(52 days)
Not Found
No
The summary describes a knee implant made of titanium, focusing on material differences for patients with metal sensitivity. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a knee implant designed to replace a painful or disabled knee joint, which is a structural repair rather than a direct therapeutic intervention.
No
The device is a knee implant designed to replace a painful and disabled knee joint, not to diagnose a condition.
No
The device description clearly states it is a "Knee System Titanium Femoral Components," which are physical implants, not software.
Based on the provided information, 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 damaged knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a femoral component for a knee replacement system, made of titanium. This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a medical device (specifically, a surgical implant), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved.
- Failure of previous joint replacement procedure.
- Correction of varus/valgus or post-traumatic deformity.
- Correction or revision of unsuccessful osteotomy, or arthrodesis.
- Device designed for use in patients with metal sensitivity.
- Standard surgical and rehabilitative procedures are indicated with this device.
- The device is a single-use device intended for use with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Vanguard™ Knee System Titanium Femoral Components have the same design as the predicate Vanguard™ femoral knee components originally cleared as the Maxim® Accel Knee System femoral components. The difference in material offers the opportunity for total knee replacement to those patients with metal sensitivity to the nickel element of the predicate Co-Cr-Mo Cobalt - Chromium alloy femoral knee components.
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. The results indicated that the device was functional within its intended use.
Clinical Testing: 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.
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
K080204 (pg 1/2)
Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with the letters connected. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.
MAR 2 0 2008
510(k) Summary
| Preparation Date: | 23 January, 2008 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corporation |
| Contact Person: | Gary Baker, MS RAC |
| Proprietary Name: | Vanguard TM Knee System Titanium Femoral Components |
| Common Name: | Titanium femoral knee components |
| Classification Name: | Knee joint, patellofemorotibial polymer/metal/polymer semi- constrained cemented prosthesis (21 CFR § 888.3560) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Biomet Titanium Femoral Component -- K981996 (Biomet Inc.) Maxim Accel Knee System - K023546 (Biomet Inc.) Vanguard " SSK Knee System - K042757 (Biomet Inc.)
Device Description: The Vanguard™ Knee System Titanium Femoral Components have the same design as the predicate Vanguard™ femoral knee components originally cleared as the Maxim® Accel Knee System femoral components. The difference in material offers the opportunity for total knee replacement to those patients with metal sensitivity to the nickel element of the predicate Co-Cr-Mo Cobalt - Chromium alloy femoral knee components.
Indications for Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved.
-
- Failure of previous joint replacement procedure.
-
- Correction of varus/valgus or post-traumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, or arthrodesis.
- · Device designed for use in patients with metal sensitivity.
- · Standard surgical and rehabilitative procedures are indicated with this device.
- · The device is a single-use device intended for use with bone cement.
Summary of Technologies: The Vanguard™ Knee System Titanium Femoral Components have the same indications for use and the same design technology as the predicate devices.
Mailing Address P.O. Box 587 Warsaw. IN 46581-058 Toll Free: 800-348-9500 Office: 574.267.6639 ain Fax: 574.267.8137 www.biomet.com
Shipping Address 66 East Bell Drive Varsaw IN 46587
Section 5 - Page 1
1
KOBOZOY (pg 2/2)
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet, Inc. % Mr. Gary Baker 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581
MAR 2 0 2008
Re: K080204 Trade/Device Name: Vanguard™ Knee System Titanium Femoral Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prothesis Regulatory Class: II Product Code: JWH Dated: January 23, 2008 Received: January 28, 2008
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 such 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); 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.
3
Page 2 - Mr. Gary Baker
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Mark N. Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO80204 (pg 1/1)
SECTION 4 - INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Page 1 of 1
Device Name: Vanguard™ Knee System Titanium Femoral Components
Indications for Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved.
-
- Failure of previous joint replacement procedure.
-
- Correction of varus/valgus or post-traumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, or arthrodesis.
- . Device designed for use in patients with metal sensitivity.
- Standard surgical and rehabilitative procedures are indicated with this device. .
- . The device is a single-use device intended for use with bone cement.
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)
Souther
(Division Sign-Off)
ช้ Division of General, Restorative, and Neurological Devices
510(k) Number K080204