VANGUARD 360 REVISION KNEE SYSTEM by BIOMET, INC.

Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 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 joint replacement procedure.
These devices are single-use implants intended for cemented use only.

Device Description

The Vanguard™ 360 Revision Knee System is a series of femoral, tibial and offset adapter components designed to work in conjunction with femoral stems, bearings, trays, augments and patella components of Biomet's previously cleared Maxim® and Vanguard™ SSK knee systems. These components can be used for either primary or revision procedures, but are specifically designed for use where there is inadequate bone stock. Biomet has developed this system in order to expand its product line for its currently marketed Vanguard™ [SSK] Knee System (K042757).
The Vanguard™ 360 femoral components are made of Co-Cr-Mo alloy and incorporate the validation features as the predicate Vanguard SSK femoral components. The tibial components incorporate the same tibial tray profile as the current Biomet Tibial Trays and the predicate Offset Tibial Tray design and are made of Ti-6A1-4V titanium alloy. The femoral and tibial components are designed for use with the Biomet knee stems cleared in the predicate MCK (Maxim ) System. A series of tibial and femoral augments made of Ti-6A1-4V titanium alloy, allow for the modularity to accommodate bone defects that may be present during revision surgeries. The Ti-6Al-4V titanium alloy Offset Adapter components in this system, allow the surgeon to offset the centerline between the stem and the femoral or tibial components throughout 360 degrees in the transverse axis. Titanium alloy Ti-6A1-4V bone screws can be used if additional screw fixation is warranted.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Vanguard™ 360 Revision Knee System." This submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish novel performance claims through clinical studies. Therefore, much of the information requested, such as sample sizes for test and training sets, expert qualifications, ground truth methods for AI, MRMC studies, and standalone algorithm performance, is not applicable to this type of regulatory submission.

Here's an breakdown of the relevant information provided and an explanation of why other requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically met through non-clinical testing demonstrating that the new device is as safe and effective as the predicate devices. The "performance" is shown by verifying that the device meets safety and functionality standards comparable to existing, legally marketed devices.

Acceptance Criteria (Non-Clinical Test Type)	Reported Device Performance
Resisting in-vivo torque: Engineering Justification regarding cylindrical Boss geometry.	Demonstrated capability to resist in-vivo torque.
Femoral Boss alignment tab removal: Engineering Justification.	Addressed the removal of the alignment tab.
80/20 Fatigue Strength: Verification testing.	All components passed testing.
Cantilever Beam Fatigue: Verification testing.	All components passed testing.
MRI Distortion: Testing according to ASTM F2119-07.	Satisfied ASTM F2119-07.
RF Heating: Testing according to ASTM F2182-09.	Satisfied ASTM F2182-09.
Magnetically Induced Displacement Force/Torque Deflection: Testing according to ASTM F2052-06e1.	Measured 5° or less in 3.0T MRI System, passed testing.
Overall MRI Compatibility: Determined according to ASTM F2503-08.	Components are MR Conditional within ASTM F2503-08 definition.

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

Not Applicable. This submission relies on non-clinical engineering and laboratory testing, not a clinical test set with patient data. The "test sets" here refer to test specimens or setups for mechanical and material property evaluations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. Ground truth in the context of this 510(k) refers to established engineering standards, material specifications, and mechanical performance requirements, not expert clinical interpretations of diagnostic data. The "experts" would be the engineers and scientists conducting the described non-clinical tests.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods are typically for clinical studies involving human interpretation or uncertain outcomes. For engineering tests, results are typically determined by established test protocols and predefined acceptance limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not Applicable. This is a medical device (knee implant) submission, not an AI/software device. No MRMC studies were performed, and AI assistance is not involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" for non-clinical testing is based on:
- Established engineering principles and calculations (e.g., for resisting in-vivo torque, and addressing the femoral boss alignment tab removal).
- Industry standards and specifications (e.g., ASTM standards for MRI compatibility tests: ASTM F2119-07, ASTM F2182-09, ASTM F2052-06e1, ASTM F2503-08).
- Pre-defined acceptance criteria for mechanical strength and fatigue tests (80/20 Fatigue Strength, Cantilever Beam Fatigue).

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device. No "training set" was used.

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

Not Applicable. As no training set was used, no ground truth needed to be established for it.

Summary

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15093293

Image /page/0/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in large, bold, block letters with a registered trademark symbol. Below that, in a smaller font, is the text "MANUFACTURING CORP."

