(152 days)
- 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) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex components* are intended only for uncemented biologic fixation application.
*Where Available
The purpose of the submission is a line extension of the Vanguard XP femoral component. The Vanguard XP femoral component is now compatible with the standard Vanguard bearings components when using Vanguard tibial trays.
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.
The Vanguard XP Knee System is made up of multiple components, including: instrumentation, femoral components, several types of bearings and tibial travs.
The provided text is a 510(k) summary for the Biomet Vanguard XP Knee System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study to prove safety and effectiveness from scratch. Therefore, the information provided aligns with what is typically found in a 510(k) submission and does not describe a study in the way one might expect for a novel AI device or a new drug.
Based on the provided information, I can answer your questions as follows:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and device performance in numerical terms as one might expect for an AI or software-based device with specific metrics like accuracy, sensitivity, or specificity. Instead, the performance is demonstrated through a series of non-clinical tests designed to show that the "line extension" modifications do not adversely affect safety and efficacy compared to the predicate devices. The acceptance criteria essentially were that the tests met or exceeded established standards for knee prostheses.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance | The device's mechanical properties (e.g., wear, constraint, contact area, fatigue, range of motion, surface roughness) for the line extension should be comparable to or better than the predicate devices and meet established orthopedic device standards (e.g., ASTM standards, ISO standards, or internal design specifications for knee prostheses, although specific standard numbers are not given here). The modifications should not adversely affect safety and efficacy. Porous plasma spray coating characterization should be consistent with previously cleared data. Previously cleared P/F contact area and stability testing were used to support unchanged P/F articulating geometry. | "All testing met or exceeded the established acceptance criteria.""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.""The technological characteristics of the Vanguard XP Knee System are the same as those of predicate devices... in terms of design, material, and principle of operation with the exception of slight modifications... The subject Vanguard XP femur modifications utilize the identical manufacturing processes as the predicates. The previously cleared, porous plasma spray characterization data on identical substrate was provided in K113550 and used in support of subject 510(k). Previous P/F contact area and stability testing were provided in support of unchanged P/F articulating geometry." |
| Material Composition | Materials used should be biocompatible and consistent with the predicate devices and established orthopedic standards (e.g., Co-Cr-Mo, E1 poly). | "composed of Co-Cr-Mo," "dual bearings machined of E1 poly." Implied consistency with predicates. |
| MRI Compatibility | The device should be compatible with MRI procedures, or a rationale for its compatibility established. | "MRI Compatibility Rationale" was performed, and the overall conclusion is that the device "did not raise any new safety and efficacy issues." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "non-clinical tests" which are typically laboratory-based mechanical or material tests. It does not specify sample sizes in the context of human subjects or clinical data. No human data (clinical or retrospective/prospective) was used for this 510(k) submission. Therefore, provenance such as "country of origin of the data" or "retrospective/prospective" is not applicable in this context.
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. The product is a physical medical device (knee prosthesis), not a diagnostic algorithm or AI system that requires expert interpretation to establish a ground truth for a test set. Evaluation relies on engineering and materials testing by qualified personnel, not medical experts establishing ground truth for diagnostic images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies or studies involving human expert assessment where there might be disagreement that needs to be resolved. This submission relies on engineering and material testing, which typically have objective measurements against defined 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
This is not applicable. An MRMC study is designed for evaluating diagnostic tools, often involving AI, and comparing human performance with and without AI assistance. The Vanguard XP Knee System is a prosthetic implant, not a diagnostic tool or AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical device like a knee prosthesis, "ground truth" for performance is typically established through:
- Engineering specifications and standards: Adherence to established ASTM (American Society for Testing and Materials) or ISO (International Organization for Standardization) standards for materials, fatigue life, wear, strength, etc.
- Bench testing: Direct measurement of physical properties and performance under simulated physiological conditions.
- Material characterization: Analysis of material composition, surface properties, and coatings.
