SMARTSET HV BONE CEMENT

K023012 · DePuy Orthopaedics, Inc. · LOD · Feb 13, 2003 · Orthopedic

Device Facts

• Record ID: K023012
• Device Name: SMARTSET HV BONE CEMENT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: Feb 13, 2003
• 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.

Device Story

SmartSet HV Bone Cement is a high-viscosity PMMA bone cement; supplied as a two-component system (polymeric powder and monomeric liquid). Used in orthopaedic musculoskeletal surgical procedures for prosthesis fixation. Applied by surgeon via digital or syringe methods. Features short dough time (~1 min) and 9-11 minute setting time; allows for long working time suitable for modern cementing techniques. Single-use device. Provides mechanical fixation of artificial joints to host bone; facilitates stability in joint replacement or revision surgeries.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, materials, and bench testing.

Technological Characteristics

High-viscosity PMMA bone cement. Two-component system: polymeric powder and monomeric liquid. Single-use. Suitable for digital or syringe application.

Indications for Use

Indicated for fixation of prostheses to living bone in orthopaedic musculoskeletal surgery for patients with rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma, or revision of previous 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

• DePuy 1 Bone Cement (P960001/Supplement 3)
• Palacos R40 Bone Cement (P810020/Supplement 3)

Submission Summary (Full Text)

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# FEB 1 3 2003

K023012

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| SPONSOR OF THIS 510(K): | 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: | SmartSet HV Bone Cement |
| COMMON NAME: | PMMA Bone Cement |
| CLASSIFICATION: | PMMA Bone Cement: Class II per 21 CFR 888.302 |
| DEVICE CODE: | LOD |
| EQUIVALENT DEVICES: | DePuy 1 Bone Cement - P960001/Supplement 3<br>Palacos R40 Bone Cement - P810020/Supplement 3 |

#### DEVICE DESCRIPTION AND INTENDED USE:

SmartSet HV Bone Cement is a high viscosity bone cement which is equally suited for both digital and syringe use. It has a short dough time (approximately 1 minute), a setting time of 9 -11 mins and consequently a long working time. These handling characteristics make SmartSet HV Bone Cement ideally suited for use with modern cementing techniques and clinical applications. The subject device is for single use only and is available in either 20g or 40g single unit packs and 10 ×1 unit dispenser cartons. Each single unit (device) pack consists of a polymeric powder component and a monomeric liquid component.

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.

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K 023012

### BASIS OF SUBSTANTIAL EQUIVALENCE:

SmartSet HV Bone Cement has similar indications for use as other bone cements currently marketed in the United States. These predicate devices include:

- 1) DePuy 1 Bone Cement
- 2) Palacos R40 Bone Cement

All three bone cements are intended to be used for the fixation of artificial joints and prosthesis to host bone.

Based on similarities of design, materials, intended use, and testing performed, DePuy believes that the subject SmartSet HV Bone Cement is substantially equivalent to the above described FDA cleared devices currently on the market.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFB 1 3 2003

Ms. Janet G. Johnson, RAC DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K023012

Trade Name: SmartSet HV Bone Cement Regulation Number: 21 CRF 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD Dated: January 3, 2003 Received: January 6, 2003

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 (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 -- 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]. 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 Mulkeren

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)

Device Name: SmartSet HV Bone Cement

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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, osteoarthitis, 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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for Mark n Mckeen
Division Sign-

Divisio: and Neurological Dev

KO 23012 710(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use