(89 days)
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 in flexion cannot be obtained at the time of surgery.
Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.
The Persona™ Personalized Knee System is a semiconstrained 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. The addition of the Trabecular Metal™ femoral component will provide surgeons with the ability to implant with, or without cement (biological fixation).
The Zimmer® Persona™ Personalized Knee System is a medical device for knee replacement. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing an extensive study report with detailed acceptance criteria and performance metrics typically found in efficacy trials.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Clinical data and conclusions were not needed for this device" because it is a Class II device demonstrating substantial equivalence to existing predicate devices. Therefore, the acceptance criteria are met by demonstrating that the new device exhibits similar or identical performance characteristics to these predicate devices through non-clinical (bench) testing. The acceptance criteria are implicit in the FDA guidance documents followed for testing.
| Property or Characteristic | Acceptance Criteria (Implicit from FDA Guidance) | Reported Device Performance |
|---|---|---|
| Posterior Condyle Fatigue Testing in a Cantilever Loading Condition of the Persona™ Trabecular Metal™ femoral component | Adequate posterior condyle fatigue strength as defined by FDA Guidance: Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses. (The specific quantitative acceptance value is not stated in this summary, but would be detailed in the full test report). | Demonstrated adequate posterior condyle fatigue strength of the uncemented Persona™ Trabecular Metal™ femoral component in the cantilever loading condition. |
| Posterior Condyle Fatigue of Persona™ Trabecular Metal™ femoral component in three-point Bend Loading Condition | Adequate posterior condyle fatigue performance as defined by FDA Guidance: Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses. (The specific quantitative acceptance value is not stated in this summary). | Demonstrated adequate posterior condyle fatigue performance of the Persona™ Trabecular Metal™ femoral component in a 3-point bend loading condition. |
| Modified Metallic Surface Characterization for the Persona™ Trabecular Metal™ Porous femoral knee component with Trabecular Metal™ | Mechanical, physical, and chemical analyses in accordance with the Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement. (Specific quantitative acceptance metrics for these analyses are not stated in this summary). | Mechanical, physical, and chemical analyses of Trabecular Metal™ were assessed in accordance with the Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement. (Implied that the results met the requirements of the guidance). |
| Static Tensile, Static Shear and Shear Fatigue of Trabecular Metal™ Diffusion Bonded to Zimaloy-One Hour Cycles, 0.28mm Ti Sheet Interlayer | Bond strength that met the 20 MPa static tensile test and static shear acceptance criteria. (The specific acceptance criteria for shear fatigue, if numerical, are not explicitly stated, but are implied to be met). | Demonstrated that one hour diffusion bonding cycles for Trabecular Metal™ produces a bond that met the 20 MPa static tensile test and static shear acceptance criteria. |
| 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, as defined by FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. (Specific quantitative acceptance metrics for MR safety, such as temperature rise or artifact size, are not stated in this summary). | Demonstrated safety and compatibility within the MRI environment. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (number of components tested) for each non-clinical bench test. These details would typically be found in the full test protocols and reports, but are not included in this summary.
- Data Provenance: The data provenance is "Non-Clinical Performance and Conclusions," meaning the tests were conducted in a laboratory setting (bench testing) rather than on human subjects. This is not retrospective or prospective clinical data. The location of the testing laboratories is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This is not applicable. For bench testing of medical devices like knee implants, ground truth is established by engineering specifications, material properties, and relevant industry standards (e.g., ISO, ASTM), rather than expert medical consensus on patient cases. The "experts" involved are likely engineering and materials science professionals who design and conduct the tests according to the FDA guidance.
4. Adjudication Method for the Test Set:
This is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert opinions on clinical data are resolved. Since this submission relies on non-clinical bench testing, such an adjudication method is not relevant. The "adjudication" is essentially the adherence to pre-defined test protocols and acceptance criteria based on FDA guidance and 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:
Not applicable. This device is a knee implant, not an AI-powered diagnostic tool requiring MRMC studies to assess the impact of AI on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. As above, this is a physical implant, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical tests is established by:
- Engineering Specifications: Designed tolerances, material strengths, and fatigue limits.
- Industry Standards: ASTM, ISO, and other relevant standards for orthopedic implant testing.
