(133 days)
No
The summary describes a mechanical knee prosthesis and its performance testing, with no mention of AI or ML.
Yes
The device is a knee prosthesis designed to resurface bone, treating severe knee pain and disability caused by various conditions, which are therapeutic goals.
No
The provided information describes a knee prosthesis, which is an implant designed to replace part or all of a knee joint. Its purpose is to treat conditions like arthritis and deformities, not to diagnose them.
No
The device description clearly states it is a "semi-constrained modular knee prosthesis," which is a physical implant, not software. The performance studies also focus on the mechanical properties and wear characteristics of the physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a knee prosthesis) designed to be surgically implanted into a patient's knee joint to replace damaged bone and cartilage. Its intended use is to alleviate pain and disability caused by various knee conditions.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from the body. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Zimmer® Persona™ Personalized Knee System is a medical device, specifically a surgical implant, but not an In Vitro Diagnostic device.
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.
This device is intended for cemented use only.
Product codes
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.
This device is intended for cemented use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (femoral, tibial, and patellar bones)
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:
Fatigue Test of the Persona Tibia Keel and Stem Extension
Demonstrated that the Persona tibia keel and stem extension taper junction provide sufficient fatigue strength to survive expected worst case loading conditions.
Cantilever Fatigue Test of the Persona Cemented Tibia
Demonstrated adequate fatigue strength in the cantilever loading condition.
Wear Testing of Persona CR Conventional 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 Conventional UHMWPE Articular Surfaces Under Load and Motion Curves from the ISO 14243 Standard
Demonstrated that the wear characteristics of the Persona PS articular surfaces, when articulated against the Persona PS femoral component, are sufficient to survive expected in vivo loading conditions.
Wear Testing of Persona UC Conventional UHMWPE Articular Surfaces Under Displacement Control with Load and Motion Curves from the ISO 14243-1 Standard
Demonstrated that the wear characteristics of the Persona UC articular surfaces, when articulated against the Persona CR femoral component, are sufficient to survive expected in vivo loading conditions.
Spine Fatigue Evaluation of the Persona PS Conventional UHMWPE Articular Surfaces
Demonstrated that the spine of the Persona PS articular surfaces has sufficient strength to survive expected in vivo stress/strain loading conditions.
Tibiofemoral Constraint Evaluation of the Persona Conventional UHMWPE Articular Surface
Demonstrated that constraint values for the Persona articular surfaces are comparable to data from similar NexGen articular surfaces. Therefore, the Persona articular surfaces provide adequate constraint through the needed tibiofemoral flexion angles.
Lateral Constraint Evaluation of the Persona Conventional All-Poly Patellar Component on the Persona CR and PS Femoral Components
Demonstrated that the lateral subluxation force of the Persona conventional all-poly patellar component on the Persona CR and PS femoral implants at tibiofemoral flexion angles 0° to 90° was comparable to control testing on NexGen predicate devcies.
Tibiofemoral Contact Area and Contact Pressure Evaluation of the Persona CR/UC/PS Conventional Articular Surfaces
Demonstrated that the contact area and contact pressure of the Persona articular surfaces are comparable to data from previous testing on similar NexGen articular surfaces.
Contact Area and Contact Stress Evaluation of the Persona Conventional All-Poly Patellar Component on the Persona Primary CR and PS Femoral Components
Demonstrated that, for all flexion angles, the contact areas were similar between the CR and PS femoral components.
Anterior Liftoff Testing of the Persona 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 Articular Surfaces
Demonstrated sufficient locking mechanism strength to survive potential worst case shear loading conditions.
Assembly Testing of the Persona Tibia Locking Mechanism
Demonstrated successful assembly of the modular articular surfaces at normal and maximum interference conditions.
Static Shear Strength of the Persona Tibia Locking Mechanism
Demonstrated adequate resistance of the modular articular surfaces to disassembly.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K936159, K070214, K073286, K933785, K960279, K991581, K023211, K060370
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside. Below the circle, the word "zimmer" is written in a serif font.
MAR 2 7 2012
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
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
March 16, 2012
: Zimmer® Persona™ Personalized Knee System
JWH
21 CFR § 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented
Natural Knee II System, manufactured by Zimmer, Inc. (K936159, cleared May 22, 1995)
Gender Solutions™ Natural Knee® Flex System, manufactured by Zimmer, Inc. (K070214, cleared March 16, 2007 and K073286, cleared March 7, 2008)
NextGen Complete Knee System, manufactured by Zimmer, Inc. (K933785, cleared January 30, 1995)
. NexGen Complete Knee Solution Legacy Posterior Stabilized (PS) and Constrained Condylar Knee (CCK), manufactured by Zimmer, Inc. (K960279, cleared April 26, 1996)
NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface Components, manufactured by Zimmer, Inc. (K991581, cleared July 30, 1999)
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K113369
NexGen® Complete Knee Solution Cruciate Retaining Flex Femoral (CR Flex) Components, manufactured by Zimmer, Inc. (K023211, cleared October 17, 2002)
NexGen® Knee Gender Solutions Female (GSF) Femoral Components, manufactured by Zimmer, Inc. (K060370, cleared April 28, 2006)
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 femoral condyle.
