(93 days)
No
The document describes a mechanical knee prosthesis and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies listed are mechanical and material evaluations.
Yes
The device is a knee prosthesis designed to resurface bones and is indicated for patients with severe knee pain and disability due to various conditions, which aligns with the definition of a therapeutic device aimed at treating or alleviating medical conditions.
No
Explanation: The device is described as a "semiconstrained modular knee prosthesis designed to resurface of the femoral and tibial bones," which is a surgical implant, not a diagnostic tool. Its intended use is to treat existing conditions like severe knee pain due to various forms of arthritis and post-traumatic loss of joint configuration, rather than to identify or diagnose these conditions.
No
The device description explicitly states it is a "semiconstrained modular knee prosthesis designed to resurface of the femoral and tibial bones" and describes physical components made of Ti-6Al-4V. The performance studies also focus on the mechanical properties and wear of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating severe knee pain and disability due to various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a modular knee prosthesis designed to resurface bones. This is consistent with a surgical implant.
- Performance Studies: The performance studies listed are related to the mechanical properties, wear, and in-vivo heating of the implant. These are typical tests for a medical device intended for implantation, not for an IVD which would involve testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing diagnostic information.
Therefore, this device falls under the category of a medical device (specifically, a surgical implant), 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 components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.
Porous components may be used cemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and tibial augment components are indicated for cemented use only.
Product codes
JWH, MBH, OIY
Device Description
The purpose of this submission is to add a new component to the Persona Revision Knee System, the component is the Persona Revision SoluTion Femoral Components. The addition of these components do not change the intended use or fundamental scientific technology of the device system.
The Persona Revision Knee System is a semiconstrained modular knee prosthesis designed to resurface of the femoral and tibial bones. With this submission a new Ti-6Al-4V femoral component will be added to the system. These femoral components articulate against an articular surface of the tibial component, as well as, a pat of a total knee system. The new femoral components are compatible with a variety of augments, cones, and stem extent of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These 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 and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Anterior Flange Fatigue Evaluation of the Persona Revision SoluTion Femoral Components.
Posterior Condyle Fatigue Evaluation of the Persona Revision SoluTion Femoral Components.
In Vitro Wear Evaluation of the Persona SoluTion Revision Femoral Components Coupled with Persona Revision Vivacit-E and Persona Primary PS and CPS Vivacit-E Bearings.
In Vitro 3BW and Roughened Femoral Evaluation of the Persona Revision SoluTion Femoral Components.
Persona Revision SoluTion Femur Constraint, Range of Motion (ROM), Contact Area, and Contact Stress Assessment.
Persona Revision SoluTion Femur Augment Shear.
Persona SoluTion Revision Femur Augment Torque.
Persona Revision TiNidium (SoluTion) Stem Junction Fatigue
Persona Revision SoluTion Femur Stem Static Axial Pull-Off
Persona Revision SoluTion Femur Stem Static Torque-Off.
Expanded In-Vivo RF-Induced Heating Simulations for the Persona Revision Knee System (which included analysis of magnetically induced displacement force and torque).
Persona Revision SoluTion Femur Fretting Corrosion Assessment.
Clinical Testing Not Applicable
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 6, 2025
Zimmer, Inc. Gregory Foster Regulatory Affairs Principal 1800 W. Center Street Warsaw, Indiana 46580
Re: K243724
Trade/Device Name: Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OIY Dated: December 3, 2024 Received: February 10, 2025
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Lixin Liu -S
Lixin Liu, Ph.D 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
3
Indications for Use
Submission Number (if known)
Device Name
Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)
Indications for Use (Describe)
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 components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment 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)
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K243724 Page 1 of 2
21 CFR 807.92(a)(4)
21 CFR 807.92(a)(5)
| 510(k) #: K243724 | 510(k) Summary | Prepared on: 2025-03-05 | |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Zimmer, Inc. | ||
| Applicant Address | 1800 W. Center Street Warsaw IN 46580 United States | ||
| Applicant Contact Telephone | (574) 371-0519 | ||
| Applicant Contact | Dr. Gregory Foster | ||
| Applicant Contact Email | gregory.foster@zimmerbiomet.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Persona® Revision Knee System (Persona Revision SoluTion™ Femoral | ||
| Components) | |||
| Common Name | Knee Prosthesis | ||
| Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained | ||
| cemented prosthesis | |||
| Regulation Number | 888.3560; 888.3565 | ||
| Product Code(s) | JWH, MBH, OIY | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K181947 | Persona® Revision Knee System | JWH, MBH, | |
| K200209 | Persona® Personalized Knee System | JWH, OIY |
Device Description Summary
The purpose of this submission is to add a new component to the Persona Revision Knee System, the component is the Persona Revision SoluTion Femoral Components. The addition of these components do not change the intended use or fundamental scientific technology of the device system.
The Persona Revision Knee System is a semiconstrained modular knee prosthesis designed to resurface of the femoral and tibial bones. With this submission a new Ti-6Al-4V femoral component will be added to the system. These femoral components articulate against an articular surface of the tibial component, as well as, a pat of a total knee system. The new femoral components are compatible with a variety of augments, cones, and stem extent of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.
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 patellectorny.
5
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
- 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 components may be used cemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and tibial augment components are indicated for cemented use only.
Indications for Use Comparison
The Indications for Use are Identical between the Subject and Predicate devices.
Technological Comparison
The subject and predicate devices are both femoral components. The articulating geometry are equivalent between the predicate and the subject devices. The difference is that the predicate is manufactured with Co-Cr-Mo alloy, while the subject device is manufactured with forged Ti-6Al-4V and undergoes the Ti-Nidium™ nitrogen surfacing hardening process.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Anterior Flange Fatigue Evaluation of the Persona Revision SoluTion Femoral Components.
Posterior Condyle Fatigue Evaluation of the Persona Revision SoluTion Femoral Components.
In Vitro Wear Evaluation of the Persona SoluTion Revision Femoral Components Coupled with Persona Revision Vivacit-E and Persona Primary PS and CPS Vivacit-E Bearings.
In Vitro 3BW and Roughened Femoral Evaluation of the Persona Revision SoluTion Femoral Components.
Persona Revision SoluTion Femur Constraint, Range of Motion (ROM), Contact Area, and Contact Stress Assessment.
Persona Revision SoluTion Femur Augment Shear.
Persona SoluTion Revision Femur Augment Torque.
Persona Revision TiNidium (SoluTion) Stem Junction Fatigue
Persona Revision SoluTion Femur Stem Static Axial Pull-Off
Persona Revision SoluTion Femur Stem Static Torque-Off.
Expanded In-Vivo RF-Induced Heating Simulations for the Persona Revision Knee System (which included analysis of magnetically induced displacement force and torque).
Persona Revision SoluTion Femur Fretting Corrosion Assessment.
Clinical Testing Not Applicable
The proposed device has the same intended use as the proposed device has similar technological characteristics to the predicate(s), and the information provided herein demonstrates that:
· any differences do not raise different questions of safety and effectiveness; and
· the proposed device is at least as safe and effective as the legally marketed predicate device(s).