(29 days)
No
The summary describes a mechanical implant (stem housing) and its intended use, materials, and sizes. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven decision-making process. The performance studies are non-clinical laboratory tests, not studies involving AI/ML performance metrics.
Yes
The device is a knee implant intended to correct painful and disabled knee joints resulting from various arthritic conditions or previous unsuccessful surgical procedures, which constitutes a therapeutic purpose.
No
The device description indicates it is an implant (Vanguard™ CR Stem Housings) used to enhance fixation of a prosthesis to bone, specifically for knee joint replacement procedures. It treats conditions rather than diagnosing them.
No
The device description explicitly states that the device is comprised of Co-Cr-Mo and is a single-use implant, indicating it is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a knee joint component) used to replace or correct issues within the knee joint itself. It is implanted directly into the body.
- Lack of IVD Characteristics: There is no mention of testing bodily samples, analyzing biological markers, or providing diagnostic information based on laboratory analysis.
This device is a surgical implant used for orthopedic procedures, not an IVD.
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 joint replacement procedure.
Vanguard™ CR Stem Housings are indicated for use with Vanguard™ CR Femorals. The devices are single-use implants intended for cemented applications.
Product codes
JWH
Device Description
The Vanguard™ CR Stem Housings are comprised of Co-Cr-Mo and enhance fixation of prosthesis to bone. The device is to be used with the appropriate Vanguard™ knee components and is available in 10 sizes.
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: Non-clinical laboratory testing 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.
Key Metrics
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
OCT 2 4 2008
Image /page/0/Picture/2 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a bold, sans-serif font, with a registered trademark symbol in the upper right corner. Below the logo, the words "MANUFACTURING CORP." are printed in a smaller, sans-serif font.
510(k) Summary
- September 24, 2008 Preparation Date:
Biomet Manufacturing Corp. Applicant/Sponsor:
Contact Person: Susan Alexander
Vanquard™ CR Stem Housings Proprietary Name:
Knee prosthesis Common Name:
Classification Name/Product Code:
21 CER 6888.3560, Knee Joint Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH)
Legally Marketed Devices to Which Substantial Equivalence Is Claimed:
Maxim® CR Revision Stems (Cement-On Femoral Stems), K963709, Biomet, Inc.
Device Description:
Device Description:
The Vanguard™ CR Stem Housings are comprised of Co-Cr-Mo and enhance fixation of prosthesis to bone. The device is to be used with the appropriate Vanguard™ knee components and is available in 10 sizes.
Indications for Use:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis 1. where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity. 2.
- Correction or railab, raigessful osteotomy, arthrodesis, or failure of previous joint replacement 3. procedure.
Vanguard™ CR Stem Housings are indicated for use with Vanguard™ CR Femorals. The devices are single-use implants intended for cemented applications.
Summary of Technologies:
Stimmal your real characteristics (material, design and sizing) of the Vanguard™ CR Stem Housings are similar or identical to the predicate device.
Non-Clinical Testing:
Non-clinical laboratory testing 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
Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800,348.9500 Office: 574.267.6639 Main Fax: 574 267 8137 ww.biomet.com
Shipping Address: 56 East Bell Drive Warsaw, IN 46582
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wing-like shapes, representing the department's mission to protect the health of all Americans. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corporation % Ms. Susan Alexander Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K082826
Trade/Device Name: Vanguard™ CR Stem Housings Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: September 24, 2008 Received: September 25, 2008
OCT 2 4 2008
Dear Ms. Alexander:
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.
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Page 2 - Ms. Susan Alexander
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): _ KO82826
Device Name: Vanquard™ CR Stem Housings
Indications for Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, traumatoid 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.
Vanguard™ CR Stem Housings are indicated for use with Vanguard™ CR Femorals. The devices are single-use implants intended for cemented applications.
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)
Mark A. Mellman
Page 1 of 1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number