(243 days)
Not Found
No
The summary describes a mechanical knee replacement system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "replacement of a total knee joint," addressing "painful and disabled knee joint" conditions and deformities, which aligns with the definition of a therapeutic device.
No
This device is a total knee replacement system, which is a therapeutic device intended for surgical implantation to replace a damaged knee joint, not to diagnose a condition.
No
The device description clearly states it is a total knee replacement system consisting of physical components like femoral components, tibial trays, and bearings, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Vanguard™ XP Knee System is for the replacement of a total knee joint. This is a surgical procedure performed in vivo (within the body).
- Device Description: The device description details the components of a knee implant (femoral component, tibial trays, bearings, patellae). These are physical implants designed to be surgically placed in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The Vanguard™ XP Knee System is intended for replacement of a total knee joint and the preservation of the anterior and/or posterior cruciate ligament (ACL/PCL) when used in conjunction with a femoral, tibial and patellar component.
Specific indications are as follows:
- 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. Regenerex components are intended only for uncemented biologic fixation application.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH, MBV, OIY
Device Description
The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of Co-Cr-Mo, two styles of tibial trays/plates manufactured of Co-Cr-Mo (with locking bar), and dual bearings machined of E1 poly. Biomet® patellae can be used with the Vanguard XP Knee System. Both the XP femoral and the XP-CR tibial components are available with a previously cleared porous plasma spray (PPS) coating of titanium alloy and Biomet's Interlok® coarse blasted finishes. The Vanguard XP-XP tibial components are available in Biomet's Interlok® coarse blasted finish. Porous coated femoral and tibial components are indicated for cemented and uncemented biological fixation application. Non-coated coarse blasted (Interlok®) femoral and tibial components are indicated for cemented application only. Accessory components are available including removable femoral pegs and femoral augments.
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:
The following tests were performed for the new Vanguard® XP Knee System:
- Tibiofemoral Mechanical Stability
- Static Locking Mechanism
- Fixation and Cyclic Locking Mechanism
- Wear Test
- Cyclic Fatique of Tibial Tray
- Surface Roughness Analysis
- Tibiofemoral Constraint
- Tibiofemoral Contact Area
- Femoral Section Analysis
- ROM Analysis
- Tibial/Bearing Assembly
- MRI Analysis and Justification
- Surgical Instrument Cadaver Validations
- Bearing Fatique Tests
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.
K113550, K102580, K080528, K904448, K833363, K031061, K050222, K961021, K921182, K993159
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.
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Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with each letter enclosed in a box. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The logo is black and white.
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 |
| Warsaw, IN 46581-0857 | |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| Establishment | |
| Registration Number | 1825034 |
| Name of contact | |
| person | Tracy Bickel Johnson, RAC |
| Date prepared | January 14, 2014 |
| Name of device | |
| Trade or proprietary | |
| name | Vanguard™ XP Knee System |
| Common or usual | |
| name | Knee Prosthesis |
| Classification name | Knee joint patellofemorotibial metal/polymer porous- |
| coated uncemented prosthesis (§888.3565) | |
| Knee joint patellofemorotibial polymer/metal/polymer semi- | |
| constrained cemented prosthesis (§888.3560) | |
| Knee joint patellofemorotibial semi-constrained UHMWPE | |
| pegged uncemented polymer/metal/polymer (§888.3560) | |
| Knee joint patellofemorotibial | |
| polymer+Additive/metal/polymer +Additive semi- | |
| constrained cemented prosthesis (§888.3560) | |
| Classification panel | Orthopedic |
| Regulation | 21CFR §888.3565 |
| 21CFR §888.3560 | |
| Product Code(s) | JWH, MBH, MBV, OIY |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | K113550 Vanguard™ Knee System (JWH, MBH, OIY) |
| K102580 Vanguard™ Removable Molded Poly Tibia (JWH) | |
| K080528 E1™ Tibial Bearings (OIY, JWH, MBH, MBV) | |
| K904448 Townley Total Knee (JWH) | |
| K833363 Cloutier II Fiber Metal Total Knee (JWH) | |
| K031061 NexGen® Total Knee System (MBH) | |
| K050222 Vanguard™ Anterior Stabilized Tibial Bearings | |
| (JWH, MBH) | |
| K961021 Kirschner Knee Modified (JWH) | |
| K921182 Ultra High Molecular Weight Polyethylene (JWH, | |
| HRY) | |
| K993159 Maxim Knee System (JWH) | |
| Reason for 510(k) | |
| submission | Additional Vanguard® product line to include an XP femoral, |
| ACL/PCL and PCL tibial tray, tibial bearings (AS, XP) and | |
| associated instrumentation. | |
