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

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K121771 (44)

P.O. Box 708 Warsaw. IN 46581-0708 574 267-6131

Image /page/0/Picture/2 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized "Z" inside, and the word "zimmer" is written in lowercase letters below the circle. The "Z" is bold and appears to be made of two curved lines.

NOV 7 2012

TX Summary of Safety and Effectiveness

Sponsor:

Contact Person:

Date:

Trade Name:

Product Codes / Device:

Regulation Numbers / Description:

Predicate Device:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Kelli Anderson Project Manager, Regulatory Affairs Telephone: (574) 371-8087 Fax: (574) 372-4605

June 12, 2012

Zimmer® Persona™ Personalized Knee System

MBH, OIY, JWH

21 CFR § 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis

21 CFR & 888.3560 -- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

21 CFR § 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented

PersonaTM Personalized Knee System (K113369, cleared March 27, 2012)

NexGen® Trabecular Metal™ Metal Tibial Tray (K072160, cleared September 5, 2007)

Vivacit-E® Vitamin E Highly Crosslinked Polyethylene Liners, manufactured by Zimmer, Inc. (K120370, cleared June 4, 2012)

EITM Antioxidant Infused Technology, Manufactured by Biomet Manufacturing Corp. (K100048, cleared March 9, 2010)

DePuy Attune Knee System, manufactured by DePuy Orthopaedics, Inc. (K101433, cleared December 10, 2010)

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K121771 (²/₄)

Device Description:

Intended Use:

This device is indicated for patients with severe knee pain and disability due to:

Rheumatoid arthritis, osteoarthritis, traumatic arthritis, । polyarthritis.
Collagen disorders, and/or avascular necrosis of the ເ · 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 l 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.

The proposed Zimmer® Persona™ Personalized Knee System components are similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

Non-Clinical Performance and Conclusions:

Vivacit-E material characteristics for the Persona Knee System are identical to the predicate Zimmer Vivacit-E Acetabular Polyethylene Liners (K120370). In contrast to conventional polyethylene, the Vivacit-E material is delamination resistant and exhibits a reduction in wear according to knee simulator bench testing.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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Bench testing outlined below was conducted according to FDA guidance documents:

Property orCharacteristic	Test Results
Cantilever Fatigue Test of thePersona Trabecular Metal Tibia	Demonstrated adequate fatigue strength in the cantileverloading condition.
Wear Testing of Persona CRVivacit-E UHMWPE ArticularSurfaces Under Load and MotionCurves From the ISO 14243Standard	Demonstrated that the wear characteristics of the PersonaCR articular surfaces, when articulated against the PersonaCR femoral component, are sufficient to survive expected invivo loading conditions.
Wear Testing of Persona PS Vivacit-E UHMWPE Articular SurfacesUnder Load and Motion Curvesfrom the ISO 14243 Standard	Demonstrated that the wear characteristics of the Persona PSand UC articular surfaces, when articulated against aPersona femoral component, are sufficient to surviveexpected in vivo loading conditions.
Spine Fatigue Evaluation of thePersona PS Vivacit-E ArticularSurfaces	Demonstrated that the spine of the Persona PS Vivacit-Earticular surfaces has sufficient strength to survive expectedin vivo stress/strain loading conditions.
Tibiofemoral Constraint Evaluationof the Persona CR/PS/UC Vivacit-EUHMWPE Articular Surface	Demonstrated that constraint values for the Persona Vivacit-E articular surfaces are comparable to data from the PersonaConventional UHMWPE articular surfaces. Therefore, thePersona Vivacit-E articular surfaces provide adequateconstraint through the needed tibiofemoral flexion angles.
Persona Vivacit-E Patella ContactArea, Contact Pressure, andConstraint Evaluation	Evaluated material properties of Vivacit-E and demonstratedthat when mated with a Persona femoral component, it hassufficient mechanical strength to survive expected in-vivoloading conditions and provide adequate constraint.
Tibiofemoral Contact Area andContact Pressure Evaluation of thePersona CR/UC/PS Vivacit-EUHMWPE Articular Surfaces	Demonstrated that the contact area and contact pressure ofthe Persona Vivacit-E articular surfaces are comparable todata from previous testing on Persona ConventionalUHMWPE articular surfaces.
Property orCharacteristic	Test Results
Anterior Liftoff Testing of thePersona Vivacit-E ArticularSurfaces	Demonstrated sufficient locking mechanism strength tosurvive potential worst case anterior liftoff loadingconditions during deep flexion.
Posterior Liftoff Fatigue Strength ofthe Persona Vivacit-E ArticularSurfaces	Demonstrated sufficient locking mechanism strength tosurvive potential worst case shear loading conditions.
Static Shear Strength of the PersonaTibia Locking Mechanism	Demonstrated adequate resistance of the modular articularsurfaces to disassembly.
Modified Metallic SurfaceCharacterization for the PersonaPorous Two Peg Tibia Componentwith Trabecular Metal	Evaluated the Trabecular Metal material according toapplicable mechanical, physical and chemical analyses listedin the guidance document.
Static Tensile, Static Shear andShear Fatigue of Trabecular MetalDiffusion Bonded to Tivanium -One Hour Cycles	Demonstrated that one hour diffusion bonding cyclesproduces a bond that meets the 20 MPa static tensile testrequirement.
Evaluation of Interactions of theZimmer Legacy Knee and PersonaPrimary Implant Systems with theMagnetic Fields in the MagneticResonance Imaging (MRI)Environment	Demonstrated safety and compatibility within the MRIenvironment.

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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 20993-002

NOV 7 2012

Zimmer. Inc. % Ms. Kelli J. Anderson Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K121771

Trade/Device Name: Persona™ 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, OIY Dated: September 21, 2012 Received: September 24, 2012

Dear Ms. Anderson:

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

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Page 2 - Ms. Kelli J. Anderson

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 | 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): Unknown K |2177 |

Device Name:

Persona™ Knee System

Indications for Use:

This device is indicated for patients with severe knee pain and disability due to:

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 ー in flexion cannot be obtained at the time of surgery.

Porous coated tibial baseplate components may be used cemented (biological fixation). All other femoral, tibial baseplates and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121771

Page 1 of 1

CONFIDENTIAL AND PROPRIETARY INFORMATION EXEMPT FROM DISCLOSURE UNDER FOI

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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.