(89 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.
Indications For Use:
- I. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved.
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- Correction of varus, valgus, or posttraumatic deformity.
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- 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. 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 to update the locking mechanism cleared in K122160.
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 El 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 trays.
The technological characteristics of the Vanguard™ XP Knee System are the same as those of predicate devices (K122160, K904448, 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 locking bar mechanism. tibial and bearing components of the Vanguard™ XP Knee System 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 K122160 and subject 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 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 (Nonclinical) section.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Biomet Vanguard™ XP Knee System:
Device: Biomet Vanguard™ XP Knee System
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (K132873) focuses on a modification to the locking mechanism of an already cleared knee system. As such, the acceptance criteria are not explicitly numerical performance targets in the sense of a new device's efficacy, but rather a demonstration that the modification does not adversely affect safety and maintains substantial equivalence to predicate devices. The "reported device performance" is essentially that all tests met or exceeded established acceptance criteria, confirming this non-adverse effect.
| Acceptance Criteria Category | Specific Test/Rationale | Reported Device Performance |
|---|---|---|
| Mechanical Stability & Functionality | Tibiofemoral Mechanical Stability / Locking Mechanism Test | Met or exceeded established acceptance criteria |
| Static Locking Mechanism Test | Met or exceeded established acceptance criteria | |
| Tibial Fixation and Cyclic Locking Mechanism Test | Met or exceeded established acceptance criteria | |
| Cyclic Fatigue of Tibial Tray Test | Met or exceeded established acceptance criteria | |
| Tibial/Bearing Assembly Verification Test | Met or exceeded established acceptance criteria | |
| Locking Bar Insertion and Push-Out Test | Met or exceeded established acceptance criteria | |
| Material & Compatibility | MRI Compatibility Rationale | Demonstrated MRI compatibility (based on rationale, not explicit testing results in this summary) |
| Porous plasma spray characterization data (on identical substrate) | Used from K113550, supporting K122160 and the current 510(k), indicating established performance |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (e.g., number of components tested) for each non-clinical test. It only states that the tests were performed.
- Data Provenance: The data is from non-clinical testing (mechanical tests). The origin country is not explicitly stated, but given the submitter and FDA context, it is presumed to be conducted under standards relevant to the US market. The nature of the study is purely retrospective in the sense that it's testing a modified device against established standards and predicate data, not a de novo prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This submission relies on non-clinical mechanical testing, not expert-reviewed clinical data or images. The "ground truth" for these tests is the performance against pre-defined engineering and mechanical standards.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this is non-clinical mechanical testing, not a clinical study involving human readers or adjudication. The results are quantitative measurements against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This document explicitly states: "No clinical testing was necessary for a determination of substantial equivalence." Therefore, no MRMC study was conducted. The nature of this submission is a modification to a previously cleared device, relying on non-clinical testing to demonstrate that the modification does not introduce new safety or effectiveness concerns.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This is a physical prosthetic device (a knee system), not an algorithm or AI-based device. "Standalone performance" in this context would refer to the mechanical performance of the device components themselves, which was assessed through non-clinical testing.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical tests is based on:
- Pre-defined engineering standards and mechanical test protocols (e.g., for fatigue, stability, locking mechanism integrity).
- Performance data from legally marketed predicate devices (K122160, K113550, K904448), to which substantial equivalence is claimed.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context. The manufacturing processes and design principles are based on established engineering practices and predicate devices.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set." The design and manufacturing of the device were established through conventional engineering and medical device development processes, drawing upon existing knowledge, materials science, and the performance characteristics of 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.