OCT 2 2 2010

510(k) Summary

October 20, 2010 Preparation Date:

Biomet Manufacturing Corp. Applicant/Sponsor:

Contact Person: Gary Baker

Proprietary Name: VanguardTM 360 Revision Knee System

Knee prostheses Common Name:

Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis (21 CFR §888.3560)

JWH. MBV Product Codes:

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Vanguard™ SSK Knee System	K042757	Biomet
Offset Tibial Tray	K010212	Biomet
MCK [Maxim®] Knee System	K915132	Biomet

Device Description: The Vanguard™ 360 Revision Knee System is a series of femoral, tibial and offset adapter components designed to work in conjunction with femoral stems, bearings, trays, augments and patella components of Biomet's previously cleared Maxim® and Vanguard™ SSK knee systems. These components can be used for either primary or revision procedures, but are specifically designed for use where there is inadequate bone stock. Biomet has developed this system in order to expand its product Inacequate oone its currently marketed Vanguard™ [SSK] Knee System (K042757).

The Vanguard™ 360 femoral components are made of Co-Cr-Mo alloy and incorporate the valigation features as the predicate Vanguard SSK femoral components. The tibial components incorporate the same tibial tray profile as the current Biomet Tibial Trays and the predicate Offset Tibial Tray design and are made of Ti-6A1-4V titanium alloy. The femoral and tibial components are designed for use with the Biomet knee stems cleared in the predicate MCK (Maxim ) System. A series of tibial and femoral augments made of Ti-6A1-4V titanium alloy, allow for the modularity to accommodate bone defects that may be present during revision surgeries. The Ti-6Al-4V titanium alloy Offset that may be present adminis system, allow the surgeon to offset the centerline between the

Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.287.6639
Main Fax: 574.267.8137
www.biomet.com

Shipping Address:
56 East Bell Drive
Warsaw, IN 46582

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stem and the femoral or tibial components throughout 360 degrees in the transverse axis. Titanium allov Ti-6A1-4V bone screws can be used if additional screw fixation is warranted.

KO93293

Intended Use: Cemented knee replacement device

Indications for Use:

The indications for the Vanguard™ 360 Revision Knee System are as follows:

1. Painful and disabled knee joint resulting from osteoarthritis, theumatoid arthritis, traumatic 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 joint replacement procedure.

These devices are single-use implants intended for cemented use only.

Summary of Technologies: The technological characteristics (material, design and sizing) of the Vanguard™ 360 Revision Knee System are similar or identical to the predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. Based on the information provided below, there are no new issues relating to safety or effectiveness introduced.

An Engineering Justification demonstrates that the cylindrical Boss geometry is capable 1. of resisting in-vivo torque.
1. An Engineering Justification addressed the removal of the alignment tab from the femoral Boss
1. Verification testing of 80/20 Fatigue Strength demonstrated that all components passed testing.
Verification testing of Cantilever Beam Fatigue demonstrated that all components 4. passed testing.
5 MRI Distortion testing was performed according to ASTM F2119-07. RF Heating tests were conducted in accordance with ASTM F2182-09. Testing of magnetically induced displacement force or torque deflection angle was measured to be 5° or less in the 3.0T MRI System in tests performed in accordance with ASTM F2052-06e1. MRI testing of the Vanguard Knee System components determined that the Vanguard System components are MR Conditional within the definition found in ASTM F2503-08.

All trademarks are property of Biomet.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Biomet Inc. % Mr. Gary Baker Regulatory Affairs Project Manager 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581

OCT 2 2 2010

Re: K093293

Trade/Device Name: Vanguard™ 360 Revision Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBV Dated: October 18, 2010 Received: October 19. 2010

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Dear Mr. Baker:

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. Iisting 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

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Page 2 - Mr. Gary Baker

device-related adverse events) (21 CFR 803); 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.

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/CDRH/CDRHOffices/ucm115809.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 vours.

Sincerely, yours,

Barbara Buchud

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

Enclosure

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Indications for Use

510(k) Number (if known): K093293

OCT 2 2 2010

Device Name: Vanguard™ 360 Revision Knee System

The indications for the Vanguard™ 360 Revision Knee System are as follows:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or coulding from oscoarthritis, medit
1. Correction of varus, valgus, or posttraumatic deformity;
Correction or revision of each as a successful osteomity,
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total 3. joint replacement procedure.

These devices are single-use implants intended for cemented use 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)

Pelo mo Oci

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(Division Sign Oro Division of St rical, Orthopedic, and Restorative Devices

510(k) Number 10693293

Regulation Number and Section

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

(a)
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).(b)
Classification. Class II.