← Product Code [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD) · K081155 # SMARTSET MV BONE CEMENT (K081155) _DePuy Orthopaedics, Inc. · LOD · May 14, 2008 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K081155 ## Device Facts - **Applicant:** DePuy Orthopaedics, Inc. - **Product Code:** [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD.md) - **Decision Date:** May 14, 2008 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3027 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use SmartSet MV 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 MV Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) based bone cement. It is used by surgeons during arthroplasty procedures to secure metal or polymeric prostheses to living bone. The cement acts as a fixation medium to stabilize the implant within the musculoskeletal system. It is intended for clinical use in orthopaedic surgical settings. ## Clinical Evidence No clinical data provided; substantial equivalence is based on technological and formulation characteristics equivalent to predicate devices. ## Technological Characteristics Self-curing, radiopaque, polymethylmethacrylate (PMMA) based bone cement. Class II device (21 CFR 888.3027, Product Code LOD). ## Regulatory 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 MV Endurance Bone Cement ([P960001](/device/P960001.md)) - SmartSet HV Bone Cement ([K023012](/device/K023012.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 510(k) Summary K081155 MAY 14 2008 | Date Prepared: | 21 April 2008 | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Sponsor: | DePuy Orthopaedics, Inc
700 Orthopaedic Drive
Warsaw, Indiana 46581 - 0988 | | Establishment Registration
No: | 1818910 | | Contact Person: | Suzana Otaño
Project Manager, Regulatory Affairs
Telephone: 305-269-6386
Fax: 305-269-6441
Email: sotano@dpyus.jnj.com | | Trade Name of Device: | SmartSet MV Bone Cement | | Common Name: | Bone cement | | Classification Name: | Bone cement (21 CFR 888.3027, Product Code LOD) | | Equivalent to: | SmartSet MV Endurance Bone Cement (P960001, previously
branded Endurance Bone Cement)
SmartSet HV Bone Cement (K023012) | | Device Description: | SmartSet MV Bone Cement is a self-curing, radiopaque,
polymethylmethacrylate based cement. The bone cement is
used for securing a metal or polymeric prosthesis to living
bone in arthroplasty procedures. | | Intended Use: | SmartSet MV 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. | | Technological
Characteristics: | The technological characteristics of the SmartSet MV Bone
Cement are equivalent to the predicate devices. | : : Page 25 of 108 : : {1}------------------------------------------------ Substantial Equivalence: The indications, intended use, formulation and finished product specifications of the SmartSet MV Bone Cement are equivalent to the predicate devices. . . · . : · : : . : . : . : and the comments of the comments of : : . . í . Special 510(k) SmartSet MV Bone Cement April 2008 : {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is composed of thick, black lines. Surrounding the eagle is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA". MAY 1 4 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DePuy Orthopaedics, Inc. % Ms. Suzana Otano Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, IN 46581-0988 Re: K081155 Trade/Device Name: SmartSet MV Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: April 21, 2008 Received: April 23, 2008 Dear Ms. Otano: 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. {3}------------------------------------------------ Page 2 - Ms. Suzana Otano 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Mark M. Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use Statement 510(k) Number: Device Name: SmartSet MV Bone Cement Indications For Use: SmartSet MV 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. × Prescription Use (Per 21 CFR 801 Subpart D) 1. 1. AND/OR Over-the-Counter (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mitke Dola for mkm Page 1 of 1 (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K081155 Special 510(k) SmartSet MV Bone Cernent April 2008 Page 24 of 108 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K081155](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K081155) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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