← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K984623 # MAXIM REMOVABLE MOLDED POLY TIBIA (K984623) _Biomet, Inc. · JWH · Mar 5, 1999 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K984623 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Mar 5, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Indications for use of knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant intended for use with bone cement. ## Device Story Maxim Removable Molded Poly Tibia is a knee joint replacement prosthesis component; replaces tibial articulating surface in total joint replacement. Device consists of CoCr tibial plate with removable molded UHMWPE tibial bearing; designed for use with previously cleared Maxim femoral components (K915132). Implanted by orthopedic surgeons in clinical/hospital settings; requires fixation with acrylic bone cement. Provides stable articulating surface to restore joint function; alleviates pain/disability associated with arthritis or previous surgical failure. Single-use implant. ## Clinical Evidence No clinical data provided; substantial equivalence based on design and functional comparison to existing marketed devices. ## Technological Characteristics CoCr tibial plate; removable molded UHMWPE tibial bearing. Intended for cemented fixation only. Minimum polyethylene thickness under condyles is 6.6 mm for the 12mm insert. Single-use implant. ## Regulatory Identification A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Reference Devices - Maxim femoral components ([K915132](/device/K915132.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}------------------------------------------------ K98 4623 SUMMARY OF SAFETY AND EFFECTIVENESS Sponsor: Biomet, Inc. Airport Industrial Park Warsaw, Indiana 46580 Maxim Removable Molded Poly Tibia Device: Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Intended Use: Indications for use of knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant. Device Description: The Maxim Removable Molded Poly Tibia is intended to replace the tibial articulating surface in a total joint replacement with Maxim femoral components cleared in 510(k) K915132. This device is a CoCr tibial plate with a removable molded UHMWPE tibial bearing that can be used with previously cleared modular Maxim tibial bearings. Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to: Reaction to bone cement Fracture of the components Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Delayed wound healing Fracture of the cement - Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Metal sensitivity Dislocation Substantial Equivalence: In function and overall design the Maxim Removable Molded Poly Tibia Prosthesis is equivalent to other commercially available tibial components currently on the market. {1}------------------------------------------------ Image /page/1/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 top half of the circle. In the center of the seal is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 5 1999 Mr. Fred McClure Regulatory Specialist Biomet®, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K984623 Maxim Removable Molded Poly Tibia Requlatory Class: II Product Code: JWH Dated: February 16, 1999 Received: February 17, 1999 Dear Mr. McClure: We have reviewed your Section 510(k) 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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations: - The thinnest tibial insert available is the nominal 1. "12mm" sized insert, which has a minimum polyethylene thickness under the condyles of 6.6 mm. - 2. This device may not be labeled or promoted for noncemented use. - 3. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only. {2}------------------------------------------------ Page 2 - Mr. Fred McClure - Any non-cemented fixation of this device is considered 4 . investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be {3}------------------------------------------------ Page 3 - Mr. Fred McClure obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Turell C. Payne Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page _1_ of _1_ 510 (k) Number (if known) : £ 984623 Maxim Removable Molded Poly Tibia Device Name: Indications for use of knee joint replacement prostheses include: 1) painful and Indications For Use: disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction of unsuccessful osteotomy or arthrodesis. The device is a single use implant intended for use with bone cement. 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