(140 days)
Not Found
No
The device description and performance studies focus on the materials, mechanical properties, and design of a total knee replacement system. There is no mention of AI, ML, image processing, or data-driven algorithms for diagnosis, treatment planning, or device function.
Yes
The device is a total knee replacement system used to correct painful and disabled knee joints, which directly aims to alleviate a medical condition and restore function.
No
Explanation: The device is described as a "total knee replacement system" used for surgical procedures to replace a knee joint. Its intended use and description clearly indicate it is a therapeutic/implantable device, not a diagnostic one.
No
The device description clearly outlines multiple hardware components made of various materials (cobalt-chromium-molybdenum, Titanium, polyethylene) intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a damaged knee joint. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a physical implant made of metals and polyethylene, designed to replace anatomical structures. This is consistent with a surgical device, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition based on laboratory testing.
The device is a surgical implant used to treat a condition (osteoarthritis, trauma, etc.) by replacing the damaged joint.
N/A
Intended Use / Indications for Use
- 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.
Product codes
JWH, MBH, OIY
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Vivacit-E material characteristics presented in MAF-1868
- Material and dimensional comparison of Vivacit-E to E1 tibial bearings
- Evaluation of stress in manufacturing slots of Vivacit-E tibial bearings use finite element analysis
- Laser etching of Vanguard Vivacit-E material
- Magnetic resonance imaging (MRI) compatibility
- Pyrogenicity Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K023546, K041046, K050222, K080528, K113550, K121771, K150090
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known)
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.
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.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized letter "Z" inside. Below the circle, the word "zimmer" is written in lowercase blue letters. The font used for the word "zimmer" is sans-serif and appears to be a custom design.
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 708
Warsaw, IN 46581-0708 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Charles Neitzel
Senior Specialist, Regulatory Affairs
Telephone: (262) 716-3243
Fax: (574) 372-4605 |
| Date: | December 21, 2018 |
| Trade Name: | Vanguard® Complete Knee System |
| Common Name: | Knee Bearing |
| Classification Names
and 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 |
4
- 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.
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).
-
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:
5
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.