(56 days)
Not Found
No
The summary describes a mechanical knee prosthesis and its materials, with no mention of AI or ML in its design, function, or testing.
Yes
The device is a knee prosthesis intended to resurface bone in patients with severe knee pain and disability due to various conditions, which directly addresses disease or injury.
No
The device is a knee prosthesis designed to resurface bones, treating severe knee pain and disability. It is an implantable medical device used for treatment, not for diagnosis.
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" and mentions components made from Titanium alloy. This indicates a physical implant, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as a knee prosthesis for treating severe knee pain and disability due to various conditions. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is described as a "semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The performance studies focus on mechanical properties and wear, not diagnostic accuracy.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When a mechanical alignment approach is utilized, 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.
When a kinematic alignment approach is utilized, 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.
- Moderate valgus, varus, or flexion deformities.
The kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.
Porous coated components may be used cemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
Product codes
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. With this submission, femoral components made from Titanium alloy (ASTM F136) that undergo the Ti-Nidium nitriding surface hardening treatment are being added to the system. These femoral components articulate against tibial and patellar articular surfaces to form a total knee system. This design is available in multiple sizing options to accommodate a wide range of anatomies. "Narrow" femoral components have a smaller M/L dimension than the "Standard" femoral components. This femoral component, when used with a PS articular surface component, can accommodate a maximum active flexion of 155°, and when used with a Constrained Posterior Stabilized (CPS) articular surface, can accommodate a maximum active flexion of 135°. These femoral components are provided sterile and single use.
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 Tests:
- Intercondylar (IC) notch deformation testing per an internal test method.
- Posterior condyle fatigue testing per an internal test method.
- Wear Testing of Persona Ti-Nidium Posterior Stabilized (PS) Femoral Components Articulating Against Vivacit-E Articular Surfaces.
- Assessment of wear due to 3rd body particles during articulation.
- Evaluation of the Wear Performance of the Persona Ti-Nidium Posterior Stabilized (PS) Femoral Component Articulating Against Constrained Posterior Stabilized (CPS) Vivacit-E Articular Surfaces.
- Evaluation of the Persona Ti-Nidium Femur Components in the Magnetic Resonance Imaging (MRI) Environment.
- Bacterial Endotoxin Test (BET) per ANSI/AAMI ST 72:2011 as part of cleaning validation demonstrating implants meet the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter Medical Devices - Bacterial Endotoxin and Pyrogen Tests.
Clinical Tests:
- Clinical data was not deemed necessary for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 24, 2020
Zimmer, Inc. Gregory Foster Regulatory Affairs Specialist 1800 W. Center Street Warsaw, Indiana 46580
Re: K200209
Trade/Device Name: Persona® Personalized Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Codes: JWH, OIY Dated: January 27, 2020 Received: January 28, 2020
Dear Gregory Foster:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Ting Song, Ph.D., R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K200209
Device Name
Persona® Personalized Knee System
Indications for Use (Describe)
When a mechanical alignment approach is utilized, 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.
When a kinematic alignment approach is utilized, 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.
- Moderate valgus, varus, or flexion deformities.
The kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.
Porous coated components may be used cemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Persona® Personalized Knee System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708
Establishment Registration Number: 1822565 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gregory Foster
Specialist, Regulatory Affairs
Telephone: 574-371-0519
Fax: 574-372-4710 |
| Date: | 27-Jan-2020 |
| Subject Device: | Trade Name: Persona® Personalized Knee System
Common Name: Knee Prosthesis |
| | Classification Name: |
| | JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560)OIY - Prosthesis, Knee, Patellofemorotibial SemiConstrained, Cemented, Polymer +Additive/Metal/Polymer + Additive (21 CFR 888.3560) |
| Predicate Device(s): | |
| | K113369 Zimmer® Persona™ Knee System Zimmer, Inc. |
| | K062768 NexGen® Complete Knee Solution Legacy® Posterior Stabilized Flex Fixed Bearing and Tivanium® Ti-6Al-4V Alloy Femoral Zimmer, Inc. |
4
Purpose and Device Description:
The purpose of this submission is for the addition of the Ti-Nidium Posterior Stabilized (PS) femoral components to the Persona Personalized Knee System. These modifications do not change the intended use or fundamental scientific technology of the device.
The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. With this submission, femoral components made from Titanium alloy (ASTM F136) that undergo the Ti-Nidium nitriding surface hardening treatment are being added to the system. These femoral components articulate against tibial and patellar articular surfaces to form a total knee system. This design is available in multiple sizing options to accommodate a wide range of anatomies. "Narrow" femoral components have a smaller M/L dimension than the "Standard" femoral components. This femoral component, when used with a PS articular surface component, can accommodate a maximum active flexion of 155°, and when used with a Constrained Posterior Stabilized (CPS) articular surface, can accommodate a maximum active flexion of 135°. These femoral components are provided sterile and single use.
Intended Use and Indications for Use:
When a mechanical alignment approach is utilized, 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.
5
When a kinematic alignment approach is utilized, 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.
-
Moderate valgus, varus, or flexion deformities.
The kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.
Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to predicates. ●
- Indications for Use: Identical to predicate.
- Materials: Similar to predicates. ●
- Design Features: Identical to predicate
- o Sterilization: Identical to predicate.
Summary of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests: 0
- Intercondylar (IC) notch deformation testing per O an internal test method.
- Posterior condyle fatigue testing per an internal o test method.
- Wear Testing of Persona Ti-Nidium Posterior O Stabilized (PS) Femoral Components Articulating Against Vivacit-E Articular Surfaces.
- Assessment of wear due to 3rd body particles o during articulation.
6
- Evaluation of the Wear Performance of the o Persona Ti-Nidium Posterior Stabilized (PS) Femoral Component Articulating Against Constrained Posterior Stabilized (CPS) Vivacit-E Articular Surfaces.
- Evaluation of the Persona Ti-Nidium Femur O Components in the Magnetic Resonance Imaging (MRI) Environment.
- Bacterial Endotoxin Test (BET) per ANSI/AAMI o ST 72:2011 as part of cleaning validation demonstrating implants meet the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter Medical Devices - Bacterial Endotoxin and Pyrogen Tests.
- Clinical Tests: 0
- Clinical data was not deemed necessary for the o subject device.
Substantial Equivalence Conclusion
The subject device has the same intended use and indications for use as the predicate devices. The subject device has similar technological characteristics to the predicates, and the performance data and analyses demonstrate that:
- any differences do not raise new questions of safety . and effectiveness: and
- the proposed device is at least as safe and effective as . the legally marketed predicate devices.