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.

Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic 1. arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. 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 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

Device Description

The subject Vanguard XP Knee System line extension introduces the 59mm XP-XP Tibial Tray, modifications to corresponding 59mm XP-XP and XP-AS bearings, implant-specific instrumentation, differential bearing (thickness and/or articulation) compatibility and MR conditional labeling for the system.

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 manufactured of Co-Cr-Mo (with locking bar), and dual bearings machined of E1 poly. Biomet patellae can be used with the Vanguard XP Knee System. The subject Vanguard XP-XP tibial components are available in Biomet's Interlok coarse blasted finish for cemented fixation.

AI/ML Overview

This document is a 510(k) premarket notification for the "Vanguard XP Knee System". It focuses on a line extension, specifically the introduction of a 59mm XP-XP Tibial Tray and related components. The document describes the device, its intended use, and provides a summary of performance data (non-clinical tests) used to demonstrate substantial equivalence to existing predicate devices.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics in the way one might expect for a new artificial intelligence (AI) device. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the performance of the new device (Vanguard XP Knee System line extension) is comparable or equivalent to the predicate devices.

Test Category	Specific Test	Implied Acceptance Criteria (relative to predicate)	Reported Device Performance (Summary)
Mechanical Performance	Wear	Comparable wear characteristics	Non-clinical performance testing completed to support substantial equivalence. (Specific results not detailed in this summary)
	Contact Area	Comparable contact area	Non-clinical performance testing completed to support substantial equivalence. (Specific results not detailed in this summary)
	Constraint	Comparable constraint characteristics	Non-clinical performance testing completed to support substantial equivalence. (Specific results not detailed in this summary)
	Tibiofemoral Stability Locking mechanism test	Acceptable locking mechanism stability	Non-clinical performance testing completed to support substantial equivalence. (Specific results not detailed in this summary)
	Tibial Tray fatigue Test	Acceptable fatigue life	Non-clinical performance testing completed to support substantial equivalence. (Specific results not detailed in this summary)
	Bearing Micromotion Analysis/Cyclic Locking Mechanism Test	Acceptable micromotion and locking mechanism performance	Non-clinical performance testing completed to support substantial equivalence. (Specific results not detailed in this summary)
Magnetic Resonance (MR) Compatibility	RF heating (ASTM F2182-11a)	Meet MR Conditional requirements	Determined to be MR Conditional in accordance with ASTM F2503-13. (CEM43 analysis also mentioned)
	Image Distortion (ASTM F2119-07)	Meet MR Conditional requirements	Determined to be MR Conditional in accordance with ASTM F2503-13.
	Magnetically Induced Displacement Force (ASTM 2052-14)	Meet MR Conditional requirements	Determined to be MR Conditional in accordance with ASTM F2503-13.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical study or a study involving a "test set" of patient data in the context of an AI device. The "tests" described are non-clinical (mechanical and MR compatibility) and would involve physical devices or components, not a patient data set. Therefore, sample sizes for a test set and data provenance (country, retrospective/prospective) are not applicable or provided in this document as it pertains to a traditional medical device, not an AI/software device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a knee implant, not an AI diagnostic or prognostic tool. "Ground truth" in the context of expert consensus on patient data is not relevant to the non-clinical mechanical testing and MR compatibility testing described.

4. Adjudication Method

Not applicable, as this is not a study involving expert review or a patient data test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a traditional medical device (knee implant) premarket notification, not an AI device. An MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study

No. This document is for a physical medical device (knee implant), not an algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests described would be based on established engineering principles, material science standards (e.g., ASTM standards for MR compatibility, fatigue testing), and comparison to the performance of legally marketed predicate devices. The "truth" is determined by whether the device meets specific physical and performance characteristics as defined by these standards and comparison.

8. Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 10, 2016

Biomet, Incorporated Ms. Julie Gantenberg Senior Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581

Re: K153657 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 Code: MBH, OIY, JWH, MBV Dated: April 12, 2016 Received: April 14, 2016

Dear Ms. Gantenberg:

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 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education at its toll-free 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" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K153657

Device Name

Vanguard XP Knee System

Indications for Use (Describe)

Painful and disabled knee joint resulting from osteoarthritis, or traumatic 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 biological fixation application. Non-coated (Interlok) femoral components and all polyethylene patellar components are indicated for cemented application only. Regenerex components* are intended only for uncemented biologic fixation application.

*Where Available

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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BIOMET

510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Vanguard XP Knee System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Biomet, Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Phone Number: (574) 267-6639Fax Number: (574) 372-4710Establishment Registration Number: 1825034
Contact:	Julie B. Gantenberg, M.S., RACRegulatory Affairs Project Manager
Date:	April 27, 2016
Subject Device:	Trade Name: Vanguard XP Knee SystemCommon Name: Knee Prosthesis
Product Code-Classification Name:	MBH - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (21 CFR§888.3565) JWH - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (21 CFR §888.3560) MBV - Knee joint patellofemorotibial semi-constrained UHMWPE pegged uncemented polymer/metal/polymer (21 CFR §888.3560) OIY - Knee joint patellofemorotibial polymer +Additive/metal/polymer +Additive semi-constrained cemented prosthesis (21 CFR §888.3560)

Legally marketed devices to which substantial equivalence is claimed:

K141407/K132873/K122160 Vanguard XP Knee System
K113550 Vanguard Knee System ●
K904448 Townley Total Knee

Reference Devices for Differential Bearings:

K094050 ConforMIS iTotal Cruciate Retaining Knee Replacement system iTotal KRS ●
K092201 ADVANCE 913 Medial Pivot Tibial Insert, ADVANCE 913 Medial Pivot Tibial Base

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Vanguard XP Knee System | Traditional

Device Description

Intended Use and Indications for Use

Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic 1. arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.

*where available

Summary of Technological Characteristics

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 device systems (K141407, K113550 and K904448) in terms of design, material, and principle of operation with the exception of modifications as described in this 510(k). The 59mm XP-XP tray size and corresponding XP bearings are a line addition to the Vanguard XP Knee System and uses the identical manufacturing processes as the predicates. Non-clinical performance testing completed to support substantial equivalence is listed below.

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BIOMET

Summary of Performance Data (Nonclinical and/or Clinical):

Non-Clinical Tests:

Wear O
Contact Area O
Constraint O
Tibiofemoral Stability Locking mechanism test O
Tibial Tray fatigue Test O
O Bearing Micromotion Analysis/Cyclic Locking Mechanism Test
MR Testing O

Biomet has performed non-clinical Magnetic Resonance Imaging (MRI) studies on Vanguard Knee implants which are determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Tests included the following:

RF heating- ASTM F2182-11a Image Distortion- ASTM F2119-07 Magnetically Induced Displacement Force - ASTM 2052-14 CEM43 analysis

Clinical Tests:

O None provided as a basis for substantial equivalence.

Substantial Equivalence Conclusion

The proposed Vanguard XP devices have the same intended use and indications for use as the predicate devices. Performance test data and analyses demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.

Regulation Number and Section

§ 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.