(87 days)
No
The summary describes a mechanical knee prosthesis and its materials, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is a knee joint prosthesis intended to treat severe knee pain and disability caused by various conditions, which are therapeutic aims.
No
Explanation: The device is a knee prosthesis designed for surgical implantation to resurface articulating surfaces, which is a treatment, not a diagnostic, function.
No
The device description clearly states it is a "semi-constrained modular knee prosthesis" and describes physical components made of Titanium alloy. This indicates a hardware medical device, not software only.
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 intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a knee prosthesis designed to resurface bones in the knee joint. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Performance Studies: The performance studies focus on biocompatibility, wear testing, and MRI compatibility, which are relevant to the safety and function of a surgical implant, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
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 (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.
Product codes
JWH, MBH, OIY
Device Description
The Persona Personalized Knee System is a semi-constrained 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 F136-13) with a Titanium Nitride surface treatment are being added to the system (5050, 5056, 5070, 5076 femoral component families). These femoral components articulate against tibial and patellar articular surfaces to form a total knee system. They are available in Cruciate Retaining (CR) and Posterior Stabilized (PS) designs. Both designs are 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. The PS and CR femoral components, when used with a PS or CR articular surface component, can accommodate a maximum active flexion of 155°. The CR femoral component, when used with an Ultra-Congruent (UC) articular surface, can accommodate a maximum active flexion of 145°. The PS femoral component, 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 to the healthcare facility/hospital.
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
healthcare facility/hospital
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
Clinical Performance and Conclusions: Clinical Data and conclusions were not needed for this device.
Non-Clinical Performance and Conclusions: Performance testing and analyses were conducted on the proposed device per FDA's Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses and Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, as well as the standards identified in the test descriptions below.
Test: Biocompatibility testing of Ti-6Al-4V allov with bonded Titanium Nitride.
Results: This test demonstrated that the material utilized by the subject femoral components meet ISO 10993-1 requirements. Therefore, there are no biocompatibility concerns.
Test: Wear testing of the subject femoral components with Persona articular surfaces.
Results: This test, completed per ISO 14243-3, demonstrated that the wear characteristics of the subject femoral components with Persona articular surfaces are equivalent to the predicate device Persona system.
Test: Evaluation of Interactions with the Magnetic Fields in the Magnetic Resonance Imaging (MRI) Environment
Results: This analysis demonstrated safety and compatibility of the Persona knee system within the MRI environment. Therefore, the Persona system can be used under the same MRI conditions previously defined for the predicate device system.
Key Metrics
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2014
Zimmer, Incorporated Mr. Dan Williman Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
Re: K142787 Trade/Device Name: Zimmer® Persona® Personalized Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OIY Dated: September 25, 2014 Received: September 26, 2014
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, 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 requirements, including, but not limited to: registration and listing (21 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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142787
Device Name
Zimmer® Persona® Personalized 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 coated components may be used cemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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574 267-6131
510(k) Summary
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daniel J. Williman
Project Manager, Regulatory Affairs
Telephone: 574-371-8065
Fax: 574-372-4605 |
| Date: | September 25, 2014 |
| Trade Name: | Zimmer® Persona® The Personalized Knee System |
| Product Codes / Device: | MBH, OIY, JWH |
| Regulation / Description: | 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 |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Persona™ Personalized Knee System (K113369, cleared
March 27, 2012)
NexGen Complete Knee Solution Legacy Posterior
Stabilized (LPS)-Flex Fixed Bearing Tivanium Ti-6Al-4V
Alloy Femoral Components, manufactured by Zimmer,
Inc. (K062768, cleared October 13, 2006)
Legion Primary Knee System, manufactured by Smith &
Nephew, Inc., (K093746, cleared April 14, 2010) |
| Purpose and Device
Description: | The Persona Personalized Knee System is a semi-
constrained modular knee prosthesis designed to resurface
the articulating surface of the femoral, tibial and patellar
bones. With this submission, femoral components made |
4
from Titanium alloy (ASTM F136-13) with a Titanium Nitride surface treatment are being added to the system (5050, 5056, 5070, 5076 femoral component families). These femoral components articulate against tibial and patellar articular surfaces to form a total knee system. They are available in Cruciate Retaining (CR) and Posterior Stabilized (PS) designs. Both designs are 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. The PS and CR femoral components, when used with a PS or CR articular surface component, can accommodate a maximum active flexion of 155°. The CR femoral component, when used with an Ultra-Congruent (UC) articular surface, can accommodate a maximum active flexion of 145°. The PS femoral component, 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 to the healthcare facility/hospital.
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.
Intended Use:
5
| Comparison to Predicate Device: | The proposed Persona Personalized Knee System femoral
components are similar or identical in intended use,
materials, sterility, and performance characteristics to the
predicate devices. Testing described below was completed
to demonstrate equivalence to the predicate devices. |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data (Nonclinical
and/or Clinical): | Clinical Performance and Conclusions: |
| | Clinical Data and conclusions were not needed for this
device. |
| | Non-Clinical Performance and Conclusions: |
| | Performance testing and analyses were conducted on the
proposed device per FDA's Class II Special Controls
Guidance Document: Knee Joint Patellofemorotibial and
Femorotibial Metal/Polymer Porous-Coated Uncemented
Prostheses and Establishing Safety and Compatibility of
Passive Implants in the Magnetic Resonance (MR)
Environment, as well as the standards identified in the test
descriptions below. |
| Test | Results |
|---|---|
| Biocompatibility testing of Ti-6Al- | |
| 4V allov with bonded Titanium | This test demonstrated that the material utilized by the |
| subject femoral components meet ISO 10993-1 requirements. | |
| Nitride. | Therefore, there are no biocompatibility concerns. |
| Wear testing of the subject femoral | |
| components with Persona articular | |
| surfaces. | This test, completed per ISO 14243-3, demonstrated that the |
| wear characteristics of the subject femoral components with | |
| Persona articular surfaces are equivalent to the predicate | |
| device Persona system. | |
| Evaluation of Interactions with the | This analysis demonstrated safety and compatibility of the |
| Magnetic Fields in the Magnetic | Persona knee system within the MRI environment. Therefore, |
| Resonance Imaging (MRI) | the Persona system can be used under the same MRI |
| Environment | conditions previously defined for the predicate device |
| system. |