(140 days)
No
The document describes a total knee replacement system and its components. There is no mention of AI, ML, image processing, or any software-based decision-making or analysis that would typically indicate the presence of AI/ML. The performance studies are engineering analyses of the physical components.
Yes
The device is a total knee replacement system intended to address painful and disabled knee joints resulting from osteoarthritis, traumatic arthritis, or for correction/revision of deformities and failed previous procedures, which are therapeutic indications.
No
Explanation: The device described is a total knee replacement system, which is a prosthetic implant used for treatment, not for diagnosing a condition.
No
The device description explicitly details physical components made of materials like cobalt-chromium-molybdenum and polyethylene, indicating it is a hardware-based medical device (a total knee replacement system).
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, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a total knee replacement system consisting of physical components (femoral component, tibial trays, bearings, patellae) designed to be implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Vanguard XP Knee System is a medical device (specifically, a surgical implant), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- 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.
Product codes
JWH, MBH, OIY, MBV
Device Description
The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of cobalt-chromium-molybdenum (Co-Cr-Mo), two styles of tibial trays manufactured out of Co-Cr-Mo (with locking bar), and dual bearings machined of Vivacit-E Vitamin-E Highly Crosslinked Polyethylene (VEHXPE). Biomet patellae can be used with the Vanguard XP Knee System. The subject Vanguard XP tibial components are available with a porous plasma spray (PPS®) of titanium alloy powder for uncemented or cemented fixation or with Biomet's Interlok coarse blasted finish for cemented fixation only. The Vanguard XP Knee System offers the flexibility to retain the ACL and PCL ligaments, retain just the PCL ligament and accommodate an intact, partially functioning PCL within a single system.
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
Not Found
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)
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:
- 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 using finite element analysis
- Laser etching of Vanguard XP Vivacit-E material
- Magnetic resonance imaging (MRI) compatibility
- Testing to establish product non-pyrogenicity
Clinical Tests:
Clinical data was not deemed necessary for the o subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K122160, K132873, K141407, K153657
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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June 4, 2019
Zimmer Inc. Charles Neitzel Senior Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K190068
Trade/Device Name: Vanguard XP 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, MBV Dated: May 7, 2019 Received: May 8, 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
1
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 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 (QS) 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,
For CAPT Raquel Peat, PhD, MPH, USPHS Director 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) K190068
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K190068 Page 1 of 4
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 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: | 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: | January 11, 2019 |
| Trade Name: | Vanguard XP 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)MBV - Prosthesis, Knee, Patello/Femorotibial, Semi-
Constrained, Uhmwpe, Pegged, Cemented,
Polymer/Metal/Polymer (21 CFR 888.3560) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Design Predicates:
Vanguard XP Knee System, manufactured by
Biomet, K122160, cleared on 03/20/2013Vanguard XP Knee System, manufactured by
Biomet, K132873, cleared on 12/11/2013Vanguard XP Femoral Component (Gen
II)/Vanguard XP Femoral Trial, manufactured by
Biomet, K141407, cleared on 10/27/2014 |
4
-
Vanguard XP Knee System, manufactured by Biomet, K153657, cleared 05/10/2016
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 XP Knee System. There are no changes to the other components within the system.
The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of cobalt-chromium-molybdenum (Co-Cr-Mo), two styles of tibial trays manufactured out of Co-Cr-Mo (with locking bar), and dual bearings machined of Vivacit-E Vitamin-E Highly Crosslinked Polyethylene (VEHXPE). Biomet patellae can be used with the Vanguard XP Knee System. The subject Vanguard XP tibial components are available with a porous plasma spray (PPS®) of titanium alloy powder for uncemented or cemented fixation or with Biomet's Interlok coarse blasted finish for cemented fixation only. The Vanguard XP Knee System offers the flexibility to retain the ACL and PCL ligaments, retain just the PCL ligament and accommodate an intact, partially functioning PCL within a single system.
-
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 application. Non-coated (Interlok) femoral components, tibial tray components
Purpose and Device Description:
Intended Use / Indications for Use:
5
and all polyethylene patellar components are indicated for cemented application only.
Summary of Technological Characteristics:
The rationale for substantial Identical equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to the predicates
- · Indications for Use: Similar to the Vanguard XP Knee System predicates
- · Materials: Identical to the Persona Personalized Knee System predicates
- · Design Features: Similar to the Vanguard XP Knee System predicates
- · Sterilization: Identical to the Persona Personalized Knee System predicates
Summary of Performance Data (Nonclinical and/or Clinical)
● 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
- o Evaluation of stress in manufacturing slots of Vivacit-E tibial bearings using finite element analysis
- o Laser etching of Vanguard XP Vivacit-E material
- o Magnetic resonance imaging (MRI) compatibility
- o Testing to establish product non-pyrogenicity
Clinical Tests: ●
- Clinical data was not deemed necessary for the o subject device.
6
Substantial Equivalence Conclusion
The subject device has the same intended use and similar indications for use as the Vanguard XP Knee System predicate devices. 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 the legally marketed predicate devices.