(141 days)
No
The document describes a total knee replacement system and its components, focusing on materials, fixation methods, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a "total knee replacement system" intended for "replacement of a total knee joint" due to various medical conditions like osteoarthritis, rheumatoid arthritis, or traumatic arthritis. These are conditions that cause pain and disability, and the replacement aims to alleviate these symptoms and restore function. Therefore, it is used to treat or manage a disease or condition, classifying it as a therapeutic device.
No
The device is a total knee replacement system and its intended use is for the replacement of a total knee joint, not for diagnosing conditions.
No
The device description clearly states it is a total knee replacement system consisting of physical components like femoral components, tibial trays, and bearings, which are hardware.
Based on the provided text, 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 knee joint due to various conditions like arthritis and deformities. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and components of a knee implant (femoral component, tibial trays, bearings, patellae). These are physical parts intended for implantation, not reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro testing, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The non-clinical tests focus on the mechanical and physical properties of the implant (wear, contact area, stability, fatigue, MR compatibility), which are relevant to the performance of a surgical implant, not an IVD.
Therefore, the Vanguard XP Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
-
- 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 and all polyethylene patellar components are indicated for cemented application only. Regenerex components* are intended only for uncemented biologic fixation application.
Product codes (comma separated list FDA assigned to the subject device)
MBH, OIY, JWH, MBV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
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:
- 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.
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.
K141407/K132873/K122160, K113550, K904448
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.
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
§ 888.3565 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.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a symbol that appears to be three faces in profile, stacked on top of each other.
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
1
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)
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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3
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 Drive
PO Box 587
Warsaw, IN 46581
Phone Number: (574) 267-6639
Fax Number: (574) 372-4710
Establishment Registration Number: 1825034 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Julie B. Gantenberg, M.S., RAC
Regulatory Affairs Project Manager |
| Date: | April 27, 2016 |
| Subject Device: | Trade Name: Vanguard XP Knee System
Common 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
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.
Intended Use and Indications for Use
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.
-
- 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 and all polyethylene patellar components are indicated for cemented application only. Regenerex components* are intended only for uncemented biologic fixation application.
*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.