(366 days)
No
The 510(k) summary describes a mechanical knee implant system and its components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical testing and MRI compatibility.
Yes
The device is a knee implant designed to relieve pain and correct deformities in the knee joint resulting from various conditions like osteoarthritis, rheumatoid arthritis, or failed previous joint replacements. These functions align with the definition of a therapeutic device, as it is intended to treat and alleviate a medical condition.
No
This device is a knee implant system used for surgical procedures to replace or revise knee joints, not to diagnose medical conditions.
No
The device description clearly states it is a series of physical components (femoral, tibial, offset adapter components, stems, bearings, trays, augments, patella components, bone screws) made of materials like Co-Cr-Mo alloy and Ti-6A1-4V titanium alloy, intended for surgical implantation. This is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating painful and disabled knee joints due to various conditions, correcting deformities, and revising previous procedures. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details the components of a knee replacement system (femoral, tibial, augments, stems, etc.) made of materials like Co-Cr-Mo alloy and Ti-6A1-4V titanium alloy. These are materials used for implants, not for in vitro diagnostic reagents or instruments.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on mechanical properties and MRI compatibility, which are relevant for surgical implants, not IVD devices.
In summary, the Vanguard™ 360 Revision Knee System is a surgical implant intended for therapeutic use in the knee joint, not for performing diagnostic tests outside of the body.
N/A
Intended Use / Indications for Use
The indications for the Vanguard™ 360 Revision Knee System are as follows:
-
- Painful and disabled knee joint resulting from osteoarthritis, theumatoid 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.
These devices are single-use implants intended for cemented use only.
Product codes
JWH, MBV
Device Description
The Vanguard™ 360 Revision Knee System is a series of femoral, tibial and offset adapter components designed to work in conjunction with femoral stems, bearings, trays, augments and patella components of Biomet's previously cleared Maxim® and Vanguard™ SSK knee systems. These components can be used for either primary or revision procedures, but are specifically designed for use where there is inadequate bone stock. Biomet has developed this system in order to expand its product Inacequate oone its currently marketed Vanguard™ [SSK] Knee System (K042757).
The Vanguard™ 360 femoral components are made of Co-Cr-Mo alloy and incorporate the valigation features as the predicate Vanguard SSK femoral components. The tibial components incorporate the same tibial tray profile as the current Biomet Tibial Trays and the predicate Offset Tibial Tray design and are made of Ti-6A1-4V titanium alloy. The femoral and tibial components are designed for use with the Biomet knee stems cleared in the predicate MCK (Maxim ) System. A series of tibial and femoral augments made of Ti-6A1-4V titanium alloy, allow for the modularity to accommodate bone defects that may be present during revision surgeries. The Ti-6Al-4V titanium alloy Offset that may be present adminis system, allow the surgeon to offset the centerline between the stem and the femoral or tibial components throughout 360 degrees in the transverse axis. Titanium allov Ti-6A1-4V bone screws can be used if additional screw fixation is warranted.
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 Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. Based on the information provided below, there are no new issues relating to safety or effectiveness introduced.
- An Engineering Justification demonstrates that the cylindrical Boss geometry is capable 1. of resisting in-vivo torque.
-
- An Engineering Justification addressed the removal of the alignment tab from the femoral Boss
-
- Verification testing of 80/20 Fatigue Strength demonstrated that all components passed testing.
- Verification testing of Cantilever Beam Fatigue demonstrated that all components 4. passed testing.
- 5 MRI Distortion testing was performed according to ASTM F2119-07. RF Heating tests were conducted in accordance with ASTM F2182-09. Testing of magnetically induced displacement force or torque deflection angle was measured to be 5° or less in the 3.0T MRI System in tests performed in accordance with ASTM F2052-06e1. MRI testing of the Vanguard Knee System components determined that the Vanguard System components are MR Conditional within the definition found in ASTM F2503-08.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
15093293
Image /page/0/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in large, bold, block letters with a registered trademark symbol. Below that, in a smaller font, is the text "MANUFACTURING CORP."
