(105 days)
No
The summary describes a mechanical knee prosthesis and bench testing of its physical properties, with no mention of AI or ML.
Yes.
The device is a knee prosthesis designed to resurface articulating surfaces, indicated for patients with severe knee pain and disability due to various conditions like arthritis, collagen disorders, and avascular necrosis. Its function is to address and alleviate symptoms of these medical conditions directly, which is the definition of a therapeutic device.
No
This device is a knee prosthesis, which is an implant used to replace the articular surfaces of the knee joint. It is a treatment device, not a diagnostic one.
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," indicating it is a physical implant, not software. The performance studies also focus on physical properties and interactions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description: The provided description clearly states that the Zimmer Persona Personalized Knee System is a "semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones." This is a surgically implanted device used to replace damaged parts of the knee joint.
- Intended Use: The intended use describes the conditions for which the device is indicated, all of which relate to severe knee pain and disability requiring surgical intervention and joint replacement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids, or providing diagnostic information based on laboratory analysis.
This device is a surgical implant used for joint replacement, 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.
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.
Product codes
MBH, OIY, JWH
Device Description
The Zimmer 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 Constrained Posterior Stabilized (CPS) Vivacit-E® articular surface components will provide surgeons with the ability to obtain moderate varus/valgus and/or internal/external rotation constraint compared to the existing Persona PS articular surfaces. CPS articular surfaces are for use with cemented nonporous tibial and femoral components only.
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)
Bench testing was conducted:
- Anterior Tibiofemoral Constraint Evaluation of the Persona CPS Vivacit-E UHMWPE Articular Surfaces with the Lowest Anterior Jump Height: Demonstrated that the Persona CPS Vivacit-E articular surfaces provide adequate anterior subluxation constraint through the necessary tibiofemoral flexion movements.
- Anterior and Posterior Liftoff Testing of the Persona CPS Vivacit-E UHMWPE Articular Surfaces: Demonstrated sufficient locking mechanism strength to survive potential worst case anterior and posterior liftoff loading conditions, respectively.
- Evaluation of Interactions of the Zimmer Persona Primary and Persona Porous Knee Implant Systems with the Magnetic Fields in the Magnetic Resonance Imaging (MRI) Environment: Demonstrated safety and compatibility of the Persona knee system within the MRI environment.
- Spine Fatigue and Underspine Fatigue Evaluation of the Persona CPS Vivacit-E UHMWPE Articular Surfaces: Demonstrated sufficient resistance to spine fracture, underspine fracture, and locking mechanism dissociation during worst case walking gait conditions.
- Spine Fatigue Evaluation of the Persona CPS Vivacit-E Articular Surfaces: Demonstrated that the spine of the Persona Vivacit-E CPS articular surfaces has sufficient strength to survive expected in-vivo loading conditions.
- Spine Fracture and Locking Mechanism Resistance of Persona CPS Vivacit-E UHMWPE During Varus/Valgus Loading: Demonstrated sufficient locking mechanism and articular surface spine strength to withstand worst case varus or valgus loading conditions.
- Tibiofemoral Constraint Evaluation of the Persona CPS Vivacit-E UHMWPE: Determined the anterior-posterior, medial-lateral, internal-external and varus-valgus constraint of the Persona CPS Vivacit-E articular surfaces through the necessary tibiofemoral flexion movements.
- Tibiofemoral Contact Area and Contact Pressure Evaluation of the Persona CPS Vivacit-E UHMWPE Articular Surfaces: Determined the contact area and contact pressure of the Persona CPS Vivacit-E articular surfaces through the necessary tibiofemoral flexion movements.
- Wear Testing of Persona CPS Vivacit-E UHMWPE Articular Surfaces: Demonstrated that the wear characteristics of the Persona CPS Vivacit-E articular surfaces, when articulated against the Persona PS femoral component, are sufficient to survive expected in vivo loading conditions.
- EO Residual Testing of Persona CPS Vivacit-E UHMWPE Articular Surfaces: Demonstrated acceptable residual levels following EO sterilization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PersonaTM Personalized Knee System (K113369, cleared March 27, 2012), Zimmer® Persona™ The Personalized Knee System (K121771, cleared November 7, 2012)
Reference Device(s)
NexGen Complete Knee Solution Legacy Posterior Stabilized (PS) and Constrained Condylar Knee (LCCK). manufactured by Zimmer, Inc. (K960279 cleared April 26, 1996), NexGen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular Surfaces, manufactured by Zimmer, Inc. (K042271, cleared October 13, 2004), Zimmer Vivacit-E Polyethylene Liners (K120370), Persona Vivacit-E articular surfaces (K121771)
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
FEB 2 2 2013
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
Daniel J. Williman Project Manager, Regulatory Affairs Telephone: (574) 371-8065 Fax: (574) 372-4605
January 25, 2013
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 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
PersonaTM Personalized Knee System (K113369, cleared March 27, 2012)
Zimmer® Persona™ The Personalized Knee System (K121771, cleared November 7, 2012)
NexGen Complete Knee Solution Legacy Posterior Stabilized (PS) and Constrained Condylar Knee (LCCK). manufactured by Zimmer, Inc. (K960279 cleared April 26, 1996)
NexGen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular Surfaces, manufactured by Zimmer, Inc. (K042271, cleared October 13, 2004)
1
Device Description:
The Zimmer 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 Constrained Posterior Stabilized (CPS) Vivacit-E® articular surface components will provide surgeons with the ability to obtain moderate varus/valgus and/or internal/external rotation constraint compared to the existing Persona PS articular surfaces. CPS articular surfaces are for use with cemented nonporous tibial and femoral components only.
