2002

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| 510(K) SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>P.O. Box 988<br>Warsaw, Indiana 46581-0988 |
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| MANUFACTURER: | DePuy International Ltd<br>Trading as DePuy CMW<br>Cornford Road<br>Blackpool, Lancashire<br>FY 4 4QQ, England |
| 510(K) CONTACT: | Janet Johnson, RAC<br>DePuy Orthopaedics, Inc.<br>Group Leader, Regulatory Submissions<br>[phone]; FAX [phone]<br>E-mail: [e-mail] |
| TRADE NAME: | CEMVAC Ultra Pre-packed with DePuy 1 Bone Cement |
| COMMON NAME: | Pre-packed Bone Cement Dispenser |
| CLASSIFICATION: | Cement Dispenser, Class I Exempt per 21 CFR 888.4200<br>PMMA Bone Cement: Class II per 21 CFR 888.3027 |
| DEVICE CODE: | KIH pre-packed with LOD |
| EQUIVALENT DEVICES: | DePuy 1 Bone Cement - P960001/Supplement 3<br>Cemex System Gun Application Version - K000943<br>Howmedica Surgical Simplex P Radiopaque Bone Cement Pre-<br>Packed in ACM and Mix Evac II - K002652 |

#### DEVICE DESCRIPTION AND INTENDED USE:

CEMVAC Ultra pre-packed with DePuy 1 Bone Cement is a in-syringe vacuum mixing system prepacked with bone cement powder. The subject device is for single use and helps control monomer fumes during the preparation of the cement. The subject device pre-packed with DePuy 1 Bone Cement is available in a single 60g or 100g unit and also in unit packs of 5. Each single unit (device) pack consists of 1) syringe barrel filled with bone cement powder; 2) central mixing rod; 3) locking plate; 4) filter/vacuum hose; 5) vacuum pump adapter; 6) monomer cartridge with glass ampoules containing bone cement liquid; and 7) plastic disposal bag.

CEMVAC Ultra pre-packed with DePuy 1 Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

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#### BASIS OF SUBSTANTIAL EQUIVALENCE:

With the exception of the primary packaging of the powder component of the DePuy 1 Bone Cement in the CEMVAC Ultra device, the DePuy 1 Bone Cement is identical in materials (formulation), and indications for use as the currently marketed DePuy 1 Bone Cement. On testing, DePuy 1 Bone Cement powder has been found to be compatible and stable in the CEMVAC Ultra device. Comparable DePuy 1 Bone Cement compressive, flexural and impact strengths were obtained for bowl and spatula and CEMVAC Ultra mixed cements.

CEMVAC Ultra pre-packed with DePuy 1 Bone Cement has similar indications for use as other bone cements currently marketed in the United States. These predicate devices include:

- 1) Cemex System Gun Application Version marketed by Tecres,
- 2) Howmedica Surgical Simplex P Radiopaque Cement Pre-Packed in ACM or Mix Evac II marketed by Stryker Corporation.

All three pre-filled mixing systems are pre-packed with bone cement and are intended to be used for the fixation of artificial joints prostheses to host bone.

Based on similarities of design, materials, intended use, and testing, DePuy believes that the CEMVAC Ultra pre-packed with DePuy 1 Bone Cement is substantially equivalent to the Cemex System Gun Application Version by Tecres, Howmedica Surgical Simplex P Radiopaque Cement Pre-Packed in ACM or Mix Evac II marketed by Stryker Corporation.

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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 4 2002

Ms. Janet G. Johnson, RAC DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 4681-0988

Re: K021499

Trade Name: CEMVAC Ultra Pre-packed with DePuy 1 Bone Cement Regulation Number: 21 CRF 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD Dated: May 8, 2002 Received: May 9, 2002

Dear Ms Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (OS) 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 – Ms. Janet G. Johnson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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 yours,

Mark N Millner

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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Indications for Use:

| 510(k) Number (if known): | " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " |
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Device Name: CEMVAC Ultra Pre-packed with DePuy 1 Bone Cement

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Indications for Use:

CEMVAC Ultra pre-packed with DePuy 1 Bone Cement is indicated for the fixation of prostheses to Uning bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

Concurrence of CDRH, Office of Device Evaluation

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Mark N. Millenn

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number.

Prescription Use X_OR

Over-The-Counter U

Over-The-Counter Use ___________ (Per 21 CFR 801.109)