(52 days)
No
The summary describes a mechanical implant (femoral component) and mentions non-clinical testing like Finite Element Analysis, but there is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is a femoral component used to replace parts of the knee joint in cases of arthritis, deformity, or failed joint replacements, which are all conditions that cause pain and disability. Its purpose is to restore function and alleviate discomfort, classifying it as a therapeutic device.
No
The device is described as an implantable femoral component for knee replacement, which is a therapeutic device, not a diagnostic one. Its indications for use describe conditions that would lead to its implantation for treatment, not for diagnosis.
No
The device description clearly states it is a "single use implant" and describes physical components like "femoral components" and "porous-coated inner surface," indicating it is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating knee joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a femoral component for knee replacement, which is a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Vanguard™ PS Open Box Porous Femoral Components are indicated for cemented or non-cemented use in cases of:
-
- 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.
The device is a single use implant.
Product codes
MBH, JWH
Device Description
The Vanguard™ PS Open Box Porous Femoral Components described in this submission have the same articulating surface as the predicate Maxim® Accel (Vanguard™) posterior stabilized (PS) Interlok® femoral components and the cruciate retaining (CR) porous femoral components cleared in K023546 and feature the exact same porous-coated inner surface as the cruciate retaining (CR) porous design cleared in K023546 and K033489.
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: To supplement previous testing, an engineering justification including a Finite Element Comparison was performed. 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Kobo3o3
Image /page/0/Picture/1 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are all capitalized and connected, forming a single, continuous shape. The word is in black and the background is white.
510(k) Summary
| Preparation Date: | February 2, 2006 | MAR 3 0 2006 |
|---|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. | |
| Contact Person: | Susan Alexander | |
| Proprietary Name: | Vanguard™ PS Open Box Porous Femoral Components | |
| Common Name: | Porous coated knee replacement components |
Classification Name: Cemented semi-constrained polymer knee prosthesis [888.3560]; Crassinceren Namer
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim® Accel Knee System (K023546); Non-Cemented Porous Coated Knees (K033489)
Device Description: The Vanguard™ PS Open Box Porous Femoral Components described in this submission have the same articulating surface as the predicate Maxim® Accel (Vanguard™) posterior stabilized (PS) Interlok® femoral components and the cruciate retaining (CR) porous femoral components cleared in K023546 and feature the exact same porous-coated inner surface as the cruciate retaining (CR) porous design cleared in K023546 and K033489.
Intended Use: The Vanguard™ PS Open Box Porous Femoral Components are indicated for cemented or non-cemented use in cases of:
- t . 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 3. replacement procedure.
The device is a single use implant.
Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the Sunning your Toonnorogram Components are similar to or identical to the predicate devices.
Non-Clinical Testing: To supplement previous testing, an engineering justification including a Finite Element Comparison was performed. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
MAILING ADDRESS 110. Box 587 Warsaw. IN 46581 0587
SHIPPING ADDRESS 56 E. Bell Drive Wars:is. IN 16552
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のFFにIC 574.267.66.39
FAX 574.267.8137
10
II:- MAII. bjonnet @ biomet com
All trademarks are property of Biomet with the exception of the following: Insall/Burstein II(@ is a trademark of Zimmer, Inc. Tyvek® is a trademark of E.I. dePont de Nemours and Company
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a representation of human figures.
MAR 3 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. c/o Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K060303
Trade/Device Name: Vanguard™ PS Open Box Porous Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: February 3, 2006 Received: February 6, 2006
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
2
Page 2 - Ms. Susan Alexander
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hulin Lemon w
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Vanguard™ PS Open Box Porous Femoral Components
Indications For Use:
The Vanguard™ PS Open Box Porous Femoral Components are indicated for cemented or non-cemented use in cases of:
-
- 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.
The device is a single use implant.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use NO (Part 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)
Helent Semenho
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K060303
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