← Product Code [MBH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH) · K132873 # VANGUARD XP KNEE SYSTEM (K132873) _Biomet, Inc. · MBH · Dec 11, 2013 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K132873 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [MBH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH.md) - **Decision Date:** Dec 11, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3565 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Vanguard™ XP Knee System is intended for replacement of a total knee joint and the preservation of the anterior and/or posterior cruciate ligament (ACL/PCL) when used in conjunction with a femoral, tibial and patellar component. ## Device Story Vanguard XP Knee System is a total knee replacement prosthesis; consists of Co-Cr-Mo femoral components, Co-Cr-Mo tibial trays with locking bars, and UHMWPE bearings. System includes optional removable femoral pegs and augments. Used in orthopedic surgery to replace knee joints while preserving ACL/PCL. Components available with porous plasma spray (PPS) titanium alloy coating for cemented/uncemented biological fixation or Interlok coarse blasted finish for cemented application only. Surgeon implants device during total knee arthroplasty to restore joint function and alleviate pain. Device provides mechanical stability and articulation for the knee joint. ## Clinical Evidence No clinical testing was conducted. Substantial equivalence was established through non-clinical bench testing, including tibiofemoral mechanical stability, static and cyclic locking mechanism tests, cyclic fatigue of the tibial tray, and tibial/bearing assembly verification. All testing met or exceeded established acceptance criteria. ## Technological Characteristics Materials: Co-Cr-Mo alloy, UHMWPE, titanium alloy (porous plasma spray). Substrate: ASTM F75. Components: Femoral, tibial trays, bearings, patellae. Fixation: Cemented or uncemented (porous coated). Connectivity: None. Sterilization: Not specified. Software: None. ## Regulatory Identification A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate. ## Special Controls *Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance. ## Predicate Devices - Vanguard® XP Knee System ([K122160](/device/K122160.md)) - Vanguard™ Knee System ([K113550](/device/K113550.md)) - Townley Total Knee ([K904448](/device/K904448.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}------------------------------------------------ K132873 (1/3) Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in large, bold, sans-serif font, with a line above the letters "ET". Below the logo is the text "MANUFACTURING CORP." in a smaller, sans-serif font. The text is left-aligned and the image is in black and white. DEC 1 1 2013 ## 510(k)SUMMARY A summary of 510(k) safety and effectiveness information in accordance with the requirements of 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 | Julie B. Gantenberg, M.S. | | Date prepared | September 5, 2013 | | Name of device | | | Trade or proprietary
name | Vanguard™ XP Knee System | | Common or usual
name | Knee Prosthesis | | Classification name | Knee joint patellofemorotibial metal/polymer porous- coated
uncemented prosthesis (§888.3565)

Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis (§888.3560)

Knee joint patellofemorotibial semi-constrained UHMWPE
pegged uncemented polymer/metal/polymer (§888.3560)

