← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K110362 # VANGUARD ASYMMETRICAL PATELLAR COMPONENT (K110362) _Biomet Manufacturing Corp · JWH · Feb 28, 2011 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K110362 ## Device Facts - **Applicant:** Biomet Manufacturing Corp - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Feb 28, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Vanguard® Asymmetrical Patellar is intended for replacement of part of the knee joint in conjunction with a femoral and tibial component. 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 total joint replacement procedure. Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only. ## Device Story Vanguard® Asymmetrical Patellar Component is a knee prosthesis component; machined from UHMWPE (ASTM F-648). Used in total knee arthroplasty; functions as a bearing surface in conjunction with femoral and tibial components. Designed for cemented application. Intended to restore joint function; alleviate pain; correct deformities. Operated by orthopedic surgeons in clinical/surgical settings. Output is a physical prosthetic interface; clinical decision-making based on patient anatomy and joint pathology. ## Clinical Evidence No clinical data provided. Substantial equivalence determined via non-clinical bench testing, including patellofemoral stability, contact area analysis, and peg shear area analysis, comparing the subject device to predicate performance requirements. ## Technological Characteristics Material: UHMWPE conforming to ASTM F-648. Design: Asymmetrical or medialized dome. Dimensions: 25, 28, 31 x 8 mm; 34 x 8.5 mm; 37, 40 x 10 mm. Application: Cemented only. No electronic components or software. ## 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 - Vanguard Patellar Components ([K040770](/device/K040770.md)) - Scorpio X3 UHMWPE Patellar Components ([K051977](/device/K051977.md)) ## Reference Devices - [K921182](/device/K921182.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}------------------------------------------------ K110362 FEB 2 8 2011 Image /page/0/Picture/2 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized, blocky font with a small trademark symbol in the upper right corner. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. 21 CFR 807.92 | Submitter Information | | |------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Biomet Manufacturing Corp. | | Address | 56 East Bell Drive
Warsaw, IN 46581-0857 | | Phone number | (574) 267-6639 | | Fax number | (574) 371-1027 | | Establishment
Registration Number | 1825034 | | Name of contact
person | Tamara West | | Date prepared | February 4, 2011 | | Name of device | | | Trade or proprietary
name | Vanguard® Asymmetrical Patellar Component | | Common or usual
name | Knee Prosthesis | | Classification name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (21CFR §888.3560) | | Classification panel | Orthopedic | | Regulation | 21CFR §888.3560 | | Product Code(s) | JWH | | Legally marketed
device(s) to which
equivalence is claimed | K040770 Vanguard Patellar Components
K051977 Scorpio X3 UHMWPE Patellar Components | | Reason for 510(k)
submission | Addition of asymmetrical designed patella to the Vanguard® product line | | Device description | The Vanguard® Patellar Component is machined of polyethylene (UHMWPE) conforming to ASTM F-648. | | Intended use of the
device | The Vanguard® Asymmetrical Patellar is intended for replacement of part of the knee joint in conjunction with a femoral and tibial component. | | Indications for use | 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or more compartments are involved. | 0. Box 56 p. 1 of 3 {1}------------------------------------------------ # KII0362 BIOMET® MANUFACTURING CORP. 2. Correction of varus, valqus, or posttraumatic deformity: 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure. Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (Interlok(8) devices and all polyethylene patellar components are indicated for cemented application only. Summary of the technological characteristics of the device compared to the predicate | Characteristic | New Device | Predicate | |------------------------|------------------------------------------------------|-------------------| | Design | Asymmetrical or medialized
dome | K051977 & K040770 | | Material | UHMWPE | K040770 | | Principal of operation | Primary replacement of a
total knee joint | K040770 | | Dimensions | 25, 28 & 31 x 8 mm
34 x 8.5 mm
37 & 40 x 10 mm | K040770 | #### PERFORMANCE DATA ### SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE Performance Test Summary-New Device The Vanguard® Asymmetrical Patellar component has the same technological characteristics as the predicate devices except for a slight modification to the general design as described in this 510(k) notification. A risk analysis was conducted along with an engineering rationale to demonstrate equivalence of the subject products to the predicate devices. #### Comparative Performance Information Summary | Characteristic | Requirement | New Device | Predicate Device | |-----------------------------|---------------------------|------------|------------------| | Patellofemoral
Stability | Meet or exceed parameters | Meet | K921182 | | Contact Area
Analysis | Meet or exceed parameters | Meet | K921182 | | Peg Shear Area
Analysis | Meet or exceed parameters | Meet | K040770 | PO Box 587 Warsaw. IN 46081-0557 Toll Free: 800.348.9500 Oficer 574 257,683 Main F74.2878137 wwww.bmet.an . 2 of 3 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized font, with the words "MANUFACTURING CORP." printed below. The font is blocky and sans-serif, and the letters are outlined in black. # SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION Clinical Performance Data/Information: N/A CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA No clinical testing was necessary for a determination of substantial equivalence. The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices. PO Box 587 Warsaw, IN 46081-000? Toll Free: 800 348.9000 Offor: 574 257.6833 Main Fax: 574.287.8137 www.comet.axn p. 3 of 3 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three wing-like shapes above a wavy base, all rendered in black. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Biomet Inc. % Ms. Tamara West Senior Regulatory Affairs Specialist 56 East Bell Drive, POB 587 Warsaw, Indiana 46581-0587 FEB 2 8 201 Re: K110362 Trade/Device Name: Vanguard® Asymmetrical Patellar components 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: February 04, 2011 Received: February 08, 2011 Dear Ms. West: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {4}------------------------------------------------ Page 2 - Ms. Tamara West 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, yours, Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number (if known):_ k1/0362 Device Name: Vanguard® Asymmetrical Patella Indications For Use: The Vanguard® Asymmetrical Patella is intended for replacement of part of the knee joint in conjunction with a femoral and tibial component. 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 total joint replacement procedure. Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (interlok) devices and all polyethylene patellar components are indicated for cemented application only. Prescription Use × (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) M. Melker (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices Page 1 of 1 510(k) Number K110362 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K110362](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K110362) **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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