(133 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.
This device is intended for cemented use only.
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 document describes the non-clinical performance testing for the Zimmer® Persona™ Personalized Knee System, a semi-constrained modular knee prosthesis. Since this is a medical device (knee implant) rather than an AI/software device, many of the requested fields (multi-reader multi-case study, ground truth establishment, training set details) are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implicitly demonstrating "sufficient" or "adequate" strength/wear/constraint, or being "comparable" to predicate devices. The "Test Results" column describes how the device performance met these implicit criteria.
| Property or Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Fatigue Test of the Persona Tibia Keel and Stem Extension | Sufficient fatigue strength to survive expected worst-case loading conditions. | 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 | Adequate fatigue strength in the cantilever loading condition. | 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 | Sufficient wear characteristics to survive expected in-vivo loading conditions. | 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 | Sufficient wear characteristics to survive expected in-vivo loading conditions. | 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 | Sufficient wear characteristics to survive expected in-vivo loading conditions. | 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 | Sufficient strength to survive expected in-vivo stress/strain loading conditions. | 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 | Constraint values comparable to similar NexGen articular surfaces to provide adequate constraint through needed tibiofemoral flexion angles. | 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 | Lateral subluxation force comparable to control testing on NexGen predicate devices. | 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 devices. |
| Tibiofemoral Contact Area and Contact Pressure Evaluation of the Persona CR/UC/PS Conventional Articular Surfaces | Contact area and contact pressure comparable to previous testing on similar NexGen 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 | Contact areas similar between CR and PS femoral components for all flexion angles. | 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 | Sufficient locking mechanism strength to survive potential worst-case anterior liftoff loading conditions during deep flexion. | 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 | Sufficient locking mechanism strength to survive potential worst-case shear loading conditions. | Demonstrated sufficient locking mechanism strength to survive potential worst-case shear loading conditions. |
| Assembly Testing of the Persona Tibia Locking Mechanism | Successful assembly of the modular articular surfaces at normal and maximum interference conditions. | Demonstrated successful assembly of the modular articular surfaces at normal and maximum interference conditions. |
| Static Shear Strength of the Persona Tibia Locking Mechanism | Adequate resistance of the modular articular surfaces to disassembly. | Demonstrated adequate resistance of the modular articular surfaces to disassembly. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for each mechanical test. These "tests" are non-clinical (laboratory-based mechanical and wear simulations) rather than using patient data. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) is not applicable here as these are not studies involving human subjects or patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a medical device, not an AI/software device that requires expert ground truth for its performance evaluation. The "ground truth" for these tests is based on established engineering principles, industry standards (e.g., ISO 14243), and comparison to predicate devices, not expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is non-clinical mechanical testing, not a clinical study requiring human adjudication.
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 is a physical medical device (knee implant), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. As this is not an AI/software device, the concept of a "standalone algorithm" is not relevant. The device itself (the knee implant) is the "standalone" item being tested in these non-clinical performance studies.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance tests is based on:
- Industry Standards: For instance, wear testing was conducted "Under Load and Motion Curves From the ISO 14243 Standard."
- Established Engineering Principles: Tests like fatigue, static shear strength, and contact mechanics rely on well-known engineering material and biomechanical principles.
- Predicate Device Performance: Many tests established comparability to existing, legally marketed predicate devices (e.g., NexGen articular surfaces, NexGen predicate devices). The performance of these predicate devices, which have a history of safe and effective use, serves as a benchmark or "ground truth" for acceptable performance.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device (knee implant), not a machine learning or AI algorithm. There is no concept of a "training set" for the device itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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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Page 4
March 16, 2012
K113369
| Property orCharacteristic | Test Results |
|---|---|
| Fatigue Test of the Persona TibiaKeel and Stem Extension | Demonstrated that the Persona tibia keel and stem extensiontaper junction provide sufficient fatigue strength to surviveexpected worst case loading conditions. |
| Cantilever Fatigue Test of thePersona Cemented Tibia | Demonstrated adequate fatigue strength in the cantileverloading condition. |
| Wear Testing of Persona CRConventional Articular SurfacesUnder Load and Motion CurvesFrom the ISO 14243 Standard | 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 PSConventional UHMWPE ArticularSurfaces Under Load and MotionCurves from the ISO 14243Standard | Demonstrated that the wear characteristics of the Persona PSarticular surfaces, when articulated against the Persona PSfemoral component, are sufficient to survive expected in vivoloading conditions. |
| Wear Testing of Persona UCConventional UHMWPE ArticularSurfaces Under DisplacementControl with Load and MotionCurves from the ISO 14243-1Standard | Demonstrated that the wear characteristics of the PersonaUC articular surfaces, when articulated against the PersonaCR femoral component, are sufficient to survive expected invivo loading conditions. |
| Spine Fatigue Evaluation of thePersona PS ConventionalUHMWPE Articular Surfaces | Demonstrated that the spine of the Persona PS articularsurfaces has sufficient strength to survive expected in vivostress/strain loading conditions. |
| Tibiofemoral Constraint Evaluationof the Persona ConventionalUHMWPE Articular Surface | Demonstrated that constraint values for the Persona articularsurfaces are comparable to data from similar NexGenarticular surfaces. Therefore, the Persona articular surfacesprovide adequate constraint through the needed tibiofemoralflexion angles. |
| Property orCharacteristic | Test Results |
| Lateral Constraint Evaluation ofthe Persona Conventional All-PolyPatellar Component on the PersonaCR and PS Femoral Components | Demonstrated that the lateral subluxation force of thePersona conventional all-poly patellar component on thePersona CR and PS femoral implants at tibiofemoral flexionangles 0° to 90° was comparable to control testing onNexGen predicate devcies. |
| Tibiofemoral Contact Area andContact Pressure Evaluation of thePersona CR/UC/PS ConventionalArticular Surfaces | Demonstrated that the contact area and contact pressure ofthe Persona articular surfaces are comparable to data fromprevious testing on similar NexGen articular surfaces. |
| Contact Area and Contact StressEvaluation of the PersonaConventional All-Poly PatellarComponent on the PersonaPrimary CR and PS FemoralComponents | Demonstrated that, for all flexion angles, the contact areaswere similar between the CR and PS femoral components. |
| Anterior Liftoff Testing of thePersona Articular Surfaces | Demonstrated sufficient locking mechanism strength tosurvive potential worst case anterior liftoff loadingconditions during deep flexion. |
| Posterior Liftoff Fatigue Strength ofthe Persona Articular Surfaces | Demonstrated sufficient locking mechanism strength tosurvive potential worst case shear loading conditions. |
| Assembly Testing of the PersonaTibia Locking Mechanism | Demonstrated successful assembly of the modular articularsurfaces at normal and maximum interference conditions. |
| Static Shear Strength of the PersonaTibia Locking Mechanism | Demonstrated adequate resistance of the modular articularsurfaces to disassembly. |
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March 16, 2012
K113369
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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
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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
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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
Page 1 of 1
ા ર
§ 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.