In this case, the "ground truth" for the non-clinical tests was adherence to either established internal acceptance criteria based on validated methods or industry standards. The previously cleared predicate devices and their established performance also served as a "ground truth" for comparison for the line extension.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable (see point 8).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2014
Biomet, Incorporated Ms. Julie B. Gantenberg, M.S., RAC Senior Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana, 46581
Re: K141407 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: September 29, 2014 Received: October 1, 2014
Dear Ms. Gantenberg:
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 - Ms. Julie B. Gantenberg, M.S.
(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 (OS) 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/Resourcesfor You/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 -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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narket Notification [510(k)] Submission, 21 CFR § 807.87 Vanguard XP Knee System Traditional
Indications for Use
K141407 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 3. joint replacement procedure.
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 components* are intended only for uncemented biologic fixation application.
*Where Available
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Paqe 1/1
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K141407 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 | Julie B. Gantenberg, M.S., RAC |
| Date prepared | September 29, 2014 |
| Name of device | |
| Trade or proprietaryname | Vanguard XP Knee System |
| Common or usualname | Knee Prosthesis |
| Classification name | Knee joint patellofemorotibial metal/polymer porous- coateduncemented 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 patellofemorotibial polymer+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 marketed device(s)to which equivalence isclaimed | K132873 Vanguard XP Knee System (JWH, MBH, MBV, OIY)K122160 Vanguard XP Knee System (JWH, MBH, MBV, OIY)K113550 Vanguard Knee System (JWH, MBH, OIY)K904448 Townley Total Knee (JWH) |
| Reason for 510(k)submission | Line Extension of XP Femoral Component |
Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Office: 574.267.6639 Main Fax: 574.267.8137 www.biomet.com
Shipping Address: 56 East Bell Drive Warsaw, IN 46582
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BIOMET
| Device description | The purpose of the submission is a line extension of the VanguardXP femoral component. The Vanguard XP femoral component isnow compatible with the standard Vanguard bearings componentswhen using Vanguard tibial trays. |
|---|---|
| The Vanguard XP Knee System is a total knee replacementsystem 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 areavailable with a previously cleared porous plasma spray (PPS)coating of titanium alloy and Biomet's Interlok coarse blastedfinishes. The Vanguard XP-XP tibial components are available inBiomet's Interlok coarse blasted finish. Porous coated femoraland tibial components are indicated for cemented and uncementedbiological fixation application. Non-coated coarse blasted(Interlok) femoral and tibial components are indicated forcemented application only. Accessory components are availableincluding removable femoral pegs and femoral augments. | |
| Intended use of the device | The Vanguard XP Knee System is intended for replacement of atotal knee joint and the preservation of the anterior and/or posteriorcruciate ligament (ACL/PCL) when used in conjunction with afemoral, tibial and patellar component. |
| Indications for use | 1. Painful and disabled knee joint resulting from osteoarthritis,rheumatoid arthritis, or 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 total joint replacement procedure.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 components areindicated for cemented application only. Regenerex components*are intended only for uncemented biologic fixation application.*where available |
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The Vanguard XP Knee System is made up of multiple components, including: instrumentation, femoral components, several types of bearings and tibial travs.
The technological characteristics of the Vanguard XP Knee System are the same as those of predicate devices (K132873/K122160 and K113550) in terms of design, material, and principle of operation with the exception of slight modifications as described in this 510(k). The subject Vanguard XP femur modifications utilize the identical manufacturing processes as the predicates. The previously cleared, porous plasma spray characterization data on identical substrate was provided in K113550 and used in support of subject 510(k). The porous plasma spray coating on the ASTM F75 substrate is for both cemented and uncemented, biologic fixation. Previous P/F contact area and stability testing were provided in support of unchanged P/F articulating geometry. The subject 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/rationale were performed for the Vanguard XP Knee System line extension:
- Wear
- T/F Constraint
- T/F Contact Area ●
- P/F Joint Analysis ●
- Range of Motion
- Bearing Fatigue
- Surface Roughness of metallic femoral component
- Femoral Section Analysis
- MRI Compatibility Rationale ●
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF 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.
§ 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.