- FDA Guidance Documents: The specific guidance documents cited (e.g., Class II Special Controls Guidance Document for Knee Joints, Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces, Guidance for MR Safety) define the methods and performance expectations for validating the device's properties.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for such a device would be the extensive research and development phases involving finite element analysis, material science studies, and repeated experimental bench testing, but these are not considered "training sets" in the context of AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the AI sense for this device.
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Image /page/0/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle, with the word "zimmer" written in lowercase letters below the circle. The logo is black and white.
K122745 1/4
· P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
DEC 0 5 2012
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
Pauline A. Shand Sr. Specialist, Regulatory Affairs Telephone: (574) 372-4765 Fax: (574) 372-4605
September 20, 2012
Zimmer® Persona™ Personalized Knee System
MBH, JWH, OIY
21 CFR & 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
21 CFR § 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented
Persona™ Personalized Knee System (K113369, cleared March 27, 2012)
NexGen® Trabecular Metal™ Metal Tibial Tray (K072160, cleared September 5, 2007)
NexGen® Complete Knee Solution Cruciate Retaining Flex Femoral (CR Flex) Components, manufactured by Zimmer, Inc. (K023211, cleared October 17, 2002)
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د" - "" - ""
K122745₂/₄
NexGen® LPS-Flex Porous Femoral Component, NexGen Gender Solutions Female (GSF), CR-Flex and LPS-Flex Porous Femoral components, manufactured by Zimmer, Inc. (K072619, cleared November 21, 2007
Device Description:
Intended Use:
The Persona™ Personalized Knee System is a semiconstrained 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. The addition of the Trabecular Metal™ femoral component will provide surgeons with the ability to implant with, or without cement (biological fixation).
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 in flexion cannot be obtained at the time of surgery.
Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.
Comparison to Predicate Device:
The proposed Zimmer® Persona™ Personalized Knee System components are similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices.
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Page 3 しい! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Performance Data (Nonclinical and/or Clinical):
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
34
Non-Clinical Performance and Conclusions:
Bench testing outlined below was conducted according to FDA guidance documents:
FDA Guidance: Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses
FDA Guidance: Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement
FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment
| Property orCharacteristic | Test Results |
|---|---|
| Posterior Condyle Fatigue Testing in aCantilever Loading Condition of thePersonaTM Tracebular MetalTMfemoral component | Demonstrated adequate posterior condyle fatigue strength ofthe uncemented PersonaTM Tracebular MetalTM femoralcomponent in the cantilever loading condition |
| Posterior Condyle Fatigue ofPersonaTM Tracebular MetalTMfemoral component in three-pointBend Loading Condition | Demonstrated adequate posterior condyle fatigueperformance of the PersonaTM Tracebular MetalTM femoralcomponent in a 3-point bend loading condition |
| Modified Metallic SurfaceCharacterization for the PersonaTMTracebular MetalTM Porous femoralknee component with TrabecularMetalTM. | Mechanical, physical, and chemical analyses of TrabecularMetalTM were assessed in accordance to theGuidance Document for Testing Orthopedic Implants withModified Metallic Surfaces Apposing Bone or Bone Cement |
11
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1999 - 1999 - 1999
| Static Tensile, Static Shear and ShearFatigue of Trabecular Metal™Diffusion Bonded to Zimaloy-OneHour Cycles, 0.28mm Ti SheetInterlayer | Demonstrated that one hour diffusion bonding cycles forTrabecular Metal™ produces a bond that met the 20 MPastatic tensile test and static shear acceptance criteria. |
|---|---|
| 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. |
and the comments of the comments of
.
:
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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure. The seal is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter dated: December 5, 2012
Zimmer, Incorporated % Ms. Pauline A. Shand Senior Specialist. Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K122745
Trade/Device Name: Zimmer® Persona™ Personalized Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Codes: MBH, JWH, OIY Dated: September 6, 2012 Received: September 7, 2012 Amended: September 24, 2012
Dear Ms. Shand:
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. Ilsting 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. Pauline A. Shand
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 Pari 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
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): K122745
Device Name:
Zimmer® Persona™ Personalized 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. l
- | 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 components may be used cemented (biological fixation). All other femoral, tibial baseplate, 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)
Krishna Asundi
for (Division Sign-Off) Division of Orthopedic Devices
2012.12.05 11:29:29 -05'00'
Page 1 of 1
§ 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.