(243 days)
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.
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.
This document is a 510(k) summary for the Vanguard™ XP Knee System, a knee replacement device. It establishes substantial equivalence to previously cleared predicate devices through non-clinical performance testing.
Here's an analysis of the provided information, focusing on acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside performance data with specific numerical values or success/failure metrics. Instead, it lists various non-clinical tests performed and states:
"All testing met or exceeded the established acceptance criteria."
This indicates that acceptance criteria were internally defined and met, but the specific thresholds and quantitative results are not disclosed in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document relates to non-clinical (mechanical) testing of a medical device (knee implant components). These types of tests typically do not involve human subjects or retrospective/prospective data from patients.
- Sample size for the test set: Not explicitly stated but implied to be sufficient for mechanical testing according to established standards. The tests mentioned (e.g., Tibiofemoral Mechanical Stability, Cyclic Fatigue of Tibial Tray, Wear Test) would involve multiple samples of the components under various load conditions.
- Data provenance: Not applicable in the context of human data. The tests were performed on the device components themselves.
- Retrospective or prospective: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable as the study involves non-clinical mechanical testing of an orthopedic implant, not medical image analysis or clinical diagnosis. Ground truth would be defined by engineering specifications and physical measurements, rather than expert clinical consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept applies to clinical studies or studies where human expert review is required to establish ground truth or evaluate outcomes, typically in image analysis or diagnostic contexts. For mechanical testing, outcomes are determined by physical measurements against predefined engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation systems, which is not the nature of this medical device (a knee implant). The submission focuses on demonstrating the physical and mechanical performance of the implant components.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance study was not done. This is not an AI/software device. The product is a physical knee implant system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this type of non-clinical performance data is based on engineering specifications, established industry standards (e.g., ASTM standards for medical devices), and predefined physical and mechanical thresholds. For example, a wear test would have an acceptance criterion for maximum allowable material loss after a certain number of cycles, and the "ground truth" is measured wear, compared against this criterion. Similarly, fatigue tests would have criteria for the number of cycles to failure at a given load.
8. The sample size for the training set
Not applicable. This device is a physical implant, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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 DriveWarsaw, IN 46581-0857 |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| EstablishmentRegistration Number | 1825034 |
| Name of contactperson | Tracy Bickel Johnson, RAC |
| Date prepared | January 14, 2014 |
| Name of device | |
| Trade or proprietaryname | Vanguard™ XP Knee System |
| Common or usualname | 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 UHMWPEpegged uncemented polymer/metal/polymer (§888.3560)Knee joint patellofemorotibialpolymer+Additive/metal/polymer +Additive semi-constrained cemented prosthesis (§888.3560) |
| Classification panel | Orthopedic |
| Regulation | 21CFR §888.356521CFR §888.3560 |
| Product Code(s) | JWH, MBH, MBV, OIY |
| Legally marketeddevice(s) to whichequivalence 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) andassociated instrumentation. |
| Device description | The Vanguard XP Knee System is a total knee replacementsystem that consists of a femoral component composed ofCo-Cr-Mo, two styles of tibial trays/plates manufactured ofCo-Cr-Mo (with locking bar), and dual bearings machined ofE1 poly. Biomet® patellae can be used with the VanguardXP Knee System. Both the XP femoral and the XP-CR tibialcomponents are available with a previously cleared porousplasma spray (PPS) coating of titanium alloy and Biomet'sInterlok® coarse blasted finishes. The Vanguard XP-XPtibial components are available in Biomet's Interlok®coarse blasted finish. Porous coated femoral and tibialcomponents are indicated for cemented and uncementedbiological fixation application. Non-coated coarse blasted(Interlok®) femoral and tibial components are indicated forcemented application only. Accessory components areavailable including removable femoral pegs and femoralaugments. |
| Intended use of thedevice | The Vanguard™ XP Knee System is intended for replacementof a total knee joint and the preservation of the anteriorand/or posterior cruciate ligament (ACL/PCL) when used inconjunction with a femoral, tibial and patellar component. |
| Indications for use | Specific indications are as follows:1. Painful and disabled knee joint resulting fromosteoarthritis, rheumatoid arthritis, traumatic arthritis whereone or more compartments are involved.2. Correction of varus, valgus, or posttraumatic deformity.3. Correction or revision of unsuccessful osteotomy,arthrodesis, or failure of previous total joint replacementprocedure.Femoral components and tibial tray components with porouscoatings are indicated for cemented and un-cemented |
56 East Bell Drive Warsaw, IN 46582
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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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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
Page 1 of 1
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§ 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.