← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K063732 # MICROPLASTY TIBIAL TRAYS (K063732) _Biomet Manufacturing Corp · JWH · Jan 18, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K063732 ## Device Facts - **Applicant:** Biomet Manufacturing Corp - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Jan 18, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Non-coated (Interlok®) devices are indicated for cemented application only. ## Device Story Biomet® Microplasty Tibial Tray is a knee prosthesis component; designed for use in minimally invasive knee procedures. Features shorter stem compared to traditional trays to facilitate insertion through smaller incisions. Constructed from Co-Cr-Mo alloy. Used by orthopedic surgeons in clinical settings during total knee arthroplasty. Device serves as a base for tibial knee bearings; provides structural support for the joint replacement. Benefits patient by enabling minimally invasive surgical approach, potentially reducing tissue trauma and recovery time. ## Clinical Evidence No clinical data. Substantial equivalence supported by non-clinical bench testing confirming adherence to Class II Special Controls Guidance Document for knee joint patellofemorotibial and femorotibial metal/polymer porous-coated uncemented prostheses. ## Technological Characteristics Material: Co-Cr-Mo alloy. Design: Tibial tray with shortened stem for minimally invasive access. Application: Cemented. Regulatory Class: II. Product Code: JWH. Standard: Complies with Class II Special Controls Guidance Document for Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses. ## 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). ## Predicate Devices - Interlok® Primary Tibial Trays ([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}------------------------------------------------ K063732 Image /page/0/Picture/1 description: The image shows the word "BIOMET" in a stylized, blocky font. Each letter is enclosed within a rectangular or square shape, creating a bold and geometric appearance. The letters are white against a black background, which emphasizes the word and makes it stand out. 510(k) Summary JAN 1 8 2007 Preparation Date: December 15, 2006 Applicant/Sponsor: Biomet Manufacturing Corp. Contact Person: Becky Earl Regulatory Specialist Proprietary Name: Biomet® Microplasty Tibial Tray Common Name: Knee prosthesis (tibial tray) Classification Code/Name: JWH-Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (888.3560) ## Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Interlok® Primary Tibial Trays - K915132 Device Description: Biomet® Microplasty Tibial Trays are designed to hold the tibial knee bearings in a microplasty knee procedure. The Co-Cro-Mo trays are designed with a shorter stem to allow for easier insertion through a minimally invasive incision. ## Indications for Use: - 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. - 2. Correction of varus, valgus, or posttraumatic deformity. - 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous ioint replacement procedure. Non-coated (Interlok®) devices are indicated for cemented application only. Summary of Technologies: The Biomet® Microplasty Tibial Trays are technologically similar to the predicate devices. The changes include material, stem length, modularity and slight changes to the locking bar. Non-Clinical Testing: All parameters of the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses" that applied to the tibial components in this 510(k) were met. Clinical Testing: Clinical testing was not conducted in support of substantial equivalence. All trademarks are property of Biomet, Inc. MAILING ADDRESS SHIPPING ADDRESS P.O. Box 587 56 E. Bell Drive Warsaw, IN 46581 0587 Warsaw, IN 46581 0587 Wasaw, IN 46582 OFFICE FAX E-MAIL 플 흥 574.267.66.39 574.267.8137 biomet@biomet.com {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 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, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Biomet Orthopedics, Inc. % Ms. Becky Earl P.O. Box 587 Warsaw, Indiana 46581-0587 JAN 1 8 2007 Re: K063732 Trade/Device Name: Biomet® Microplasty Tibial Trays Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: December 15, 2006 Received: December 18, 2006 Dear Ms. Earl: 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. {2}------------------------------------------------ Page 2 - Ms. Becky Earl 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Joubare Anelin Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K O6 3 7 3 Z Device Name: Microplasty Tibial Trays Indications for Use: - 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. - 2. Correction of varus, valgus, or posttraumatic deformity. - 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Non-coated (Interlok®) devices are indicated for cemented application only. Prescription Use _ YES_ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ NO (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) lurbare brumP Division Sign Off Division of General, Restorative, and Nevrological Devices **510(k) Number** K063232 Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K063732](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K063732) **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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