← Product Code [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD) · K053198 # SIMPLEX P SPEEDSET BONE CEMENT (K053198) _Howmedica Osteonics Corp. · LOD · Jan 26, 2006 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K053198 ## Device Facts - **Applicant:** Howmedica Osteonics Corp. - **Product Code:** [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD.md) - **Decision Date:** Jan 26, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3027 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Simplex™ P SpeedSet bone cement is indicated for fixation of prostheses to living bone during orthopaedic musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, or revision of a previous arthroplasty. Simplex™ P SpeedSet bone cement is also indicated for the fixation of pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective. ## Device Story Simplex™ P SpeedSet Bone Cement is a radiopaque PMMA bone cement; supplied as sterile polymeric powder and liquid monomer ampoule for single-use. Applied digitally or via syringe by surgeons during orthopaedic procedures. Functions as a fixation agent for prostheses or pathological fractures. Working time ~4.8 minutes; dough time ~2.53 minutes; setting time ~8.2 minutes. Provides mechanical stabilization of implants to bone; benefits patients by restoring joint function and structural integrity in cases of severe bone loss or joint destruction. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on physical and handling characteristics (dough time, setting time, working time) compared to predicate devices. ## Technological Characteristics Radiopaque PMMA bone cement. Components: sterile polymeric powder and liquid monomer. Application: digital or syringe. Setting properties: 4.8 min working time, 2.53 min dough time, 8.2 min setting time. Class II device. ## 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 - Simplex P bone cement (PMA N17004) - Palacos R bone cement ([K030902](/device/K030902.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}------------------------------------------------ JAN 2 6 2006 Image /page/0/Picture/1 description: The image contains the word "Stryker" in a bold, sans-serif font, followed by the letter "K" and the number "053198" in a handwritten style. Below "Stryker", the word "Howmedica" is written in a bold, sans-serif font. Underneath "Howmedica", the word "OSTEONICS" is written in a regular, sans-serif font. 510(k) Summary of Safety and Effectiveness Simplex™ P SpeedSet Bone Cement 325 Corporate Drive Mahwah, NJ USA 07430 | Proprietary Name: | Simplex TM P SpeedSet Bone Cement | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | PMMA Bone Cement | | Classification Name and Reference | Polymethylmethacrylate (PMMA) bone cement
21 CFR §888.3027 | | Regulatory Class: | Class II | | Device Product Code: | 87 LOD - Polymethylmethacrylate (PMMA) bone cement. | | Device Manufacturer: | Howmedica International S. de R.L.
Raheen Business Park, Limerick, Ireland | | For Information contact: | Tiffani Rogers
Regulatory Affairs Specialist
Stryker Orthopaedics
325 Corporate Drive
Mahwah, New Jersey 07432
Phone: (201) 831-5412
Fax: (201) 831-6038
E-Mail: Tiffani.Rogers@stryker.com | | Date Summary Prepared: | November 14, 2005 | ## Device Description Simplex™ P SpeedSet Bone Cement is a radiopaque bone cement capable of being applied digitally and with a syringe. The cement will be available in 10-pack of 10-pack of 1-pack dispensers, with each individual pack containing one 40.0g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use. The working time of the Simplex™ P SpeedSet Bone Cement is approximately 4.8 minutes, with a dough time of 2.53 minutes and a setting time of 8.2 minutes. {1}------------------------------------------------ ## Indications For Usc: Simplex™ P SpeedSet bone cement is indicated for fixation of prostheses to living osteoorthritis treasedie musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to transmal or other conditions, or revision of a previous arthroplastical posted bone coment is also indivors, or revision of a fixation of pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective. ## Substantial Equivalence: The Simplex™ P SpeedSet bone cement has the same indications, same liquid monomer and similar powder component as Simplex™ P bone cement. Additionally, the Simplex™ P SpeedSet bone cement is similar in dough time, setting time, setting time and working time as Palacos R bone cement. Howmedica Osteonics Corp. believes the SimplexTM P SpeedSet bone cement to be substantially equivalent to Simple® I bone cement approved in PMA N17004 and Palacos R bone cement to Smpless P bone cement approved in PMA N17004 and Palacos R bone cement cleared in K030902. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three stylized lines representing its wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The seal is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 6 2006 Ms. Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430 Re: K053198/S1 Trade/Device Name: Simplex PTM SpeedSet Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: PMMA Bone Cement Regulatory Class: II Product Code: LOD Dated: January 18, 2006 Received: January 19, 2006 Dear Ms. Rogers: 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 - Tiffani Rogers 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 (240) 276-0120 . 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, 25 Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): _K1253199 Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications Simplex™ P SpeedSet bone cement is indicated for fixation of prostheses to living bone during orthopaedic musculoskeletal procedures for rheumatoid ecthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen discase, severe joint destruction secondary to trauma or other conditions, or revision of a previous arthroplasty. Simplex™ P SpeedSet bone cement is also indicated for the fixation of pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective. Prescription Use X (Per 21 CFR 801.109) OR Over-the-Counter Use (Please Do Not Write Below This Line – Continue on Another Page if Needed) 2 (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number_KoS31 99 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K053198](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K053198) **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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