(89 days)
No
The summary describes a mechanical knee prosthesis and bench testing for its performance and compatibility. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a knee prosthesis designed to resurface articulating surfaces to alleviate severe knee pain and disability, which aligns with the definition of a therapeutic device.
No
Explanation: This device is a knee prosthesis designed to resurface bone surfaces, functioning as a therapeutic implant rather than a diagnostic tool.
No
The device description clearly states it is a "semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones," which are physical components. The performance studies also focus on the mechanical properties and fatigue strength of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The provided description clearly states that the Persona™ Personalized Knee System is a modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. This is a surgical implant used within the body to replace damaged joint components.
- Intended Use: The intended use describes the conditions for which the knee prosthesis is indicated (severe knee pain and disability due to various forms of arthritis, etc.). This is a clinical indication for a surgical procedure, not a diagnostic test.
- Device Description: The description focuses on the physical components of the implant (femoral, tibial, patellar components, Trabecular Metal™).
- Performance Studies: The performance studies described are bench tests evaluating the mechanical strength and compatibility of the implant materials, not studies evaluating the accuracy of a diagnostic test.
The device is a surgical implant, specifically a knee prosthesis, not a diagnostic tool that analyzes samples from the body.
N/A
Intended Use / 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.
Product codes
MBH, JWH, OIY
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 or Characteristic: Posterior Condyle Fatigue Testing in a Cantilever Loading Condition of the PersonaTM Tracebular MetalTM femoral component
Test Results: Demonstrated adequate posterior condyle fatigue strength of the uncemented PersonaTM Tracebular MetalTM femoral component in the cantilever loading condition
Property or Characteristic: Posterior Condyle Fatigue of PersonaTM Tracebular MetalTM femoral component in three-point Bend Loading Condition
Test Results: Demonstrated adequate posterior condyle fatigue performance of the PersonaTM Tracebular MetalTM femoral component in a 3-point bend loading condition
Property or Characteristic: Modified Metallic Surface Characterization for the PersonaTM Tracebular MetalTM Porous femoral knee component with Trabecular MetalTM.
Test Results: Mechanical, physical, and chemical analyses of Trabecular MetalTM were assessed in accordance to the Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement
Property or Characteristic: Static Tensile, Static Shear and Shear Fatigue of Trabecular Metal™ Diffusion Bonded to Zimaloy-One Hour Cycles, 0.28mm Ti Sheet Interlayer
Test Results: 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.
Property or Characteristic: Evaluation of Interactions of the Zimmer Legacy Knee and Persona Primary Implant Systems with the Magnetic Fields in the Magnetic Resonance Imaging (MRI) Environment
Test Results: Demonstrated safety and compatibility within the MRI environment.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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), 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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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)
1
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.
2
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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 or
| Characteristic | Test Results |
|---|---|
| Posterior Condyle Fatigue Testing in a | |
| Cantilever Loading Condition of the | |
| PersonaTM Tracebular MetalTM | |
| femoral component | Demonstrated adequate posterior condyle fatigue strength of |
| the uncemented PersonaTM Tracebular MetalTM femoral | |
| component in the cantilever loading condition | |
| Posterior Condyle Fatigue of | |
| PersonaTM Tracebular MetalTM | |
| femoral component in three-point | |
| Bend Loading Condition | Demonstrated adequate posterior condyle fatigue |
| performance of the PersonaTM Tracebular MetalTM femoral | |
| component in a 3-point bend loading condition | |
| Modified Metallic Surface | |
| Characterization for the PersonaTM | |
| Tracebular MetalTM Porous femoral | |
| knee component with Trabecular | |
| MetalTM. | Mechanical, physical, and chemical analyses of Trabecular |
| MetalTM were assessed in accordance to the | |
| Guidance Document for Testing Orthopedic Implants with | |
| Modified Metallic Surfaces Apposing Bone or Bone Cement |
11
3
1999 - 1999 - 1999
| Static Tensile, Static Shear and Shear
Fatigue of Trabecular Metal™
Diffusion Bonded to Zimaloy-One
Hour Cycles, 0.28mm Ti Sheet
Interlayer | 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 | Demonstrated safety and compatibility within the MRI
environment. |
and the comments of the comments of
.
:
4
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
5
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
6
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'
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