OCT 2 2 2010
510(k) Summary
October 20, 2010 Preparation Date:
Biomet Manufacturing Corp. Applicant/Sponsor:
Contact Person: Gary Baker
Proprietary Name: VanguardTM 360 Revision Knee System
Knee prostheses Common Name:
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis (21 CFR §888.3560)
JWH. MBV Product Codes:
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| Vanguard™ SSK Knee System | K042757 | Biomet |
|---|---|---|
| Offset Tibial Tray | K010212 | Biomet |
| MCK [Maxim®] Knee System | K915132 | Biomet |
Device Description: The Vanguard™ 360 Revision Knee System is a series of femoral, tibial and offset adapter components designed to work in conjunction with femoral stems, bearings, trays, augments and patella components of Biomet's previously cleared Maxim® and Vanguard™ SSK knee systems. These components can be used for either primary or revision procedures, but are specifically designed for use where there is inadequate bone stock. Biomet has developed this system in order to expand its product Inacequate oone its currently marketed Vanguard™ [SSK] Knee System (K042757).
The Vanguard™ 360 femoral components are made of Co-Cr-Mo alloy and incorporate the valigation features as the predicate Vanguard SSK femoral components. The tibial components incorporate the same tibial tray profile as the current Biomet Tibial Trays and the predicate Offset Tibial Tray design and are made of Ti-6A1-4V titanium alloy. The femoral and tibial components are designed for use with the Biomet knee stems cleared in the predicate MCK (Maxim ) System. A series of tibial and femoral augments made of Ti-6A1-4V titanium alloy, allow for the modularity to accommodate bone defects that may be present during revision surgeries. The Ti-6Al-4V titanium alloy Offset that may be present adminis system, allow the surgeon to offset the centerline between the
Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.287.6639
Main Fax: 574.267.8137
www.biomet.com
Shipping Address:
56 East Bell Drive
Warsaw, IN 46582
p. lot 2
1
stem and the femoral or tibial components throughout 360 degrees in the transverse axis. Titanium allov Ti-6A1-4V bone screws can be used if additional screw fixation is warranted.
KO93293
Intended Use: Cemented knee replacement device
Indications for Use:
The indications for the Vanguard™ 360 Revision Knee System are as follows:
-
- Painful and disabled knee joint resulting from osteoarthritis, theumatoid 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.
These devices are single-use implants intended for cemented use only.
Summary of Technologies: The technological characteristics (material, design and sizing) of the Vanguard™ 360 Revision Knee System are similar or identical to the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. Based on the information provided below, there are no new issues relating to safety or effectiveness introduced.
- An Engineering Justification demonstrates that the cylindrical Boss geometry is capable 1. of resisting in-vivo torque.
-
- An Engineering Justification addressed the removal of the alignment tab from the femoral Boss
-
- Verification testing of 80/20 Fatigue Strength demonstrated that all components passed testing.
- Verification testing of Cantilever Beam Fatigue demonstrated that all components 4. passed testing.
- 5 MRI Distortion testing was performed according to ASTM F2119-07. RF Heating tests were conducted in accordance with ASTM F2182-09. Testing of magnetically induced displacement force or torque deflection angle was measured to be 5° or less in the 3.0T MRI System in tests performed in accordance with ASTM F2052-06e1. MRI testing of the Vanguard Knee System components determined that the Vanguard System components are MR Conditional within the definition found in ASTM F2503-08.
All trademarks are property of Biomet.
p. 2fz
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Inc. % Mr. Gary Baker Regulatory Affairs Project Manager 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581
OCT 2 2 2010
Re: K093293
Trade/Device Name: Vanguard™ 360 Revision 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, MBV Dated: October 18, 2010 Received: October 19. 2010
|
|
Dear Mr. Baker:
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. Iisting 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 801); medical device reporting (reporting of medical
3
Page 2 - Mr. Gary Baker
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
Sincerely, yours,
Barbara Buchud
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K093293
OCT 2 2 2010
Device Name: Vanguard™ 360 Revision Knee System
The indications for the Vanguard™ 360 Revision Knee System are as follows:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or coulding from oscoarthritis, medit
-
- Correction of varus, valgus, or posttraumatic deformity;
- Correction or revision of each as a successful osteomity,
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total 3. joint replacement procedure.
These devices are single-use implants intended for cemented use only.
Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pelo mo Oci
Page 1 of 1
(Division Sign Oro Division of St rical, Orthopedic, and Restorative Devices
510(k) Number 10693293