Knee joint patellofemorotibial polymer+Additive/metal/polymer
+Additive semi-constrained cemented prosthesis (§888.3560) | | Classification panel | Orthopedic | | Regulation | 21CFR §888.3565
21CFR §888.3560 | | Product Code(s) | JWH, MBH, MBV, OIY | | Legally marketed device(s)
to which equivalence is
claimed | K1222160 Vanguard® XP Knee System (JWH, MBH, MBV, OIY)
K113550 Vanguard™ Knee System (JWH, MBH, OIY)
K904448 Townley Total Knee (JWH) | | Reason for 510(k)
submission | Modification of the locking mechanism cleared in K122160 XP
System | | Device description | The purpose of the submission is to update the locking
mechanism cleared in K122160. | | | The Vanguard XP Knee System is a total knee replacement
system that consists of a femoral component composed of Co-Cr-
Mo, two styles of tibial trays/plates manufactured of Co-Cr-Mo
(with locking bar), and dual bearings machined of El poly.
Biomet® patellae can be used with the Vanguard XP Knee
System. Both the XP femoral and the XP-CR tibial components
are available with a previously cleared porous plasma spray (PPS)
coating of titanium alloy and Biomet's Interlok coarse blasted
finishes. The Vanguard XP-XP tibial components are available
in Biomet's Interlok® coarse blasted finish. Porous coated
femoral and tibial components are indicated for cemented and
uncemented biological fixation application. Non-coated coarse
blasted (Interlok®) femoral and tibial components are indicated
for cemented application only. Accessory components are
available including removable femoral pegs and femoral
augments. | | Intended use of the device | The Vanguard™ XP Knee System is intended for replacement of a
total knee joint and the preservation of the anterior and/or posterior
cruciate ligament (ACL/PCL) when used in conjunction with a
femoral, tibial and patellar component. | | Indications for use | 1. Painful and disabled knee joint resulting from osteoarthritis,
rheumatoid arthritis, or traumatic arthritis where one or more
compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
2.
Correction or revision of unsuccessful osteotomy, arthrodesis,
3.
or failure of previous total joint replacement procedure.
Femoral components and tibial tray components with porous
coatings are indicated for cemented and uncemented biological
fixation application. Non-coated (Interlok") femoral components.
tibial tray components and all polyethylene patellar components are
indicated for cemented application only. Regenerex components*
are intended only for uncemented biologic fixation application.
*where available | Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800 348 9500 Office: 574 267.6639 Main Fax: 574 267.8137 www.biomet.com Shipping Address: onal 56 East Bell Drive Warsaw, IN 46582 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a bold, sans-serif font, with the letters connected to each other. Below the logo, the words "MANUFACTURING CORP." are printed in a smaller, sans-serif font. The text is black and the background is white. · . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized font, with the letters connected and enclosed in a rectangular shape. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The logo is black and white. The Vanguard™ XP Knee System is made up of multiple components. including: instrumentation, femoral components, several types of bearings and tibial trays. The technological characteristics of the Vanguard™ XP Knee System are the same as those of predicate devices (K122160, K904448, and K113550) in terms of design. material, and principle of operation with the exception of slight modifications as described in this 510(k). The subject locking bar mechanism. tibial and bearing components of the Vanguard™ XP Knee System utilize the identical manufacturing processes as the predicates. The previously cleared, porous plasma spray characterization data on identical substrate was provided in K113550 and used in support of K122160 and subject 510(k). The porous plasma spray coating on the ASTM F75 substrate is for both cemented and uncemented, biologic fixation. Non-clinical testing was conducted to demonstrate that the differences did not adversely affect safety and to demonstrate substantial equivalence to the predicate components. All testing met or exceeded the established acceptance criteria. This information is detailed below in the Performance (Nonclinical) section. ### 1 PERFORMANCE PERFORMANCE PERFORMANCE DATABLE SUMMARY OF NON-CLINICAL TESTS #### Performance Test Summarv-New Device The following tests/rationale were performed for the new Vanguard® XP Knee System: - Tibiofemoral Mechanical Stability / Locking Mechanism Test . - Static Locking Mechanism Test . - o Tibial Fixation and Cyclic Locking Mechanism Test - Cyclic Fatigue of Tibial Tray Test . - Tibial/Bearing Assembly Verification Test . - Locking Bar Insertion and Push-Out Test . - MRI Compatibility Rationale ### 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. {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is positioned to the right of the text, and the overall design is simple and recognizable. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 11, 2013 Biomet Manufacturing Corporation Julie B. Gantenberg, M.S. Senior Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581 Re: K132873 Trade/Device Name: Vanguard XP Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Codes: MBH, JWH, MBV, OIY Date: September 5, 2013 Received: September 13, 2013 Dear Ms. Gantenberg: We have reviewed vour 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 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 {4}------------------------------------------------ #### Page 2 - Julie B. Gantenberg, M.S. 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR 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/ReportalProblem/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 vours. # Ronaldille Nean -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K132873 Device Name: Vanguard™ XP Knee System Indications For Use: - I. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or 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 uncemented biological fixation. Non-coated (Interlok") femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application. * Where Available 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) Image /page/5/Picture/14 description: The image shows a logo with the text "Casey L. Hanley, Rh.D." on the top left. Below a horizontal line, the text "Division of Orthopedic Devices" is present. The logo also features a stylized graphic, possibly representing the letters "FDA", integrated into the design. Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K132873](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K132873) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com