(98 days)
Not Found
No
The document describes a mechanical knee replacement system and its components, with no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a knee replacement system used in total knee arthroplasty, which is a surgical procedure to replace a damaged knee joint, not a therapeutic device that provides therapy or treatment itself.
No
The device is a knee replacement system intended for total knee arthroplasty, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it is a "total knee replacement system comprised of a series of femoral and tibial components (bearings and trays)" and mentions "optional auxiliary components, including stem extensions, offset adaptors, and tibial and femoral augments," which are all hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a surgical implant for total knee arthroplasty, addressing issues like pain, deformity, and failed previous procedures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details components of a knee replacement system (femoral and tibial components, augments, stem extensions, etc.), which are physical implants used in surgery.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information for diagnosis, monitoring, or screening.
- Using reagents or analytical methods.
The device is a medical device, specifically a surgical implant, but it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The subject devices are intended for use in total knee arthroplasty.
Indications for use are as follows:
- 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.
The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.
The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.
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 and OsseoTi components are intended only for uncemented biologic fixation application.
The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral components. The Vanguard DA 360 components are not approved for sale in the United States or Canada.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBV
Device Description
The Vanguard 360 Revision Knee System is a total knee replacement system intended for use in primary or revision total knee joint arthroplasty. The system is comprised of a series of femoral and tibial components (bearings and trays) designed to work in conjunction with patella components and optional auxiliary components, including stem extensions, offset adaptors, and tibial and femoral augments. This submission includes a modification to the screw hole location in the 57.5mm Vanguard 360 Posterior Femoral Augments and a subcomponent design and material change in the Vanguard 360 Bowed Stem Extension Trials.
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
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
. Tolerance Analysis Report Vanguard 360 57.5mm Posterior Femoral Augments o
. o Vanguard 360 57.5mm Posterior Femoral Augments Fit Evaluation
. Pull Force Comparison Bowed Stem Trials o
Clinical Tests
. o Clinical data was not required to establish substantial equivalence between the subject and predicate devices.
Performance data has demonstrated that the proposed devices are at least as safe and effective as the legally marketed predicate device.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, interconnected design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2015
Biomet, Incorporated Mr. Jason Heckaman Regulatory Affairs Project Manager 56 East Bell Drive Warsaw, Indiana 46581
Re: K143192
Trade/Device Name: Vanguard 360 Revision Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBV Dated: January 13, 2015 Received: January 14, 2015
Dear Mr. Heckaman:
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
1
Page 2 - Mr. Jason Heckaman
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K143192
Device Name: Vanguard 360 Revision Knee System
INDICATIONS FOR USE:
-
- 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.
The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.
The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.
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 and OsseoTi components are intended only for uncemented biologic fixation application.
The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral components. The Vanguard DA 360 components are not approved for sale in the United States or Canada.
Prescription Use |X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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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 360 Revision 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
Establishment Registration Number: 1825034 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jason Heckaman
Project Manager, Regulatory Affairs
Phone: 574-371-3707
Fax: 574-372-1683 |
| Date: | November 5, 2014 |
| Subject Device: | Trade Name: Vanguard 360 Revision Knee System
Common Name: Knee Prosthesis
Classification Name:
• JWH – prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (21 CFR §888.3560)
• MBV–prosthesis, knee, patellofemorotibial, semi-constrained, UHMWPE. Pegged.cemented, polymer/metal/polymer (21 CFR |
Legally marketed devices to which substantial equivalence is claimed:
888.3560)
- K093293 Vanguard 360 Revision Knee System ●
Device Description
The Vanguard 360 Revision Knee System is a total knee replacement system intended for use in primary or revision total knee joint arthroplasty. The system is comprised of a series of femoral and tibial components (bearings and trays) designed to work in conjunction with patella components and optional auxiliary components, including stem extensions, offset adaptors, and tibial and femoral augments. This submission includes a modification to the screw hole location in the 57.5mm Vanguard 360 Posterior Femoral Augments and a subcomponent design and material change in the Vanguard 360 Bowed Stem Extension Trials.
Intended Use and Indications for Use
The subject devices are intended for use in total knee arthroplasty.
Indications for use are as follows:
4
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-
- 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.
The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.
The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.
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 and OsseoTi components are intended only for uncemented biologic fixation application.
The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral components. The Vanguard DA 360 components are not approved for sale in the United States or Canada.
Summary of Technological Characteristics
The subject changes include a change in the screw hole location in the subject augments and a change to incorporate a 416 SST cylindrical pin subcomponent in the subject trials.
The subject augments have similar technological characteristics as the predicate. There are no changes to the augment materials, shape, sizes, thicknesses, method of attachment to the femoral components, sterilization method, or shelf life.
The subject bowed stem extension trials also have similar characteristics as the existing trials. There are no changes to the shape or sizes available and the materials of the stem, barrel, and shaft are unchanged (Ti-6Al-4V and 17-4PH SST). Like the existing trials, the subject stem trials will be provided nonsterile.
Performance data has demonstrated that the proposed devices are at least as safe and effective as the legally marketed predicate device.
Summary of Performance Data (Nonclinical and/or Clinical)
- . Non-Clinical Tests
- Tolerance Analysis Report Vanguard 360 57.5mm Posterior Femoral Augments o
- o Vanguard 360 57.5mm Posterior Femoral Augments Fit Evaluation
- Pull Force Comparison Bowed Stem Trials o
- Clinical Tests ●
- o Clinical data was not required to establish substantial equivalence between the subject and predicate devices.
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Substantial Equivalence Conclusion
Based on the similarities in design, function, intended use and fundamental scientific technology, the devices that are the subject of this submission are similar to the predicate devices and do not introduce any new risks of safety or efficacy. Therefore, Biomet concludes that the subject devices are substantially equivalent to the predicate devices.