- Post-traumatic loss of joint configuration, । particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities. ।
- . I 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.
This device is intended 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:
Device Description:
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
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March 16, 2012
K113369
| Property or
| Characteristic | Test Results |
|---|---|
| Fatigue Test of the Persona Tibia | |
| Keel and Stem Extension | Demonstrated that the Persona tibia keel and stem extension |
| taper junction provide sufficient fatigue strength to survive | |
| expected worst case loading conditions. | |
| Cantilever Fatigue Test of the | |
| Persona Cemented Tibia | Demonstrated adequate fatigue strength in the cantilever |
| loading condition. | |
| Wear Testing of Persona CR | |
| Conventional 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 | |
| Conventional UHMWPE Articular | |
| Surfaces Under Load and Motion | |
| Curves from the ISO 14243 | |
| Standard | Demonstrated that the wear characteristics of the Persona PS |
| articular surfaces, when articulated against the Persona PS | |
| femoral component, are sufficient to survive expected in vivo | |
| loading conditions. | |
| Wear Testing of Persona UC | |
| Conventional UHMWPE Articular | |
| Surfaces Under Displacement | |
| Control with Load and Motion | |
| Curves from the ISO 14243-1 | |
| Standard | Demonstrated that the wear characteristics of the Persona |
| UC articular surfaces, when articulated against the Persona | |
| CR femoral component, are sufficient to survive expected in | |
| vivo loading conditions. | |
| Spine Fatigue Evaluation of the | |
| Persona PS Conventional | |
| UHMWPE Articular Surfaces | Demonstrated that the spine of the Persona PS articular |
| surfaces has sufficient strength to survive expected in vivo | |
| stress/strain loading conditions. | |
| Tibiofemoral Constraint Evaluation | |
| of the Persona Conventional | |
| UHMWPE Articular Surface | Demonstrated that constraint values for the Persona articular |
| surfaces are comparable to data from similar NexGen | |
| articular surfaces. Therefore, the Persona articular surfaces | |
| provide adequate constraint through the needed tibiofemoral | |
| flexion angles. | |
| Property or | |
| Characteristic | Test Results |
| Lateral Constraint Evaluation of | |
| the Persona Conventional All-Poly | |
| Patellar Component on the Persona | |
| CR and PS Femoral Components | Demonstrated that the lateral subluxation force of the |
| Persona conventional all-poly patellar component on the | |
| Persona CR and PS femoral implants at tibiofemoral flexion | |
| angles 0° to 90° was comparable to control testing on | |
| NexGen predicate devcies. | |
| Tibiofemoral Contact Area and | |
| Contact Pressure Evaluation of the | |
| Persona CR/UC/PS Conventional | |
| Articular Surfaces | Demonstrated that the contact area and contact pressure of |
| the Persona articular surfaces are comparable to data from | |
| previous testing on similar NexGen articular surfaces. | |
| Contact Area and Contact Stress | |
| Evaluation of the Persona | |
| Conventional All-Poly Patellar | |
| Component on the Persona | |
| Primary CR and PS Femoral | |
| Components | Demonstrated that, for all flexion angles, the contact areas |
| were similar between the CR and PS femoral components. | |
| Anterior Liftoff Testing of the | |
| Persona 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 Articular Surfaces | Demonstrated sufficient locking mechanism strength to |
| survive potential worst case shear loading conditions. | |
| Assembly Testing of the Persona | |
| Tibia Locking Mechanism | Demonstrated successful assembly of the modular articular |
| surfaces at normal and maximum interference conditions. | |
| Static Shear Strength of the Persona | |
| Tibia Locking Mechanism | Demonstrated adequate resistance of the modular articular |
| surfaces to disassembly. |
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March 16, 2012
K113369
.
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・ :
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Inc. % Ms. Kelli J. Anderson Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
MAR 2 7 2012
Re: K113369
Trade/Device Name: Zimmer™ Persona® Personalized Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Regulatory Class: II Product Codes: JWH Dated: March 16, 2012 Received: March 19, 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
5
Page 2 - Ms. Kelli J. Anderson
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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
P
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and . Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): Jaknown
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. ー
- 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 patellectorny.
- 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.
This device is intended 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)
Dullel
(Dision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113364
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