| Device description | The Vanguard XP Knee System is a total knee replacement |
| system that consists of a femoral component composed of | |
| Co-Cr-Mo, two styles of tibial trays/plates manufactured of | |
| Co-Cr-Mo (with locking bar), and dual bearings machined of | |
| E1 poly. Biomet® patellae can be used with the Vanguard | |
| XP Knee System. Both the XP femoral and the XP-CR tibial | |
| components are available with a previously cleared porous | |
| plasma spray (PPS) coating of titanium alloy and Biomet's | |
| Interlok® coarse blasted finishes. The Vanguard XP-XP | |
| tibial components are available in Biomet's Interlok® | |
| coarse blasted finish. Porous coated femoral and tibial | |
| components are indicated for cemented and uncemented | |
| biological fixation application. Non-coated coarse blasted | |
| (Interlok®) femoral and tibial components are indicated for | |
| cemented application only. Accessory components are | |
| available including removable femoral pegs and femoral | |
| augments. | |
| Intended use of the | |
| device | The Vanguard™ XP Knee System is intended for replacement |
| of a total knee joint and the preservation of the anterior | |
| and/or posterior cruciate ligament (ACL/PCL) when used in | |
| conjunction with a femoral, tibial and patellar component. | |
| Indications for use | Specific indications are as follows: |
- 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 |
56 East Bell Drive Warsaw, IN 46582
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Image /page/1/Picture/1 description: The image shows the logo for ROMET MANUFACTURING CORP. The word "ROMET" is in a stylized font with each letter outlined. Below the logo is the text "MANUFACTURING CORP." in a simple, sans-serif font.
・
.
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Image /page/2/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized font with each letter enclosed in a square. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.
biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application.
Summary of the Technologies
The Vanguard" XP Knee System is made up of multiple components, including: instrumentation, femoral components, several types of bearings and tibial trays.
The technological characteristics of the Vanguard™ XP Knee System are the same as those of predicate devices (K113550, K102580, K080528, K050222, K904448, K833363, and K031061) in terms of design, material, and principle of operation with the exception of slight modifications as described in this 510(k). The femoral and tibial components of the Vanguard™ XP Knee System utilize the identical manufacturing processes as the predicates (K113550, K080528, and K102580). The previously provided porous plasma spray characterization data in K113550 was used in support of this 510(k). The porous plasma spray coating on the ASTM F75 substrate is for both cemented and uncemented, biologic fixation. Non-clinical testing was conducted to demonstrate that the differences did not adversely affect safety and efficacy, and to demonstrate substantial equivalence to the predicate components. All testing met or exceeded the established acceptance criteria. This information is detailed below in the Performance (Non-clinical) section.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS
Performance Test Summary-New Device
The following tests were performed for the new Vanguard® XP Knee System:
- . Tibiofemoral Mechanical Stability
- Static Locking Mechanism
- Fixation and Cyclic Locking Mechanism
- Wear Test .
- Cyclic Fatique of Tibial Tray ●
- Surface Roughness Analysis ●
- Tibiofemoral Constraint .
- . Tibiofemoral Contact Area
- Femoral Section Analysis .
- ROM Analysis
- Tibial/Bearing Assembly
- MRI Analysis and Justification
- Surgical Instrument Cadaver Validations
- Bearing Fatique Tests ●
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF
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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.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
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
March 20, 2013
Biomet, Incorporated % Ms. Tracy Bickel Johnson, RAC Global Regulatory Project Manger 56 East Bell Drive Warsaw, Indiana 46581
Re: K122160
Trade/Device Name: Vanguard™ XP Knee System 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, MBV, OIY Dated: March 8, 2013 . . Received: March 11, 2013
Dear Ms. Johnson:
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 (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
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Page 2 - Ms. Tracy Bickel Johnson, RAC
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/CDRH/CDRHOffices/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.
Sincerely yours,
Erin J. Keith
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Vanguard™ XP Knee System
Indications For Use:
-
Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or 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 uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application.
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)
Casey L. Hanley, Ph.D.
Division of Orthopaedic Devices
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