(20 days)
Not Found
No
The summary describes a physical implant (patellar component) made of polyethylene and focuses on its mechanical properties and equivalence to predicate devices. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device is intended for replacement of a painful and disabled knee joint, correction of deformities, or revision of unsuccessful prior procedures, all of which aim to alleviate symptoms and restore function, classifying it as therapeutic.
No
This device is an orthopedic implant (a patellar component for knee replacement), which is a therapeutic device, not a diagnostic one. Its purpose is to replace part of a joint to treat conditions like osteoarthritis or deformities, not to diagnose them.
No
The device description explicitly states the device is machined of polyethylene (UHMWPE), indicating it is a physical implant, 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 states the device is for "replacement of part of the knee joint". This is a surgical implant, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a "Patellar Component" made of polyethylene, which is consistent with a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
The device is a medical device, specifically a prosthetic implant for knee replacement surgery.
N/A
Intended Use / Indications for Use
The Vanguard® Asymmetrical Patella is intended for replacement of part of the knee joint in conjunction with a femoral and tibial component.
-
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 total joint replacement procedure.
Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented 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)
JWH
Device Description
The Vanguard® Patellar Component is machined of polyethylene (UHMWPE) conforming to ASTM F-648.
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)
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
The Vanguard® Asymmetrical Patellar component has the same technological characteristics as the predicate devices except for a slight modification to the general design as described in this 510(k) notification. A risk analysis was conducted along with an engineering rationale to demonstrate equivalence of the subject products to the predicate devices.
Comparative Performance Information Summary
| Characteristic | Requirement | New Device | Predicate Device |
|---|---|---|---|
| Patellofemoral Stability | Meet or exceed parameters | Meet | K921182 |
| Contact Area Analysis | Meet or exceed parameters | Meet | K921182 |
| Peg Shear Area Analysis | Meet or exceed parameters | Meet | K040770 |
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information: N/A
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No clinical testing was necessary for a determination of substantial equivalence.
The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
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.
K040770 Vanguard Patellar Components, K051977 Scorpio X3 UHMWPE Patellar Components
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
FEB 2 8 2011
Image /page/0/Picture/2 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized, blocky font with a small trademark symbol in the upper right corner. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.
21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell Drive |
| Warsaw, IN 46581-0857 | |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| Establishment | |
| Registration Number | 1825034 |
| Name of contact | |
| person | Tamara West |
| Date prepared | February 4, 2011 |
| Name of device | |
| Trade or proprietary | |
| name | Vanguard® Asymmetrical Patellar Component |
| Common or usual | |
| name | Knee Prosthesis |
| Classification name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (21CFR §888.3560) |
| Classification panel | Orthopedic |
| Regulation | 21CFR §888.3560 |
| Product Code(s) | JWH |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | K040770 Vanguard Patellar Components |
| K051977 Scorpio X3 UHMWPE Patellar Components | |
| Reason for 510(k) | |
| submission | Addition of asymmetrical designed patella to the Vanguard® product line |
| Device description | The Vanguard® Patellar Component is machined of polyethylene (UHMWPE) conforming to ASTM F-648. |
| Intended use of the | |
| device | The Vanguard® Asymmetrical Patellar is intended for replacement of part of the knee joint in conjunction with a femoral and tibial component. |
| Indications for use | 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or more compartments are involved. |
- Box 56
p. 1 of 3
1
KII0362
BIOMET®
MANUFACTURING CORP.
- Correction of varus, valqus, or posttraumatic deformity: 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.
Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (Interlok(8) devices and all polyethylene patellar components are indicated for cemented application only.
Summary of the technological characteristics of the device compared to the predicate
| Characteristic | New Device | Predicate |
|---|---|---|
| Design | Asymmetrical or medialized | |
| dome | K051977 & K040770 | |
| Material | UHMWPE | K040770 |
| Principal of operation | Primary replacement of a | |
| total knee joint | K040770 | |
| Dimensions | 25, 28 & 31 x 8 mm | |
| 34 x 8.5 mm | ||
| 37 & 40 x 10 mm | K040770 |
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
The Vanguard® Asymmetrical Patellar component has the same technological characteristics as the predicate devices except for a slight modification to the general design as described in this 510(k) notification. A risk analysis was conducted along with an engineering rationale to demonstrate equivalence of the subject products to the predicate devices.
Comparative Performance Information Summary
| Characteristic | Requirement | New Device | Predicate Device |
|---|---|---|---|
| Patellofemoral | |||
| Stability | Meet or exceed parameters | Meet | K921182 |
| Contact Area | |||
| Analysis | Meet or exceed parameters | Meet | K921182 |
| Peg Shear Area | |||
| Analysis | Meet or exceed parameters | Meet | K040770 |
PO Box 587
Warsaw. IN 46081-0557
Toll Free: 800.348.9500
Oficer 574 257,683
Main F74.2878137
wwww.bmet.an
. 2 of 3
2
Image /page/2/Picture/0 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized font, with the words "MANUFACTURING CORP." printed below. The font is blocky and sans-serif, and the letters are outlined in black.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information: N/A
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No clinical testing was necessary for a determination of substantial equivalence.
The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
PO Box 587
Warsaw, IN 46081-000?
Toll Free: 800 348.9000
Offor: 574 257.6833
Main Fax: 574.287.8137
www.comet.axn
p. 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three wing-like shapes above a wavy base, all rendered in black.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Inc. % Ms. Tamara West Senior Regulatory Affairs Specialist 56 East Bell Drive, POB 587 Warsaw, Indiana 46581-0587
FEB 2 8 201
Re: K110362
Trade/Device Name: Vanguard® Asymmetrical Patellar 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 04, 2011
Received: February 08, 2011
Dear Ms. West:
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.
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
4
Page 2 - Ms. Tamara West
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 (OS) 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/CDRH0ffices/ycm115809.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/ReportaProblem/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,
yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):_ k1/0362
Device Name: Vanguard® Asymmetrical Patella
Indications For Use:
The Vanguard® Asymmetrical Patella is intended for replacement of part of the knee joint in conjunction with a femoral and tibial component.
-
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 total joint replacement procedure.
Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (interlok) devices and all polyethylene patellar components are indicated for cemented application only.
Prescription Use × (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)
M. Melker
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K110362