(30 days)
- 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.
The Regenerex™ femoral augments are indicated for use with the Vanguard" Total Knee System.
The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.
Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (InterlokTM) devices and all-polyethylene patellar components are indicated for cemented application only. Regenerex™ components are intended only for uncemented biologic fixation application.
The Biomet® Splined Knee Stems V2 are intended for cemented fixation to provide additional stability to femoral or tibial knee components where needed.
This submission describes modifications to compatible components of the Vanguard SSK 360 Revision Knee System. Specifically, the design and size offering was modified.
The provided text describes a 510(k) premarket notification for a medical device (Vanguard® SSK 360 Revision Knee System), focusing on modifications to compatible components, specifically the "Biomet® Splined Knee Stems V2." The document states that the changes "do not affect the intended use or alter the fundamental scientific technology of the device."
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Acceptable stability of stems after fit analysis | "All stems tested met the acceptance criteria of 'acceptable stability'." |
| No new risks of bone perforation or fracture due to design modifications | "Secondary evaluation determined that the design modifications did not introduce any new risks of bone perforation or fracture." |
| Taper connection not affected by proposed design modifications compared to predicate stems | "An engineering justification evaluated the proposed modifications and demonstrated that the proposed design modifications would not affect the taper connection of the stems as compared to the predicate stems." |
| MR Conditional status maintained within existing parameters | "The modified stems are determined to be MR Conditional within the parameters of the previously tested Vanguard 360 Revision Knee System stems." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Fit Analysis Performance Testing" and "secondary evaluation" but does not specify the sample size of stems or components used for these non-clinical tests.
The data provenance is non-clinical testing, performed by the manufacturer, Biomet Manufacturing Corp. The document does not provide details on the country of origin of the data beyond implicitly being from the manufacturer's testing. It is inherently retrospective in the sense that it's testing a design modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention any human experts used to establish ground truth for the non-clinical testing performed. The "acceptance criteria" appear to be based on engineering and design specifications.
4. Adjudication Method for the Test Set
Since human experts were not involved in establishing the ground truth for this non-clinical testing, no adjudication method was used. The assessment appears to be based on direct measurement and engineering analysis against predefined specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical Data was not required to demonstrate substantial equivalence to the predicate Vanguard® 360 Revision Knee System (K093293)."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is a physical medical device (knee stems), not an AI algorithm. Therefore, the concept of a "standalone (i.e., algorithm only without human-in-the-loop performance)" study does not apply.
7. The Type of Ground Truth Used
The ground truth used for the non-clinical tests appears to be based on engineering specifications and performance metrics for fit, stability, and absence of new risks (e.g., bone perforation, fracture, effect on taper connection) as defined by the manufacturer for the device's intended function. Additionally, the MR Conditional status implies adherence to predefined safety standards for MRI compatibility.
8. The Sample Size for the Training Set
This document describes a non-clinical evaluation of a physical device modification, not an AI algorithm. Therefore, the concept of a "training set" does not apply.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" is not applicable here.
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MAY 1 6 2012
PAGE 1 of 2
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
Preparation Date:
6 April. 2012
Applicant/Sponsor:
Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587
Contact Person:
Gary Baker, MS RAC Senior Regulatory Specialist 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587
Tel: 574-267-6639 Ext .1568 Fax: 574-371-1027 e-mail: gary.baker@biomet.com
Proprietary Name:
Vanguard® SSK 360 Revision Knee System - K093293
Knee joint patellofemorotibial, semi-constrained, cemented
polymer/metal/polymer (21 CFR § 888.3560)
Common Name:
Classification Name(s):
Product Code(s)
JWH
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Vanguard 360 Revision Knee System - K093293
Knee prosthesis
Device Description:
This submission describes modifications to compatible components of the Vanguard SSK 360 Revision Knee System. Specifically, the design and size offering was modified.
Intended Use:
The Biomet® Splined Knee Stems V2 are intended for cemented fixation to provide additional stability to femoral or tibial knee components where needed.
{1}------------------------------------------------
Indications For Use:
Indications for Use:
PAGE 2 of 2
- 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.
The Regenerex™ femoral augments are indicated for use with the Vanguard" Total Knee System.
The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.
Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (InterlokTM) devices and all-polyethylene patellar components are indicated for cemented application only. Regenerex™ components are intended only for uncemented biologic fixation application.
Summary of Technologies:
The Biomet® Splined Knee Stems V2 have the same technological characteristics as the predicate devices except for a slight modifications to the general design as described in this Special 510(k) notification. The changes do not affect the intended use or alter the fundamental scientific technology of the device. A risk analysis was conducted that evaluated the proposed modifications. The risk analysis concluded that the proposed modifications to the splined stems do not introduce any new risks.
Non-Clinical Testing:
Fit Analysis Performance Testing was conducted to determine the fit of the subject stems. All stems tested met the acceptance criteria of "acceptable stability". Secondary evaluation determined that the design modifications did not introduce any new risks of bone perforation or fracture.
An engineering justification evaluated the proposed modifications and demonstrated that the proposed design modifications would not affect the taper connection of the stems as compared to the predicate stems.
The modified stems are determined to be MR Conditional within the parameters of the previously tested Vanguard 360 Revision Knee System stems.
Clinical Testing:
Clinical Data was not required to demonstrate substantial equivalence to the predicate Vanguard® 360 Revision Knee System (K093293).
All trademarks are property of Biomet, Inc.
127
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Image /page/2/Picture/0 description: The image contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in bold and is written in all capital letters. The text is likely part of a document or presentation related to the Department of Health and Human Services.
Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corp. % Mr. Gary Baker, Senior Regulatory Specialist 56 East Bell Drive PO Box 587 Warsaw, IN 46581-0587
MAY 1 6 2012
Re: K121149
Trade/Device Name: Vanguard SSK 360 Revision Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint patellofemorotibial, semi-constrained,
cemented polymer/metal/polymer
Regulatory Class: II Product Code: JWH Dated: April 12, 2012 Received: April 16, 2012
Dear Mr. Baker:
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. Iisting 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 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
{3}------------------------------------------------
Page 2 - Mr. Gary Baker
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. 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/ucm115809.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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Vanguard® SSK 360 Revision Knee System
Indications for Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, theumatoid 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.
The Regenerex"" femoral augments are indicated for use with the Vanguard" Total Knee System.
The Regenerex " tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.
Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok™) devices and allpolyethylene patellar components are indicated for cemented application only. Regenerex™ components are intended only for uncemented biologic fixation application.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. R. Sato
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121149
Page 1 of 1
§ 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.