(79 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.
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.
The Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including:
- Femoral components
- Articular surfaces
- Tibial components
- Stem extensions
- Femoral and tibial augments
- Femoral and tibial cones.
The large modularity of the componentry of the Persona Revision knee system including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery.
The Persona Revision Knee System also includes nonimplantable tools, or instrumentation, that facilitate the implantation of above described implant components as well as cases and trays to hold these instruments during sterilization and their subsequent storage.
I'm sorry, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.
The provided text is an FDA 510(k) clearance letter for a Persona Revision Knee System, which is a medical device (a knee prosthesis). This document primarily focuses on the regulatory clearance process, stating that the device is "substantially equivalent" to legally marketed predicate devices.
It does NOT contain information about:
- Specific acceptance criteria metrics (e.g., in terms of sensitivity, specificity, accuracy for an AI/algorithm-based device).
- Detailed performance study results for an AI/algorithm-based device.
- Sample sizes for test sets or training sets in the context of an AI/algorithm.
- Information about expert consensus, ground truth establishment methods, multi-reader multi-case studies, or standalone algorithm performance.
The document mentions "Non-Clinical Tests" and "Clinical Tests" but these refer to mechanical and sterility testing of the knee implant and associated instruments, not to the performance evaluation of an AI or algorithmic medical device. For example, "Stem housing cantilever fatigue" and "Cadaveric design validation" are relevant to a physical medical implant, not a software algorithm. The document explicitly states, "Clinical data was not deemed necessary for the subject device," further indicating that a a large-scale clinical performance study (as would be typical for an AI/ML device) was not conducted or required for this particular type of device clearance.
Therefore, your request, which is structured around the evaluation of an AI or algorithm-based medical device, cannot be answered using the provided text, as the text describes a hardware medical implant, not a software device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.
September 5, 2019
Zimmer Inc. Nicole Meredith Regulatory Project Manager 1800 W. Center Street Warsaw, Indiana 46580
Re: K191625
Trade/Device Name: Persona Revision 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: June 14, 2019 Received: June 18, 2019
Dear Nicole Meredith:
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
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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 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 (QS) 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 medical devices and radiation-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. 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
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Indications for Use
510(k) Number (if known) K191625
Device Name Persona® Revision Knee System
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 (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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K191625 - Page 1 of 4
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 Revision 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.1800 W. Center StreetWarsaw, IN 46580Establishment Registration Number: 1822565 | |
|---|---|---|
| Contact Person: | Nicole J. MeredithRegulatory Affairs Project ManagerTelephone: (574) 377-3718Fax: (574) 372-4710 | |
| Date: | August 19, 2019 | |
| Subject Device: | Trade Name: Persona® Revision Knee System | |
| Common Name: Knee Prosthesis | ||
| Classification Name: | ||
| • | MBH – Prosthesis, Knee, Patello/Femorotibial,Semi-Constrained, Uncemented, Porous, Coated,Polymer/Metal/Polymer (21 CFR 888.3565) | |
| • | JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (2CFR 888.3560) | |
| • | OIY – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer +Additive/Metal/Polymer + Additive (21 CFR888.3560) | |
| Predicate Devices: | Persona Revision Knee System | K181947 |
| Natural-Knee II System | K173057K013031K982903K972501 |
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Purpose and Device Description:
The purpose of this submission is for modifications to the Persona Revision stem extensions, several instruments, and the associated case components of the Persona Revision Knee System. These modifications do not change the intended use or fundamental scientific technology of the device.
The Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including:
- Femoral components
- Articular surfaces ●
- Tibial components
- Stem extensions ●
- Femoral and tibial augments ●
- Femoral and tibial cones .
The large modularity of the componentry of the Persona Revision knee system including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery.
The Persona Revision Knee System also includes nonimplantable tools, or instrumentation, that facilitate the implantation of above described implant components as well as cases and trays to hold these instruments during sterilization and their subsequent storage.
Intended Use and 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. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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- 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.
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to the predicates ●
- Indications for Use: Identical to the predicates ●
- Materials: Identical to the predicates ●
- Design Features: Similar to the predicates ●
- . Sterilization: Identical to the predicates
Summary of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests: . Stem Extensions
- Stem housing cantilever fatigue per internal test o method
- Four-point bending fatigue strength per internal O test method
Instrumentation
- Functional relationship analyses (tolerance stack o up)
- Drill debris analysis per internal test method O
- Reliability verification per internal test method O
- O Cadaveric design validation
Cases and Trays
- Distribution and handling verification per ASTM о D4169
System
- Bacterial Endotoxin Test (BET) per ANSI/AAMI o ST 72:2011as part of cleaning validation
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K191625 - Page 4 of 4
demonstrating implants meet the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter <161> Medical Devices - Bacterial Endotoxin and Pyrogen Tests
Clinical Tests: ●
-
o Clinical data was not deemed necessary for the subject device.
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.
Substantial Equivalence Conclusion
§ 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.