(90 days)
None
No
The summary describes a mechanical knee replacement system and its components, with no mention of AI or ML technologies in its design, function, or testing.
Yes
The device is a total knee replacement system intended to address painful and disabled knee joints resulting from conditions like osteoarthritis and rheumatoid arthritis, which are therapeutic functions.
No
The device is a total knee replacement system used for surgical intervention, not for diagnosing medical conditions. Its intended use involves correcting deformities and replacing damaged knee joints.
No
The device description clearly outlines physical components made of materials like Co-Cr-Mo and polyethylene, indicating it is a hardware 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 describes the device as a total knee replacement system for treating painful and disabled knee joints due to various conditions and for correcting deformities or revising previous procedures. This is a surgical implant used in vivo (within the body).
- Device Description: The device is described as a system of components (femoral components, tibial bearings, tibial trays, patellar components) made of materials like Co-Cr-Mo and polyethylene. These are physical implants designed to replace parts of the knee joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is clearly an implant used inside the body.
N/A
Intended Use / 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 total joint replacement procedure.
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 consists of femoral components composed of cast Co-Cr-Mo per ASTM F-75 with either a porous plasma spray (PPS) or Interlok® surface finish, tibial bearings molded of polyethylene (UHMWPE) conforming to ASTM F-648 or machined of polyethylene (UHMWPE or UHMWPE with a-tocopherol) conforming to ASTM F-648, tibial trays (not part of this submission) and patellar components machined of polvethylene (UHMWPE) conforming to ASTM F-648.
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
Non-Clinical Testing: Mechanical testing was previously performed to determine substantial equivalence. All testing met or exceeded the established acceptance criteria. The following test reports were provided in the predicate 510(k)s.
Tibial-femoral Contact Area, Patello-femoral Contact Area. Patellofemoral Mechanical Stability, Tibialfemoral Constraint, Tibialfemoral Mechanical Stability, Posterior Stabilized Fatigue, Posterior Stabilized Static Load, Range of Motion Analysis. 80/20 Femoral Fatigue, Vanguard® PS Open Box Tensile Stress, Constraint testing of AS and CR-L, Contact Area Analysis (AS bearing), Static Rotational Strength Test (PS+), Varus/Valgus Constraint (PS+), Tensile Strength E-poly, Wear Testing E-poly, and Contact Areas Analysis (patellar)
Clinical Testing: Clinical data is not necessary for a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K023546, K033489, K041046, K050222, K060303, K061340, K080528
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
FEB 2 9 2012
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Image /page/0/Picture/2 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized font with thick, blocky letters. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The text is black on a white background.
510(k) Summary
| Preparation Date: | 28 November, 2011 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| 56 East Bell Drive | |
| P.O. Box 587 | |
| Warsaw, IN 46581-0857 | |
| Establishment Registration No. 1825034 | |
| Contact Person: | Gary Baker, MS RAC |
| Senior Regulatory Affairs Specialist | |
| Biomet Manufacturing Corp. | |
| 56 East Bell Drive | |
| Warsaw, Indiana 46580 | |
| Phone: (574) 371-6639 | |
| Fax: (574) 371-1027 | |
| gary.baker@biomet.com | |
| Proprietary Name: | Vanguard® Complete Knee System |
| Common Name: | Knee Prosthesis |
| Classification Name: | Knee joint patellofemorotibial metal/polymer porous- coated |
| uncemented prosthesis (21CFR §888.3565) | |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained |
| cemented prosthesis (21CFR §888.3560) | |
| Classification Name: | Knee joint patellofemorotibial polymer+Additive/metal/polymer+Additive |
| semi-constrained cemented prosthesis (21CFR §888.3560) | |
| Legally Marketed Devices To Which Substantial Equivalence Is Claimed: | K023546 Vanguard® CR Knee System |
| K033489 Vanguard® CR Knee System | |
| K041046 Vanguard® PS+ Bearings | |
| K050222 Vanguard® AS Tibial Bearings | |
| K060303 Vanguard® PS Open Box Porous Femoral | |
| K061340 Vanguard® Single Peg Patella | |
| K080528 E1® Tibial Components (previously E-poly) |
1
Device Description: The Vanguard® Complete Knee System is a total knee replacement system for either primary or revision knee arthroplasty. It consists of femoral components composed of cast Co-Cr-Mo per ASTM F-75 with either a porous plasma spray (PPS) or Interlok® surface finish, tibial bearings molded of polyethylene (UHMWPE) conforming to ASTM F-648 or machined of polyethylene (UHMWPE or UHMWPE with a-tocopherol) conforming to ASTM F-648, tibial trays (not part of this submission) and patellar components machined of polvethylene (UHMWPE) conforming to ASTM F-648.
Intended Use: 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.
Summary of Technologies: The Vanguard® Complete Knee System components have the same technological characteristics as the predicate components with the exception of the modifications described within this 510(k). Non-clinical testing was conducted to demonstrate that the modifications did not adversely affect safety and efficacy, and to demonstrate substantial equivalence to the predicate components.
Non-Clinical Testing: Mechanical testing was previously performed to determine substantial equivalence. All testing met or exceeded the established acceptance criteria. The following test reports were provided in the predicate 510(k)s.
Tibial-femoral Contact Area, Patello-femoral Contact Area. Patellofemoral Mechanical Stability, Tibialfemoral Constraint, Tibialfemoral Mechanical Stability, Posterior Stabilized Fatigue, Posterior Stabilized Static Load, Range of Motion Analysis. 80/20 Femoral Fatigue, Vanguard® PS Open Box Tensile Stress, Constraint testing of AS and CR-L, Contact Area Analysis (AS bearing), Static Rotational Strength Test (PS+), Varus/Valgus Constraint (PS+), Tensile Strength E-poly, Wear Testing E-poly, and Contact Areas Analysis (patellar)
Clinical Testing: Clinical data is not necessary for a determination of substantial equivalence.
Conclusion: The Vanguard® Complete Knee System is substantially equivalent to previously cleared Biomet knee systems and do not raise any new issues of safety or efficacy.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a double-stranded snake winding around a staff.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corp. % Mr. Gary Baker, MS RAC Senior Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46580
FEB 2 9 2012
Re: K113550
Trade/Device Name: Vanguard Complete 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, MBH, OIY . Dated: November 28, 2011 Received: December 1, 2011
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Gary Baker
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 yours,
Erina Keith
Image /page/3/Picture/6 description: The image shows a stylized handwritten word, possibly "for". The "f" is written in a cursive style with a long, curved descender. The "o" is connected to the "f" and is also written in a cursive style. The "r" is connected to the "o" and is also written in a cursive style. The word is written in black ink on a white background.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and · Radiological Health
Enclosure
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Indications for Use
KIJSEED 510(k) Number (if known):
Device Name: Vanguard® Complete 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 total joint replacement procedure.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NQ (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)
K
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KII 3 E CO 510(k) Number_