(114 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 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) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex and OsseoTi components are intended only for uncemented biologic fixation application.
The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral components. The Vanguard DA 360 components are not approved for sale in the United States.
The Vanguard 360 OsseoTi Tibial Sleeve Augments are porous, modular augment sleeves that have been designed to address a wide range of defects in cases of severe bone loss in both primary and revision cases. The subject augments are constructed from a previously cleared materials/additive manufacturing process known as OsseoTi. The OsseoTi process results in a fully integrated part with solid and porous regions. This structure leads to a highly interconnected volume of porosity and promotes biological fixation.
The subject OsseoTi Tibial Sleeve Augments mount directly onto the previously cleared Vanguard 360 Tibial Tray boss via Morse tapers. The subject augments are available in half and full sleeve configurations and multiple sizes.
The medical device in question is the Vanguard® 360 OsseoTi™ Tibial Sleeve Augments.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Construct Testing | Static Axial (Pull Off) Force | Met established criteria | Met or exceeded criteria |
| Torque Resistance | Met established criteria | Met or exceeded criteria | |
| Fatigue | Met established criteria | Met or exceeded criteria | |
| Fretting | Met established criteria | Met or exceeded criteria | |
| MRI Compatibility Justification | Met established criteria | Met or exceeded criteria | |
| OsseoTi Material Characterization | Interconnecting Porosity | Met established criteria | Met or exceeded criteria |
| Micrographs | Met established criteria | Met or exceeded criteria | |
| Porosity and Pore Size | Met established criteria | Met or exceeded criteria | |
| Roughness | Met established criteria | Met or exceeded criteria | |
| Abrasion Resistance | Met established criteria | Met or exceeded criteria | |
| Mechanical Strength | Met established criteria | Met or exceeded criteria | |
| Chemical Composition | Met established criteria | Met or exceeded criteria | |
| Shear Fatigue | Met established criteria | Met or exceeded criteria | |
| Static Shear | Met established criteria | Met or exceeded criteria | |
| Static Tensile | Met established criteria | Met or exceeded criteria | |
| Animal Data | (Not explicitly named, but conducted) | Met established criteria | Met or exceeded criteria |
Note: The document states "All testing met or exceeded the established acceptance criteria," but does not explicitly list the quantitative values of these criteria. The implicit acceptance criteria for each test are that the device performed within the intended use and did not raise new safety or efficacy issues, aligning with the performance of predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical tests (material characterization and construct testing) and "animal data." It explicitly states:
- Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
Therefore, there is no human clinical test set for this submission. The tests performed were laboratory-based and animal studies. The sample sizes for these tests are not specified in the document.
- Data Provenance: The tests are described as non-clinical (laboratory-based material and mechanical testing) and animal data. No country of origin is specified for these studies, nor is it explicitly stated if they were retrospective or prospective, though non-clinical and animal studies are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As there was no human clinical test set for a performance evaluation, the concept of "ground truth" derived from expert consensus on patient data (e.g., radiology reports) is not applicable here. The "ground truth" for the non-clinical tests would be defined by engineering specifications, material science standards, and established biomechanical testing protocols. The qualifications of the engineers/scientists conducting these tests are not provided.
4. Adjudication Method for the Test Set
Not applicable, as there was no human clinical test set requiring adjudication of findings (e.g., medical image interpretations).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Data/Information: None provided as a basis for substantial equivalence." This submission relies on non-clinical and animal data to establish substantial equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the device described. The device is a physical knee implant component, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the non-clinical testing and animal data, the "ground truth" would be established by:
- Engineering specifications and standards: For mechanical properties, fatigue, fretting, static axial force, torque resistance.
- Material science standards: For interconnecting porosity, micrographs, porosity and pore size, roughness, abrasion resistance, mechanical strength, chemical composition, shear fatigue, static shear, static tensile.
- Animal study endpoints: For biocompatibility, bone ingrowth, or other relevant biological responses (details not provided).
There was no "expert consensus," "pathology," or "outcomes data" from human subjects used to establish ground truth for this 510(k) submission.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no training set for a physical medical implant.
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Image /page/0/Picture/2 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 text is black and the background is white. The logo is simple and professional.
