Painful and disabled knee joint resulting from osteoarthritis 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®) devices and all polyethylene patellar components are indicated for cemented application only.

Device Description

The Vanguard® Complete Knee System is a total knee replacement system for either primary or revision knee arthroplasty. It is modular in design consisting of five components: a cobalt-chromium-molybdenum (Co-Cr-Mo) or Titanium (Ti) alloy femoral component, with either a porous plasma spray (PPS) or Interlok® surface finish; a cobalt-chromium-molybdenum (Co-Cr-Mo) or Titanium (Ti) alloy tibial tray; a patellar component, manufactured from polyethylene (UHMWPE); a locking bar, manufactured from a Titanium (Ti) alloy; and tibial bearings, manufactured from a Vitamin-E Highly Crosslinked polyethylene (VEHXPE).

AI/ML Overview

This is a 510(k) premarket notification for the Vanguard Complete Knee System, a medical device. This document focuses on the claim of substantial equivalence to predicate devices rather than providing a study where the device meets specific acceptance criteria in the way an AI/software device would.

Therefore, the requested information elements related to algorithms, ground truth, expert adjudication, MRMC studies, and sample sizes for training/test sets are not applicable to this type of medical device submission.

Here's a breakdown of what is available in the document regarding the device's characteristics and the basis for its clearance:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria or reported device performance in the format of a clinical study with metrics like sensitivity, specificity, or accuracy. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices.

The "performance data" provided relates to non-clinical engineering analysis and material characteristics to show that modifications do not adversely affect safety and efficacy.

Characteristic	Predicate Comparison	Result/Finding
Materials	Identical to Persona® Personalized Knee System	Vivacit-E material characteristics presented in MAF-1868. Material and dimensional comparison of Vivacit-E to E1 tibial bearings was performed.
Design Features	Similar to Vanguard® Complete Knee System	Evaluation of stress in manufacturing slots of Vivacit-E tibial bearings using finite element analysis (FEA).
Intended Use	Identical to predicates	Met
Indications for Use	Identical to Vanguard® Complete Knee System	Met
Sterilization	Identical to Persona® Personalized Knee System	Laser etching of Vanguard Vivacit-E material. Pyrogenicity Testing.
Safety & Effectiveness	-	Engineering analysis conducted to demonstrate modifications did not adversely affect safety and efficacy. Magnetic resonance imaging (MRI) compatibility testing performed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes a physical medical device (knee implant components) and its clearance is based on substantial equivalence, primarily through non-clinical bench testing and material comparisons, not AI/software performance studies.
The "test reports" mentioned (e.g., Vivacit-E material characteristics, FEA evaluation, MRI compatibility, Pyrogenicity Testing) refer to engineering and biocompatibility evaluations, not clinical trials with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. See point 2.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 2.

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. See point 2.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. See point 2.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this device's clearance is established through engineering principles, material science standards, and comparison to existing, legally marketed predicate devices. For example, material strength might be compared to industry standards or predicate device specifications, which serves as the "ground truth" for material performance.

8. The sample size for the training set

Not applicable. See point 2.

9. How the ground truth for the training set was established

Not applicable. See point 2.

Summary of the K183583 Submission:

Device: Vanguard® Complete Knee System (specifically, modifications to the tibial bearings).
Purpose of Submission: To introduce a modification to the tibial bearings within the existing Vanguard® Complete Knee System.
Basis for Clearance: Substantial Equivalence to legally marketed predicate devices.
Key Argument for Substantial Equivalence:
- Identical Intended Use and Indications for Use as predicates.
- Similar Technological Characteristics to predicates (materials, design features, sterilization).
- Non-Clinical Testing: Engineering analyses, material characteristic evaluations (Vivacit-E material characteristics, material and dimensional comparison, FEA for stress evaluation), laser etching analysis, MRI compatibility, and pyrogenicity testing were conducted.
- Clinical Testing: "Clinical data was not deemed necessary for the subject device." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical means.

The document concludes that the differences introduced by the modification "do not raise new questions of safety and effectiveness" and that "the proposed device is at least as safe and effective as the legally marketed predicate devices."

Summary

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May 10, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

Zimmer Inc. Charles Neitzel Senior Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K183583

Trade/Device Name: Vanguard Complete 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, MBH, OIY Dated: April 4, 2019 Received: April 5, 2019

Dear Charles Neitzel:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 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/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CAPT Raquel Peat, PhD, MPH, USPHS FOR Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K183583

Device Name

Vanguard Complete Knee System

Indications for Use (Describe)

Painful and disabled knee joint resulting from osteoarthritis 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K183583 - Page 1 of 3

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

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® Complete 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:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Charles NeitzelSenior Specialist, Regulatory AffairsTelephone: (262) 716-3243Fax: (574) 372-4605
Date:	December 21, 2018
Trade Name:	Vanguard® Complete Knee System
Common Name:	Knee Bearing
Classification Namesand References:	JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560)MBH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Uncemented, Porous Coated, Polymer/Metal/Polymer (21 CFR 888.3565)OIY – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (21 CFR 888.3560)
Classification Panel:	Orthopedics/87
Predicate Device(s):	Design Predicates: Vanguard® CR Knee System, manufactured by Biomet, K023546, cleared 01/17/2003Vanguard® PS+ Knee System, manufactured by Biomet, K041046, cleared 05/21/2004Vanguard® AS Tibial Bearings, manufactured by Biomet, K050222, cleared 08/16/2005E1 Tibial Components (previously E-poly), manufactured by Biomet, K080528, cleared 06/17/2008

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Vanguard® Complete Knee System, manufactured by Biomet, K113550, cleared 02/29/2012

Material Predicate:

Persona® Personalized Knee System. manufactured by Zimmer, K121771, cleared 11/07/2012
Persona® Personalized Knee System, manufactured by Zimmer, K150090, cleared 05/20/2015

The purpose of this subject 510(k) is to introduce a modification to the tibial bearings within the Vanguard® Complete Knee System. There are no changes to the other components within the system.

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:
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®) devices and all polyethylene patellar components are indicated for cemented application only.

Purpose and Device Description:

Intended Use:

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Summary of Technological Characteristics:

Summarv of Performance Data (Nonclinical and/or Clinical)

· Materials: Identical to the Persona Personalized Knee System predicate

· Design Features: Similar to the Vanguard Complete Knee System predicate
The rationale for substantial equivalence is based on

· Intended Use: Identical to the predicates · Indications for Use: Identical to the Vanguard

Complete Knee System predicate

consideration of the following characteristics:

· Sterilization: Identical to the Persona Personalized Knee System predicate

. Non-Clinical Tests:

Engineering analysis was conducted to demonstrate that the modifications did not adversely affect safety and efficacy, and to demonstrate substantial equivalence to the predicate components. The test reports are listed below:

o Vivacit-E material characteristics presented in MAF-1868
o Material and dimensional comparison of Vivacit-E to E1 tibial bearings
0 Evaluation of stress in manufacturing slots of Vivacit-E tibial bearings use finite element analysis
o Laser etching of Vanguard Vivacit-E material
o Magnetic resonance imaging (MRI) compatibility
o Pyrogenicity Testing
Clinical Tests:
- o Clinical data was not deemed necessary for the subject device.

The subject device has the same intended use and indications for use as the Vanguard Complete Knee System predicate device. The subject device has similar technological characteristics to the predicates, and the performance data and analyses demonstrate that:

any differences do not raise new questions of safety ● and effectiveness; and
the proposed device is at least as safe and effective as o the legally marketed predicate devices.

Substantial Equivalence Conclusion

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.