(60 days)
Not Found
No
The document describes a mechanical implant and its intended use, with performance studies based on Finite Element Analysis (FEA), which is a simulation technique, not AI/ML. There are no mentions of AI, ML, or related concepts.
Yes
The device is indicated for alleviating severe knee pain and disability associated with various medical conditions, and it is used in surgical procedures to improve joint configuration and stability. These functions indicate a therapeutic purpose.
No
Explanation: The device is a Persona Revision Knee System intended to fill distal femoral cavitary bone defects during knee arthroplasty, and its intended use description focuses on treating conditions like severe knee pain and disability, not on diagnosing them.
No
The device description clearly states it is a "Persona Revision Knee System femoral metaphyseal cones," which are physical implants used in knee arthroplasty. The submission is for changes to these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for surgical implantation to treat severe knee pain and disability. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor conditions.
- Device Description: The device is described as a "Persona Revision Knee System femoral metaphyseal cone," which is a physical implant used in knee surgery.
- Anatomical Site: The anatomical site is the "Femoral condyle, knee," indicating a part of the human body where the device is implanted.
- Performance Studies: The performance study mentioned is "Finite Element Analysis (FEA)," which is a method used to analyze the structural integrity of physical objects under stress, not a method for evaluating the performance of a diagnostic test.
All the information points to this being a surgical implant, not a device used for in vitro diagnostic testing.
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.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
Device Description
The purpose of this submission is to obtain clearance for the changes/proposed changes made to the Persona Revision Knee System femoral metaphyseal cones post their original 510(k) submission/clearance. The Persona Revision Knee System femoral metaphyseal cones are intended to fill distal femoral cavitary bone defects during knee arthroplasty.
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)
Finite Element Analysis (FEA) was used to predict the peak stress under physiological loading for the subject Persona Revision Knee System femoral metaphyseal cones.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
May 18, 2021
Image /page/0/Picture/1 description: The image contains 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.
Zimmer, Inc. Romil Sheth Regulatory Affairs Project Manager 1800 W. Center Street Warsaw. Indiana 46580
Re: K210829
Trade/Device Name: Persona® Revision Knee System Femoral Metaphyseal Cones Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: March 16, 2021 Received: March 19, 2021
Dear Romil Sheth:
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,
Ting Song, Ph.D., R.A.C. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210829
Device Name
Persona Revision Knee System Femoral Metaphyseal Cones
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 confi guration, 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 augments 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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510(k) Summary
| Sponsor: | Zimmer, Inc.
1800 W. Center Street
Warsaw, IN 46580
Establishment Registration Number: 1822565 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Romil Sheth
Regulatory Affairs Project Manager
Telephone: (574-268-8196)
Romil.Sheth@zimmerbiomet.com |
| Date: | March 16, 2021 |
| Subject Device: | Trade Name: Persona® Revision Knee System Femoral
Metaphyseal Cones
Classification Name:
• JWH - Prosthesis, Knee, Patellofemorotibial, Semi-
Constrained, Cemented, Polymer/Metal/Polymer (21
CFR 888.3560 – Knee joint Patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis)
• MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-
Constrained, Uncemented, Porous, Coated,
Polymer/Metal/Polymer (21 CFR 888.3565 – Knee
joint Patellofemorotibial metal/polymer porous-coatec
uncemented prosthesis) |
| Predicate Device(s): | K181947 Persona Revision Zimmer, Inc.
Knee System |
| Device Description: | The purpose of this submission is to obtain clearance for
the changes/proposed changes made to the Persona
Revision Knee System femoral metaphyseal cones post
their original 510(k) submission/clearance |
4
The Persona Revision Knee System femoral metaphyseal cones are intended to fill distal femoral cavitary bone defects during knee arthroplasty.
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.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Same as the predicate device. o
- Indications for Use: Same as the predicate device.
- Geometry/Configurations/Sizes: Same as the 0 predicate device.
- Material: Same as the predicate device.
- Bone Interface Finish: Same as the predicate device. ●
- o Fixation Method of Bone: Same as the predicate device.
- o Sterility: Same as the predicate device.
- Design Features: Similar to the predicate device. ●
Summary of Technological Characteristics:
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Summary of Performance Data (Nonclinical and/or Clinical)
Finite Element Analysis (FEA) was used to predict the peak stress under physiological loading for the subject Persona Revision Knee System femoral metaphyseal cones.
Substantial Equivalence Conclusion
Based on the information contained within this submission, it is concluded that the Persona Revision Knee System femoral metaphyseal cones are substantially equivalent to the identified predicate device.