FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Collagen disorders, and/or avascular necrosis of the femoral condyle.
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities.
The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Porous coated tibial baseplate components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplates and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

Device Description

The Zimmer® Persona™ Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces.

AI/ML Overview

This submission describes the Zimmer Persona Personalized Knee System. The device is a modular knee prosthesis for resurfacing the articulating surfaces of the femoral, tibial, and patellar bones. The submission focuses on non-clinical performance and a comparison of the device's material characteristics to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Property or Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Cantilever Fatigue Test of the Persona Trabecular Metal Tibia	Adequate fatigue strength in cantilever loading conditions. (Implied, to survive in vivo)	Demonstrated adequate fatigue strength in the cantilever loading condition.
Wear Testing of Persona CR Vivacit-E UHMWPE Articular Surfaces Under Load and Motion Curves From the ISO 14243 Standard	Sufficient wear characteristics to survive expected in vivo loading conditions. (Implied, to meet ISO 14243 standards)	Demonstrated that the wear characteristics of the Persona CR articular surfaces, when articulated against the Persona CR femoral component, are sufficient to survive expected in vivo loading conditions.
Wear Testing of Persona PS Vivacit-E UHMWPE Articular Surfaces Under Load and Motion Curves from the ISO 14243 Standard	Sufficient wear characteristics to survive expected in vivo loading conditions. (Implied, to meet ISO 14243 standards)	Demonstrated that the wear characteristics of the Persona PS and UC articular surfaces, when articulated against a Persona femoral component, are sufficient to survive expected in vivo loading conditions.
Spine Fatigue Evaluation of the Persona PS Vivacit-E Articular Surfaces	Sufficient strength to survive expected in vivo stress/strain loading conditions. (Implied)	Demonstrated that the spine of the Persona PS Vivacit-E articular surfaces has sufficient strength to survive expected in vivo stress/strain loading conditions.
Tibiofemoral Constraint Evaluation of the Persona CR/PS/UC Vivacit-E UHMWPE Articular Surface	Comparable constraint values to predicate Persona Conventional UHMWPE articular surfaces and adequate constraint through needed tibiofemoral flexion angles. (Implied, to ensure stability)	Demonstrated that constraint values for the Persona Vivacit-E articular surfaces are comparable to data from the Persona Conventional UHMWPE articular surfaces. Therefore, the Persona Vivacit-E articular surfaces provide adequate constraint through the needed tibiofemoral flexion angles.
Persona Vivacit-E Patella Contact Area, Contact Pressure, and Constraint Evaluation	Sufficient mechanical strength to survive expected in vivo loading conditions and adequate constraint when mated with a Persona femoral component. (Implied)	Evaluated material properties of Vivacit-E and demonstrated that when mated with a Persona femoral component, it has sufficient mechanical strength to survive expected in vivo loading conditions and provide adequate constraint.
Tibiofemoral Contact Area and Contact Pressure Evaluation of the Persona CR/UC/PS Vivacit-E UHMWPE Articular Surfaces	Comparable contact area and contact pressure to data from previous testing on Persona Conventional UHMWPE articular surfaces. (Implied, to maintain similar biomechanical performance)	Demonstrated that the contact area and contact pressure of the Persona Vivacit-E articular surfaces are comparable to data from previous testing on Persona Conventional UHMWPE articular surfaces.
Anterior Liftoff Testing of the Persona Vivacit-E Articular Surfaces	Sufficient locking mechanism strength to survive potential worst case anterior liftoff loading conditions during deep flexion. (Implied, to prevent dislocation)	Demonstrated sufficient locking mechanism strength to survive potential worst case anterior liftoff loading conditions during deep flexion.
Posterior Liftoff Fatigue Strength of the Persona Vivacit-E Articular Surfaces	Sufficient locking mechanism strength to survive potential worst case shear loading conditions. (Implied, to prevent dislocation)	Demonstrated sufficient locking mechanism strength to survive potential worst case shear loading conditions.
Static Shear Strength of the Persona Tibia Locking Mechanism	Adequate resistance of the modular articular surfaces to disassembly. (Implied, to ensure structural integrity)	Demonstrated adequate resistance of the modular articular surfaces to disassembly.
Modified Metallic Surface Characterization for the Persona Porous Two Peg Tibia Component with Trabecular Metal	Meets applicable mechanical, physical, and chemical analyses listed in the guidance document. (Implied, for material safety and performance)	Evaluated the Trabecular Metal material according to applicable mechanical, physical and chemical analyses listed in the guidance document.
Static Tensile, Static Shear and Shear Fatigue of Trabecular Metal Diffusion Bonded to Tivanium - One Hour Cycles	Bond meets the 20 MPa static tensile test requirement. (Implied, for bond strength)	Demonstrated that one hour diffusion bonding cycles produces a bond that meets the 20 MPa static tensile test requirement.
Evaluation of Interactions of the Zimmer Legacy Knee and Persona Primary Implant Systems with the Magnetic Fields in the Magnetic Resonance Imaging (MRI) Environment	Safety and compatibility within the MRI environment. (Implied, for patient safety)	Demonstrated safety and compatibility within the MRI environment.

2. Sample Sizes and Data Provenance:

Test Set Sample Size: The document does not specify exact sample sizes for each test. However, it indicates that "bench testing outlined below was conducted according to FDA guidance documents," which implies that appropriate sample sizes were used as per relevant standards (e.g., ISO 14243 for wear testing).
Data Provenance: The data is from non-clinical bench testing performed by Zimmer, Inc., a company located in Warsaw, IN, USA. This is prospective data generated specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This submission relies on non-clinical bench testing, not expert-derived ground truth from human data. The "ground truth" for these tests comes from established engineering and biocompatibility standards and predicate device performance.

4. Adjudication Method:

Not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers/experts to resolve discrepancies in interpretation. This submission focuses on objective bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This submission describes the clearance of a medical device based on non-clinical performance data and substantial equivalence to predicate devices, not a comparative effectiveness study involving human readers or AI.

6. Standalone Performance (Algorithm Only):

Not applicable. This device is a physical knee prosthesis, not an AI algorithm. Its "performance" is assessed through its mechanical, wear, and material characteristics, not through algorithmic accuracy.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is derived from:
- Established engineering standards: Such as ISO 14243 for wear testing.
- FDA guidance documents: Which outline appropriate test methodologies and performance expectations for orthopedic implants.
- Predicate device characteristics: The Vivacit-E material characteristics for the Persona Knee System are stated to be "identical to the predicate Zimmer Vivacit-E Acetabular Polyethylene Liners (K120370)," and other performance metrics are compared to "Persona Conventional UHMWPE articular surfaces."

8. Sample Size for Training Set:

Not applicable. This submission describes a physical medical device, not an AI system that requires a "training set."

9. How Ground Truth for Training Set was Established:

Not applicable. As above, there is no AI training set involved.

Summary

Regulation Number and Section

§ 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.