(114 days)
Not Found
No
The document describes a mechanical implant (tibial sleeve augments) and its material properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a modular augment sleeve intended to address bone loss in painful and disabled knee joints resulting from various arthritic conditions and deformities. This directly addresses medical conditions to restore function or alleviate symptoms.
No
This device is a surgical implant (tibial sleeve augments) used for knee replacement procedures, not for diagnosing conditions.
No
The device description clearly states it is a physical implant (porous, modular augment sleeves) made from a specific material (OsseoTi) and designed to address bone loss in knee joints. It is a hardware device.
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 the knee joint to address issues like osteoarthritis, rheumatoid arthritis, traumatic arthritis, deformities, and revisions of previous procedures. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as porous, modular augment sleeves made from a material called OsseoTi, designed to address bone loss in the knee. This is a physical implant.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status through in vitro analysis.
- Performance Studies: The performance studies focus on mechanical testing, material characterization, and animal data, all related to the physical properties and biological fixation of the implant. There are no studies related to diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
The Vanguard 360 OsseoTi Revision Sleeve Tibial Augments are optional components intended to be used with the previously cleared Vanguard 360 Revision Knee System as part of a total knee construct. The subject augments are intended for uncemented biologic fixation.
- 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.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
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.
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)
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.
Clinical Performance Data/Information: 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.
K093293, K121149, K072336, K102896
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/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 Drive |
| P.O. Box 587 | |
| Warsaw, IN 46581-0857 | |
| Establishment | |
| Registration Number | 1825034 |
| Name of contact person | Jason Heckaman |
| Regulatory Affairs Project Manager | |
| Phone number | (574) 371-3707 |
| Fax number | (574) 372-1683 |
| Date prepared | July 30, 2014 |
| Name of device | |
| Trade or proprietary | |
| name | Vanguard® 360 OsseoTi™ Tibial Sleeve Augments |
| Common or usual | |
| name | Knee Prosthesis |
| Classification name | Knee joint patellofemorotibial metal/polymer porous-coated |
| uncemented prosthesis (21CFR §888.3565) | |
| Classification panel | Orthopedic |
| Regulation | 21 CFR §888.3565 |
| Product Code(s) | MBH, JWH |
| Legally marketed device(s) | |
| to which equivalence is | |
| claimed | K093293 Vanguard 360 Revision Knee System |
| K121149 Vanguard SSK 360 Revision Knee System | |
| K072336 Regenerex Porous Titanium Sleeve Augments | |
| K102896 Zimmer Trabecular Metal Tibial Cone Augments | |
| Reason for 510(k) | |
| submission | The Vanguard 360 OsseoTi Tibial Sleeve Augments are new |
| products that are an addition to the Biomet® Vanguard® 360 | |
| Knee 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 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. | |
| Intended use of the device | The Vanguard 360 OsseoTi Revision Sleeve Tibial Augments are |
| optional components intended to be used with the previously | |
| cleared Vanguard 360 Revision Knee System as part of a total | |
| knee construct. The subject augments are intended for | |
| uncemented biologic fixation. | |
| Indications for use | 1. 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.
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
1
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
2
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.
3
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
4
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
5
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)
Image /page/5/Picture/15 description: The image shows the text "Elizabeth L. Frank -S" at the top. Below that is the date and time "2014 07.30 16:50:12". Finally, at the bottom is the text "-04'00'".
Page 1 of 1
Division of Orthopedic Devices