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polvarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of ioint 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 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:
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
2
Vivacit-E material characteristics for the CPS articular surfaces are identical to the material characteristics of the currently marketed Zimmer Vivacit-E Polyethylene Liners (K120370) and Persona Vivacit-E articular surfaces (K121771). 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 in support of this device:
| Property or Characteristics | Test Results |
|---|---|
| Anterior Tibiofemoral Constraint | |
| Evaluation of the Persona CPS Vivacit-E | |
| UHMWPE Articular Surfaces with the | |
| Lowest Anterior Jump Height | Demonstrated that the Persona CPS Vivacit-E articular |
| surfaces provide adequate anterior subluxation constraint | |
| through the necessary tibiofemoral flexion movements. | |
| Anterior and Posterior Liftoff Testing of the | |
| Persona CPS Vivacit-E UHMWPE Articular | |
| Surfaces | Demonstrated sufficient locking mechanism strength to |
| survive potential worst case anterior and posterior liftoff | |
| loading conditions, respectively. | |
| Evaluation of Interactions of the Zimmer | |
| Persona Primary and Persona Porous Knee | |
| Implant Systems with the Magnetic Fields in | |
| the Magnetic Resonance Imaging (MRI) | |
| Environment | Demonstrated safety and compatibility of the Persona |
| knee system within the MRI environment. | |
| Spine Fatigue and Underspine Fatigue | |
| Evaluation of the Persona CPS Vivacit-E | |
| UHMWPE Articular Surfaces | Demonstrated sufficient resistance to spine fracture, |
| underspine fracture, and locking mechanism dissociation | |
| during worst case walking gait conditions. | |
| Spine Fatigue Evaluation of the Persona | |
| CPS Vivacit-E Articular Surfaces | Demonstrated that the spine of the Persona Vivacit-E CPS |
| articular surfaces has sufficient strength to survive | |
| expected in-vivo loading conditions. | |
| Spine Fracture and Locking Mechanism | |
| Resistance of Persona CPS Vivacit-E | |
| UHMWPE During Varus/Valgus Loading | Demonstrated sufficient locking mechanism and articular |
| surface spine strength to withstand worst case varus or | |
| valgus loading conditions. | |
| Tibiofemoral Constraint Evaluation of the | |
| Persona CPS Vivacit-E UHMWPE | Determined the anterior-posterior, medial-lateral, internal- |
| external and varus-valgus constraint of the Persona CPS | |
| Vivacit-E articular surfaces through the necessary | |
| tibiofemoral flexion movements. |
3
.
.
.
| Property or Characteristics | Test Results |
|---|---|
| Tibiofemoral Contact Area and Contact | |
| Pressure Evaluation of the Persona CPS | |
| Vivacit-E UHMWPE Articular Surfaces | Determined the contact area and contact pressure of the |
| Persona CPS Vivacit-E articular surfaces through the | |
| necessary tibiofemoral flexion movements. | |
| Wear Testing of Persona CPS Vivacit-E | |
| UHMWPE Articular Surfaces | Demonstrated that the wear characteristics of the Persona |
| CPS Vivacit-E articular surfaces, when articulated against | |
| the Persona PS femoral component, are sufficient to | |
| survive expected in vivo loading conditions. | |
| EO Residual Testing of Persona CPS | |
| Vivacit-E UHMWPE Articular Surfaces | Demonstrated acceptable residual levels following EO |
| sterilization. |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines extending from its head, resembling feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 22, 2013
Zimmer, Incorporated % Mr. Daniel Williman Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K123459
Trade/Device Name: Zimmer® 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: January 25, 2013 Received: January 28, 2013
Dear Mr. Williman:
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. Iisting 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 - Mr. Daniel J. Williman
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 vours.
Image /page/5/Picture/7 description: The image shows the name "Erin Keith" in a stylized font. The letters "I", "L", and "K" are decorated with geometric patterns. The rest of the letters are in a plain, bold font. The name appears to be a logo or a design element.
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): K123459
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.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities. ー
- The salvage of previously failed surgical attempts or for a knee in which satisfactory l 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
3.02.21 14:58:17
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
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