(209 days)
The indications for the Patient-Specific Vanguard™ Femoral Components are as follows:
- l . 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. 2.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
These devices are single-use implants intended for cemented applications.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The Patient-Specific Vanguard™ Femoral Components are comprised of a series of CoCrMo femoral components with each size offering an envelope of acceptable dimensions to allow for a fit that is specific to each patient, while still maintaining the Vanguard" design. These components are intended for primary knee arthroplasty.
This document is a 510(k) premarket notification for a medical device called "Patient-Specific Vanguard™ Femoral Components." It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria.
Specifically:
- No acceptance criteria or device performance table: The document does not provide a table outlining specific acceptance criteria (e.g., performance metrics, thresholds) for the device.
- No study proving acceptance criteria are met: The document explicitly states under "Clinical Testing" that "None provided as a basis for substantial equivalence." Non-clinical testing was performed, and the results indicated the device is "functional within its intended use," but this is a general statement and not a detailed study proving specific acceptance criteria are met.
- No information on test set sample size, data provenance, ground truth establishment, or adjudication method: Since no clinical study or formal test set evaluation is presented in the document, these details are not available.
- No MRMC comparative effectiveness study: The document does not describe any study involving human readers and AI assistance.
- No standalone (algorithm only) performance study: The device is a physical femoral component, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
- Type of ground truth: Not applicable as no clinical study or performance evaluation with ground truth is described.
- Training set sample size: Not applicable as this is a physical device, not an AI/algorithm-based product requiring a training set in the conventional sense.
- How ground truth for training set was established: Not applicable for the same reason mentioned above.
In summary, this document is a regulatory submission for a physical medical device and does not contain the type of information requested regarding acceptance criteria and performance studies typically associated with AI/algorithmic medical devices.
{0}------------------------------------------------
K10 2125
p1/2
Image /page/0/Picture/1 description: The image shows the logo for "BOMET MANUFACTURING CORP.". The word "BOMET" is in a stylized font with a geometric design. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.
FEB 2 3 2011
510(k) Summary
Preparation Date: 27 July, 2010
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Gary Baker
Patient-Specific Vanguard™ Femoral Components Proprietary Name:
Common Name: Femoral components
Classification Name: Knee joint patellofemorotibial metal/polymer/metal/polymer semiconstrained cemented prosthesis (21 CFR §888.3560)
Product Code: JWH
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Maxim® Accel Knec System Interlok® Femoral Components – K023546 Biomet
Device Description:
… ;
The Patient-Specific Vanguard™ Femoral Components are comprised of a series of CoCrMo femoral components with each size offering an envelope of acceptable dimensions to allow for a fit that is specific to each patient, while still maintaining the Vanguard" design. These components are intended for primary knee arthroplasty.
Intended Use: Cemented
Indications for Use:
The indications for the Patient-Specific Vanguard™ Femoral Components are as follows:
- l . 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. 2.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
These devices are single-use implants intended for cemented applications.
Mailing Address: P.O. Box 587 Warsaw IN 46581-0587 Toll Free: 300 348 9500 Offica: 574.267.5639 illain Fax 574 257 3137 under bie met com
Shipping Address: 60 East Bell Drive Warsaw IN 48532
{1}------------------------------------------------
K102/25
p2/2
Summary of Technologies: The technological characteristics (material, design and sizing) of the Patient-Specific Vanguard™ Femoral Components are similar or identical to the predicate devices.
Non-Clinical Testing: Non-clinical verification was performed to determine substantial equivalence. The results indicated that the device is functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc., unless otherwise noted.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement on the left side of the image. To the right of the text is a symbol that features three stylized lines that resemble a human figure. The lines are angled upwards and to the right, creating a sense of movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Biomet, Inc. % Mr. Gary Baker, MS, RAC 65 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
FEB 2 3 2011
Re: K102125
Trade/Device Name: Patient-Specific Vanguard™ Femoral Components 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 Dated: February 9, 2011 Received: February 10, 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. 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.
{3}------------------------------------------------
Page 2 - Mr. Garv Baker, MS. RAC
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 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/ReportalProblem/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,
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):_K102125
Device Name: Patient-Specific Vanguard™ Femoral Components
The indications for the Patient-Specific Vanguard™ Femurs are as follows:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis 1. 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.
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)
for M. Melkerm
Page 1 of 1
(Division Sign-Oft) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
§ 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.