(28 days)
Not Found
No
The summary describes a mechanical implant (patella component) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the replacement of part of the knee joint to address painful and disabled knee joints, deformities, and failures of previous joint replacement procedures, which are therapeutic interventions.
No
The device is a knee joint replacement component, not a diagnostic tool. Its intended uses involve direct replacement and correction of knee joint issues, not detection or diagnosis.
No
The device description clearly outlines physical components made of ArCom polyethylene, such as a dome shape, grooves, pegs, and an optional x-ray wire, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical replacement of a part of the knee joint. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical characteristics of a prosthetic implant (shape, material, pegs, etc.). This is consistent with a medical device used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Vanguard™ Patella is a surgical implant used to treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
The Vanguard™ Patella is intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
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- Correction of varus, valqus or posttraumatic deformity.
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- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
Features of the Vanguard™ Patella Components are as follows:
- 1", true dome shape .
- Grooves on the under surface ●
- Single or 3-peg design
- Available with or without an x-ray wire .
- ArCom polvethvlene .
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: Engineering analysis demonstrated equivalence between the Vanguard™ Patella Components and the predicate devices.
Clinical Testing: None provided
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
APR 2 2 2004
Image /page/0/Picture/1 description: The image shows two lines of text. The first line appears to contain the numbers "1.11", with the last "1" being slightly separated from the others. The second line contains the alphanumeric string "K040770", with each character clearly distinguishable.
Image /page/0/Picture/2 description: The image shows the word "BIOMET" in large, bold, black letters. Below the word "BIOMET" is the phrase "510(k) Summary" in a smaller font size. The text is black and the background is white.
Applicant/Sponsor:Biomet Manufacturing Corp.
Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist
Proprietary Name: Vanguard™ Patella Components
Common Name: Patellar Component
Classification Name: Knee joint patellofemorotibial, cemented, polymer/metal/ polymer, semi-constrained
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: AGC® LP Patellar Button - K912245 and K921182
Device Description: Features of the Vanguard™ Patella Components are as follows:
- 1", true dome shape .
- Grooves on the under surface ●
- Single or 3-peg design �
- Available with or without an x-ray wire .
- ArCom polvethvlene .
Intended Use: The intended use of the Vanguard™ Patella Components is replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:
-
- 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.
Summary of Technologies: The overall design, materials and processing of the Vanguard™ Patella Components are similar to the predicate device.
Non-Clinical Testing: Engineering analysis demonstrated equivalence between the Vanguard™ Patella Components and the predicate devices.
Clinical Testing: None provided
All trademarks are property of Biomet, Inc. MALING ADDRESS PO. BOX 587 Warsaw, IN 46581-0587
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Image /page/0/Picture/25 description: The image shows the word "FAX" in bold, followed by the number "52" in a larger, bolder font. The number appears to be part of a phone or fax number. The rest of the number is not clear.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, represented by flowing lines, suggesting unity and collaboration.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2004
Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K040770
Trade/Device Name: Vanguard™ Patella Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint, patellofemorotibial, polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: March 24, 2004 Received: March 25, 2004
Dear Ms. Beres:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revious and have determined the device is substantially equivalent (for the indications forcroneed a o o and in sure) to legally marketed predicate devices marketed in interstate for associated in the 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. ate nos that have boom that do not require approval of a premarket approval application (PMA). and Cosmeter Prov, 100 (110) 1107 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 may or dayset to de 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 or any I 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your your finding of substantial equivalence of your device to a legally prematicated predicated. The 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 If you attire of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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f I
Indications for Use
510(k) Number (if known):
Device Name: Vanguard™ Patella Components
Indications For Use:
The Vanguard™ Patella is intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
-
- Correction of varus, valqus or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_K640770