(145 days)
No
The summary describes a traditional knee prosthesis with no mention of AI or ML in its design, function, or performance studies.
Yes
The device is a knee prosthesis indicated for patients with severe knee pain and disability due to various conditions, aiming to resurface the articulating surfaces of the knee bones. This directly addresses and treats a medical condition.
No
The device is described as a knee prosthesis used to resurface bones, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a "semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones," indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant designed to replace damaged knee joints in patients with various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a modular knee prosthesis, which is a physical implant used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the mechanical properties and durability of the implant, which are relevant for a surgical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
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.
- 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.
Product codes
MBH, OIY, JWH
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.
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:
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.
Bench testing outlined below was conducted according to FDA guidance documents:
| Property or Characteristic | Test Results |
|---|---|
| Cantilever Fatigue Test of the Persona Trabecular Metal Tibia | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Demonstrated sufficient locking mechanism strength to survive potential worst case shear loading conditions. |
| Static Shear Strength of the Persona Tibia Locking Mechanism | 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 | 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 | 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 | Demonstrated safety and compatibility within the MRI environment. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PersonaTM Personalized Knee System (K113369), NexGen® Trabecular Metal™ Metal Tibial Tray (K072160)
Reference Device(s)
Vivacit-E® Vitamin E Highly Crosslinked Polyethylene Liners, manufactured by Zimmer, Inc. (K120370), EITM Antioxidant Infused Technology, Manufactured by Biomet Manufacturing Corp. (K100048), DePuy Attune Knee System, manufactured by DePuy Orthopaedics, Inc. (K101433)
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
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)
1
K121771 (²/₄)
Device Description:
Intended Use:
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.
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):
2
Bench testing outlined below was conducted according to FDA guidance documents:
| Property or
| Characteristic | Test Results |
|---|---|
| Cantilever Fatigue Test of the | |
| Persona Trabecular Metal Tibia | 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 | 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 | 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 | 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 | 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 | 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 | 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. | |
| Property or | |
| Characteristic | Test Results |
| Anterior Liftoff Testing of the | |
| Persona Vivacit-E Articular | |
| Surfaces | 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 | Demonstrated sufficient locking mechanism strength to |
| survive potential worst case shear loading conditions. | |
| Static Shear Strength of the Persona | |
| Tibia Locking Mechanism | 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 | 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 | 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 | Demonstrated safety and compatibility within the MRI |
| environment. |
3
.
4
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
5
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
6
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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