← Product Code [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD) · K014199 # SURGICAL SIMPLEX P WITH TOBRAMYCIN (K014199) _Howmedica Osteonics Corp. · LOD · May 6, 2003 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K014199 ## Device Facts - **Applicant:** Howmedica Osteonics Corp. - **Product Code:** [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD.md) - **Decision Date:** May 6, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3027 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Simplex™ P with Tobramycin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty. ## Device Story Simplex™ P with Tobramycin is an antibiotic-loaded acrylic bone cement; used for prosthesis fixation in second-stage revision total joint arthroplasty. Device consists of two sterile components: liquid monomer (methyl methacrylate, N,N-dimethyl-p-toluidine, hydroquinone) and powder copolymer (methylmethacrylate-styrene copolymer, polymethylmethacrylate, barium sulfate U.S.P., tobramycin sulfate U.S.P.). Components are mixed manually by clinician to initiate exothermic polymerization, creating a pliable, dough-like mass that hardens in situ. Tobramycin is released from the polymerized cement to provide local antibiotic coverage. Benefits include mechanical fixation of implants combined with local antibiotic delivery to the surgical site. ## Clinical Evidence Evidence includes literature review, contact with authors of relevant papers, and arthroplasty registry data. In vivo studies in rabbits evaluated antibiotic release from cement polymerized in situ; local concentrations in femoral bone bed and systemic levels were measured. Results show correlation between model predictions and clinical data from hemovac, serum, urine, and bone samples. Testing confirms safety and mechanical properties equivalent to predicate. ## Technological Characteristics Acrylic bone cement; two-component system (liquid monomer/powder copolymer). Materials: methyl methacrylate, N,N-dimethyl-p-toluidine, hydroquinone, methylmethacrylate-styrene copolymer, polymethylmethacrylate, barium sulfate U.S.P., tobramycin sulfate U.S.P. Principle: exothermic polymerization. Form factor: dough-like mass upon mixing. Sterilization: sterile components. ## 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 - Surgical Simplex® P Radiopaque Bone Cement (N-17-004) ## 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 for Simplex™ P with Tobramycin Simplex™ P with Tobramycin Bone Cement Proprietary Name: Common Name: Antibiotic Bone Cement 21 CFR 888.3027 Classification Name and Reference: Polymethylmethacrylate (PMMA) Bone Cement ।। Proposed Regulatory Class: MAY 0 6 2003 Device Product Code: OR (87) LOD For Information contact: Jennifer A. Daudelin Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 (201) 831-5379 Fax: (201) 831-6038 Email: Jdaudelin@howost.com April 28, 2003 Date Summary Prepared: #### Device Description Simplex™ P with Tobramycin is an acrylic bone cement intended for the fixation of prostheses to living bone for use in second stage revision for total joint arthroplasty. The cement is packaged in two sterile components; a liquid monomer component and a powder copolymer component. The liquid monomer component is comprised of methyl methacrylate, N.N-dimethyl-p-toluidine, and hydroquinone. The powder copolymer component consists of methylmethacrylate-styrene copolymer, polymethylmethacrylate, barium sulfate U.S.P., and tobramycin sulfate U.S.P. The liquid and powder components are mixed together resulting in the exothermic polymeric formation of a soft, pliable, dough-like mass. As the reaction progresses, a cement-like complex is formed. {1}------------------------------------------------ ## 510(k) Summary for Simplex™ P with Tobramycin ## Intended Use Simplex™ P with Tobramycin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty. ## Substantial Equivalence Simplex™ P with Tobramycin is substantially equivalent in intended use, overall materials, mechanical propertics, and operational principles to Surgical Simplex® P Radiopaque Bone Cement (Howmedica Osteonics N-17-004). #### Performance Data Information on the safe use of Simplex™ P with Tobramycin was initially gathered through traditional literature searching. Information in published papers was supplemented by contacting authors of the relevant papers for additional unpublished details. Finally, arthroplasty registries were contacted to determine whether they had data that might be relevant to the safe use of this product. The cumulative results of extensive in vitro and in vivo test data show that a balance is achieved between antibiotic release and mechanical integrity without threats of systemic toxicity or compromised mechanical function. Additional in vivo studies were performed, which evaluated the antibiotic release from cement polymerized in situ in rabbits. Local concentrations were measured in the femoral bone bed surrounding the cement, following animal sacrifice and excision, as well as systemic levels drawn throughout the study. The values predicted by the model correlate very well with clinical data from hemovac, serum, urine, and bone samples as reported by several clinicians. In summary, the testing demonstrates that, in terms of safety and mechanical properties, Simplex™ P with Tobramycin bone cement is substantially equivalent to the legally marketed predicate Surgical Simplex® P Bone Cement. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 0 6 2003 Ms. Jennifer A. Daudelin Regulatory Affairs Specialist Stryker Howmedica Osteonics 59 Route 17 South Allendale, NJ 07401 Re: K014199 Trade/Device Name: Simplex™ P with Tobramycin Regulation Number: 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: February 3, 2003 Received: February 4, 2003 Dear Ms. Daudelin: 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. Jennifer A. Daudelin 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 (301) 594-4659. 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/dsma/dsmamain.html Sincerely yours, Alan Witt 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 {4}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K014199 Simplex™ P with Tobramycin Device Name: Indications for Use: Simplex™ P with Tobramycin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty. Mark n millerer (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number _ (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) C Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K014199](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K014199) **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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