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0857 |
| EstablishmentRegistration Number | 1825034 |
| Name of contact person | Jason HeckamanRegulatory Affairs Project Manager |
| Phone number | (574) 371-3707 |
| Fax number | (574) 372-1683 |
| Date prepared | July 30, 2014 |
| Name of device | |
| Trade or proprietaryname | Vanguard® 360 OsseoTi™ Tibial Sleeve Augments |
| Common or usualname | Knee Prosthesis |
| Classification name | Knee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis (21CFR §888.3565) |
| Classification panel | Orthopedic |
| Regulation | 21 CFR §888.3565 |
| Product Code(s) | MBH, JWH |
| Legally marketed device(s)to which equivalence isclaimed | K093293 Vanguard 360 Revision Knee SystemK121149 Vanguard SSK 360 Revision Knee SystemK072336 Regenerex Porous Titanium Sleeve AugmentsK102896 Zimmer Trabecular Metal Tibial Cone Augments |
| Reason for 510(k)submission | The Vanguard 360 OsseoTi Tibial Sleeve Augments are newproducts that are an addition to the Biomet® Vanguard® 360Knee Joint System (K093293 and K121149). |
| Device description | The Vanguard 360 OsseoTi Tibial Sleeve Augments are porous,modular augment sleeves that have been designed to address awide range of defects in cases of severe bone loss in bothprimary and revision cases. The subject augments areconstructed from a previously cleared materials/additivemanufacturing process known as OsseoTi. The OsseoTi processresults in a fully integrated part with solid and porous regions.This structure leads to a highly interconnected volume of porosityand promotes biological fixation. |
| The subject OsseoTi Tibial Sleeve Augments mount directly ontothe previously cleared Vanguard 360 Tibial Tray boss via Morsetapers. The subject augments are available in half and full sleeveconfigurations and multiple sizes. | |
| Intended use of the device | The Vanguard 360 OsseoTi Revision Sleeve Tibial Augments areoptional components intended to be used with the previouslycleared Vanguard 360 Revision Knee System as part of a totalknee construct. The subject augments are intended foruncemented biologic fixation. |
| Indications for use | 1. Painful and disabled knee joint resulting from osteoarthritis,rheumatoid arthritis, traumatic arthritis where one or morecompartments are involved.2. Correction of varus, valgus, or posttraumatic deformity.3. Correction or revision of unsuccessful osteotomy, arthrodesis,or failure of previous joint replacement procedure.The Regenerex femoral augments are indicated for use with theVanguard Total Knee System. |
| The Regenerex tibial augments are indicated for use withstandard and offset Biomet® Tibial Trays. | |
| Femoral components and tibial tray components with porouscoatings are indicated for cemented and uncemented biologicalfixation application. Non-coated (Interlok) femoral components,tibial tray components and all polyethylene patellar componentsare indicated for cemented application only. Regenerex andOsseoTi components are intended only for uncemented biologicfixation application. | |
| The Vanguard DA 360 components are not intended for use withthe Vanguard PS Open Box Porous Femoral components. TheVanguard DA 360 components are not approved for salein the United States.Summary of the technological characteristics of the device compared to the predicate |
P.O. Bax 557 V/201908 RV 4/5501-0567
Total Froor 800-340-9500 Offer 57-1 267 1633 Meto Fex: 574 267 5137 1. 2017
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Image /page/1/Picture/1 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 bold and sans-serif, and the letters are all capitalized. The logo is black and white.
The technological characteristics of the Vanguard 360 OsseoTi Augments are similar to those of predicate systems (K093293/K121149, K072336, K102896) in terms of geometry, design and principle of operation. The subject OsseoTi augments use the same Morse taper for attachment to the previously cleared Vanquard 360 tibial boss as the predicate Vanguard 360 Cruciate Wing augments but with varying taper engagement. The cone shape and sizing of the subject device is similar to the previously cleared Regenerex (K072336) and Zimmer Trabecular Metal Tibial Cone
PO. Box 557 are, in 46681-0587 Tot Free: 200 348 952 - 534 287 6532
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TURING CORP. MANUFA
Augments (K102896). The subject OsseoTi augments are constructed from a previously cleared material/manufacturing process.
CE DE LEGION CONTROLLER PERFORMANCE DATA CONTACT CONTROLLER CONTROLLER CONTROLLER
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
OsseoTi material characterization tests and construct testing used in support of the substantial equivalence included the following:
Construct testing / justifications:
- Static Axial (Pull Off) Force .
- Torque Resistance .
- Fatique ●
- Fretting .
- MRI Compatibility Justification
OsseoTi characterization:
- Interconnecting Porosity ●
- Micrographs
- Porosity and Pore Size
- Roughness
- Abrasion Resistance
- Mechanical Strength
- Chemical Composition
- Shear Fatique
- Static Shear
- Static Tensile
Animal Data
All testing met or exceeded the established acceptance criteria.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The culmination of the results of the mechanical construct testing, OsseoTi characterization and animal data indicated the devices performed within the intended use, did not raise any new safety and efficacy issues, and are substantially equivalent to the predicate devices.
P.O. Box 557
Warm, IN 46581-6587
Toll Free: 800.348.5500
Office: 574 287.5533
Mech Fax: 574.267.8137
www.boxoft.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2014
Biomet, Incorporated Mr. Jason Heckaman Regulatory Affairs Project Manager 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0857
Re: K140883
Trade/Device Name: Vanguard® 360 OsseoTi™ Tibial Sleeve Augments 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: July 1, 2014 Received: July 2, 2014
Dear Mr. Heckaman:
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 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
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Page 2 - Mr. Jason Heckaman
(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 (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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K140883 510(k) Number (if known):
Device Name: - Vanguard® 360 Osseo™ Ti Tibial Sleeve Augments
-
- 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 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) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex and OsseoTi components are intended only for uncemented biologic fixation application.
The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral components. The Vanguard DA 360 components are not approved for sale in the United States.
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)
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Page 1 of 1
Division of Orthopedic Devices
§ 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.