(89 days)
Not Found
No
The document describes a traditional knee replacement system with no mention of AI or ML in its design, function, or intended use.
Yes
This device is a therapeutic device because its intended use is to replace a damaged knee joint, thereby treating conditions like osteoarthritis and rheumatoid arthritis, and correcting deformities.
No
This device is a surgically implanted prosthesis for the knee joint, designed to replace damaged joint components, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components (femoral components, tibial tray components, patellae) made of materials like porous coatings and polyethylene, indicating it is a hardware medical device.
Based on the provided information, 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: The description clearly states that this device is a two-piece system intended for use with additional tibial products to replace the patellofemorotibial joint space. This is a surgical implant, not a device used for testing biological samples.
- Intended Use: The intended uses listed are all related to surgically replacing or correcting issues with the knee joint due to conditions like osteoarthritis, rheumatoid arthritis, or previous surgical failures. These are clinical indications for surgical intervention, not diagnostic testing.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
The Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove product line is a two piece system intended for use with additional tibial products to replace the patellofemorotibial joint space. The system is composed of one type of femoral and two types of patellae. The system can be used with any commercially available Biomet® Tibial Tray, Vanguard™ CR, CR-L, or AS bearing, or augment.
The femoral component is cruciate retaining (CR) in both left and right configurations. The femoral implants are available in both Interlok® and porous finish. The sizes of femoral implants range from: 55 - 80mm.
Two different all-polyethylene patellae designs will function with the new femoral components a round, modified dome and a medially offset patella. Both designs have 3-pegs, concentric grooves, and cement pockets for cement fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint patellofemorotibial
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.
K023546, K033489, K040770, K921182, K041160, K020841, K051948, K872379, K874547, K972270, K032163
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
Image /page/0/Picture/0 description: The image shows the logo for Biomet Orthopedics Inc. The logo is a stylized version of the word "BIOMET" in bold, block letters. Above the logo, there is handwritten text that reads "K061433 (pg 1 of 2)".
AUG 2 1 2006
510(k) Summary
Preparation Date: May 23, 2006
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Tracy Bickel Johnson, RAC
Proprietary Name: Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove
Common Name: femoral and patella components
Classification Name(s):
- Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (888.3560)
- · Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (888.3565)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Vanguard™ (Maxim® Accel) -K023546 and K033489 (Biomet, Inc.), Vanguard™ Patella- K040770 (Biomet, Inc.), UHMWPE Components- K921182 (Biomet, Inc.), Avon™ PFJ Prosthesis ~ K041160, K020841, and K051948 (Stryker/Howmedica/Osteonics), Insall/Burstein® II – K872379 (Biomet, Inc.), Performance® Knee System -K874547 (Biomet, Inc.), NexGen® All-Poly Patella – K972270 (Zimmer Holdings), Duracon® CR – K032163 (Stryker/Howmedica/Osteonics)
Device Description:
The Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove product line is a two piece system intended for use with additional tibial products to replace the patellofemorotibial joint space. The system is composed of one type of femoral and two types of patellae. The system can be used with any commercially available Biomet® Tibial Tray, Vanguard™ CR, CR-L, or AS bearing, or augment.
The femoral component is cruciate retaining (CR) in both left and right configurations. The femoral implants are available in both Interlok® and porous finish. The sizes of femoral implants range from: 55 - 80mm.
Two different all-polyethylene patellae designs will function with the new femoral components a round, modified dome and a medially offset patella. Both designs have 3-pegs, concentric grooves, and cement pockets for cement fixation.
MAILING ADDRESS 120. Box 587 Warsaw, IN 46581-0587
SHIPPING ADDRESS 56 E. Bell Drive Warsaw. IN 46582
OFFICE 574.267.6639
574.25.137
I:-MAIL biomet@biome1.com
1
K061433 (pg 2 of 2)
510(k) Summary Vanguard™ (APG) / Vanguard™ V Groove Page 2 of 2
Intended 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.
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 technological characteristics (material, design, sizing, indications) of the Vanguard™ APG are similar to or identical to the predicate devices.
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 belong to Biomet, Inc. except the following:
Avon is a trademark of Stryker/Howmedica/Osteonics Insall Burstein II is a trademark of Zimmer Holdings NexGen is a trademark of Zimmer Holdings Duracon CR is a trademark of Stryker/Howmedica/Osteonics
5 - 2
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus-like symbol with three abstract human figures connected by flowing lines, representing health and well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" encircles the symbol, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2006
Biomet Manufacturing Corp. % Tracy Bickel Johnson, RAC Manager, Regulatory Affairs 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K061433
Trade/Device Name: Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove Regulation Number: 21 CFR 888.3565
Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented
prosthesis Regulatory Class: Class II Product Codes: MBH, JWH Dated: May 23, 2006 Received: May 24, 2006
Dear Ms. Johnson:
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 - Ms. Tracy Bickel Johnson );
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 Office of Compliance at (240) 276-0120. 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 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,
Barbara Brien
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_KO6/ 433
Device Name: Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove
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.
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.
Prescription Use メ (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)
Lubara Buchard franken
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K061433
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