(89 days)
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:
- I. 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.
-
- 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
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Biomet Vanguard™ XP Knee System:
Device: Biomet Vanguard™ XP Knee System
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (K132873) focuses on a modification to the locking mechanism of an already cleared knee system. As such, the acceptance criteria are not explicitly numerical performance targets in the sense of a new device's efficacy, but rather a demonstration that the modification does not adversely affect safety and maintains substantial equivalence to predicate devices. The "reported device performance" is essentially that all tests met or exceeded established acceptance criteria, confirming this non-adverse effect.
| Acceptance Criteria Category | Specific Test/Rationale | Reported Device Performance |
|---|---|---|
| Mechanical Stability & Functionality | Tibiofemoral Mechanical Stability / Locking Mechanism Test | Met or exceeded established acceptance criteria |
| Static Locking Mechanism Test | Met or exceeded established acceptance criteria | |
| Tibial Fixation and Cyclic Locking Mechanism Test | Met or exceeded established acceptance criteria | |
| Cyclic Fatigue of Tibial Tray Test | Met or exceeded established acceptance criteria | |
| Tibial/Bearing Assembly Verification Test | Met or exceeded established acceptance criteria | |
| Locking Bar Insertion and Push-Out Test | Met or exceeded established acceptance criteria | |
| Material & Compatibility | MRI Compatibility Rationale | Demonstrated MRI compatibility (based on rationale, not explicit testing results in this summary) |
| Porous plasma spray characterization data (on identical substrate) | Used from K113550, supporting K122160 and the current 510(k), indicating established performance |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (e.g., number of components tested) for each non-clinical test. It only states that the tests were performed.
- Data Provenance: The data is from non-clinical testing (mechanical tests). The origin country is not explicitly stated, but given the submitter and FDA context, it is presumed to be conducted under standards relevant to the US market. The nature of the study is purely retrospective in the sense that it's testing a modified device against established standards and predicate data, not a de novo prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This submission relies on non-clinical mechanical testing, not expert-reviewed clinical data or images. The "ground truth" for these tests is the performance against pre-defined engineering and mechanical standards.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this is non-clinical mechanical testing, not a clinical study involving human readers or adjudication. The results are quantitative measurements against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This document explicitly states: "No clinical testing was necessary for a determination of substantial equivalence." Therefore, no MRMC study was conducted. The nature of this submission is a modification to a previously cleared device, relying on non-clinical testing to demonstrate that the modification does not introduce new safety or effectiveness concerns.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This is a physical prosthetic device (a knee system), not an algorithm or AI-based device. "Standalone performance" in this context would refer to the mechanical performance of the device components themselves, which was assessed through non-clinical testing.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical tests is based on:
- Pre-defined engineering standards and mechanical test protocols (e.g., for fatigue, stability, locking mechanism integrity).
- Performance data from legally marketed predicate devices (K122160, K113550, K904448), to which substantial equivalence is claimed.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context. The manufacturing processes and design principles are based on established engineering practices and predicate devices.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set." The design and manufacturing of the device were established through conventional engineering and medical device development processes, drawing upon existing knowledge, materials science, and the performance characteristics of predicate devices.
{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 DriveWarsaw, IN 46581-0857 |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| EstablishmentRegistration Number | 1825034 |
| Name of contactperson | Julie B. Gantenberg, M.S. |
| Date prepared | September 5, 2013 |
| Name of device | |
| Trade or proprietaryname | Vanguard™ XP Knee System |
| Common or usualname | Knee Prosthesis |
| Classification name | Knee joint patellofemorotibial metal/polymer porous- coateduncemented prosthesis (§888.3565)Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (§888.3560)Knee joint patellofemorotibial semi-constrained UHMWPEpegged 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 §888.356521CFR §888.3560 |
| Product Code(s) | JWH, MBH, MBV, OIY |
| Legally marketed device(s)to which equivalence isclaimed | 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 XPSystem |
| Device description | The purpose of the submission is to update the lockingmechanism cleared in K122160. |
| The Vanguard XP Knee System is a total knee replacementsystem 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 KneeSystem. Both the XP femoral and the XP-CR tibial componentsare available with a previously cleared porous plasma spray (PPS)coating of titanium alloy and Biomet's Interlok coarse blastedfinishes. The Vanguard XP-XP tibial components are availablein Biomet's Interlok® coarse blasted finish. Porous coatedfemoral and tibial components are indicated for cemented anduncemented biological fixation application. Non-coated coarseblasted (Interlok®) femoral and tibial components are indicatedfor cemented application only. Accessory components areavailable including removable femoral pegs and femoralaugments. | |
| Intended use of the device | The Vanguard™ XP Knee System is intended for replacement of atotal knee joint and the preservation of the anterior and/or posteriorcruciate ligament (ACL/PCL) when used in conjunction with afemoral, tibial and patellar component. |
| Indications for use | 1. Painful and disabled knee joint resulting from osteoarthritis,rheumatoid arthritis, or traumatic arthritis where one or morecompartments 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 porouscoatings are indicated for cemented and uncemented biologicalfixation application. Non-coated (Interlok") femoral components.tibial tray components and all polyethylene patellar components areindicated 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.
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- 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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
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.(b)
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.