(124 days)
Not Found
No
The summary describes a mechanical knee prosthesis and its material properties and performance testing, with no mention of AI or ML.
Yes
The device is described as a "semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones," and its "Intended Use" clearly states its purpose in treating severe knee pain and disability due to various medical conditions, indicating a therapeutic function.
No
This device is a knee prosthesis, which is a therapeutic device designed to replace or resurface parts of the knee joint. It is not used for diagnosing medical conditions.
No
The device description clearly states it is a "semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones," which are physical components, not software. The performance studies also focus on physical properties like wear, constraint, contact area, and interaction with MRI.
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 for treating severe knee pain and disability through surgical implantation. 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. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Performance Studies: The performance studies focus on mechanical properties, wear, constraint, contact area, and MRI compatibility of the implant. These are relevant to the safety and effectiveness of a surgical implant, not the analytical or clinical performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a medical device (specifically, a surgical implant) but 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MBH, OIY, JWH
Device Description
The Zimmer Persona Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces. With this submission, Medial Congruent (MC) Vivacit-E® articular surface components are being added to the system. The subject components articulate against, the existing Cruciate Retaining (CR) femoral component, and lock onto the existing tibial baseplate components using a dovetail mechanism. The subject articular surface components, when used with the CR femoral, can accommodate a maximum active flexion of 155°. The MC articular surfaces provide greater medial conformity, similar anterior lateral conformity, and less posterior lateral conformity when compared to the predicate Persona UC articular surface design. In addition, the subject articular surface can be implanted with or without a functioning PCL. The components are single use and are provided sterile to the healthcare facility/hospital. MC articular surfaces are for use with both cemented and uncemented femoral and tibial baseplate components.
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)
Clinical Performance and Conclusion:
Clinical data and conclusions were not needed for this device.
Property or Characteristics: Biocompatibility testing Vivacit-E UHMWPE
Analysis/Test Results: The proposed Persona MC articular surfaces are manufactured from identical material as the predicate device. Therefore, in terms of biocompatibility, the subject devices are substantially equivalent.
Property or Characteristics: Evaluation of the Wear Performance of the Persona Medial Congruent Vivacity-E Articular Surfaces
Analysis/Test Results: This evaluation demonstrated the wear characteristics of the subject articular surfaces are expected to be equivalent to the predicate articular surface.
Property or Characteristics: Tibiofemoral Constraint Evaluation of the Persona Medial Congruent Vivacit-E Articular Surfaces
Analysis/Test Results: Determined the anterior-posterior, medial-lateral, internal-external and varus-valgus constraint of the Persona MC Vivacit-E articular surfaces through the necessary tibiofemoral flexion movements.
Property or Characteristics: Tibiofemoral Contact Area and Contact Pressure Evaluation of the Persona Medial Congruent Vivacit-E Articular Surfaces
Analysis/Test Results: Determined the contact area and contact pressure of the Persona MC Vivacit-E articular surfaces through the necessary tibiofemoral flexion movements.
Property or Characteristics: Anterior and Posterior Liftoff Testing of the Persona MC Vivacit-E UHMWPE Articular Surfaces
Analysis/Test Results: This evaluation demonstrated that the locking mechanism of the subject articular surfaces is equivalent to the predicate articular surfaces.
Property or Characteristics: Evaluation of Interactions with the Magnetic Fields in the Magnetic Resonance Imaging (MRI) Environment
Analysis/Test Results: This evaluation demonstrated that the Persona MC components can be used under the same MRI conditions previously defined for the predicate device system.
Property or Characteristics: Posterior Crush Evaluation for the Persona Medial Congruent articular surface
Analysis/Test Results: This evaluation demonstrated the stress response in the MC articular surfaces when subjected to posterior crush edge loading conditions in deep flexion and in walking gait is equivalent to the predicate articular surfaces.
Non-Clinical Performance and Conclusions: Vivacit-E material characteristics for the MC articular surfaces are identical to the material characteristics of the currently marketed Zimmer Persona Vivacit-E articular surfaces (K121771, predicate device).
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
PersonaTM Personalized Knee System, manufactured by Zimmer, Inc. (K121771, cleared November 7, 2012)
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2015
Zimmer, Incorporated Ms. Andrea Pilon Artman Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
Re: K150090 Trade/Device Name: Zimmer® Persona® Personalized 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, OIY, JWH Dated: April 15, 2015 Received: April 16, 2015
Dear Ms. Artman:
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
Page 2 - Ms. Andrea Pilon Artman
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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
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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510(k) Summary
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Andrea Pilon Artman
Specialist, Regulatory Affairs
Telephone: 574-371-9308
Fax: 574-372-4605 |
| Date: | April 28, 2015 |
| Trade Name: | Zimmer® Persona® 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): | PersonaTM Personalized Knee System, manufactured by
Zimmer, Inc. (K121771, cleared November 7, 2012) |
| Purpose and Device
Description: | The Zimmer Persona Personalized Knee System is a semi-
constrained modular knee prosthesis designed to resurface
the articulating surface of the femoral, tibial and patellar
bones. The Persona Knee System utilizes a modular
design between the tibial plates and articular surfaces. With
this submission, Medial Congruent (MC) Vivacit-E®
articular surface components are being added to the system.
The subject components articulate against, the existing
Cruciate Retaining (CR) femoral component, and lock onto
the existing tibial baseplate components using a dovetail
mechanism. The subject articular surface components,
when used with the CR femoral, can accommodate a
maximum active flexion of 155°. The MC articular |
| | surfaces provide greater medial conformity, similar anterior lateral conformity, and less posterior lateral conformity when compared to the predicate Persona UC articular surface design. In addition, the subject articular surface can be implanted with or without a functioning PCL. The components are single use and are provided sterile to the healthcare facility/hospital. MC articular surfaces are for use with both cemented and uncemented femoral and tibial baseplate components. |
| Intended 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 or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only. |
| Comparison to Predicate Device: | The proposed Zimmer Persona Personalized Knee System components identical in intended use, materials, sterility, and are identical or similar in 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 Conclusion:
Clinical data and conclusions were not needed for this device. |
| Property or Characteristics | Analysis/Test Results |
| Biocompatibility testing Vivacit-E
UHMWPE | The proposed Persona MC articular surfaces are manufactured
from identical material as the predicate device. Therefore, in
terms of biocompatibility, the subject devices are substantially
equivalent. |
| Evaluation of the Wear Performance
of the Persona Medial Congruent
Vivacity-E Articular Surfaces | This evaluation demonstrated the wear characteristics of the
subject articular surfaces are expected to be equivalent to the
predicate articular surface. |
| Tibiofemoral Constraint Evaluation
of the Persona Medial Congruent
Vivacit-E Articular Surfaces | Determined the anterior-posterior, medial-lateral, internal-
external and varus-valgus constraint of the Persona MC Vivacit-E
articular surfaces through the necessary tibiofemoral flexion
movements. |
| Tibiofemoral Contact Area and
Contact Pressure Evaluation of the
Persona Medial Congruent Vivacit-E
Articular Surfaces | Determined the contact area and contact pressure of the Persona
MC Vivacit-E articular surfaces through the necessary
tibiofemoral flexion movements. |
| Anterior and Posterior Liftoff
Testing of the Persona MC Vivacit-E
UHMWPE Articular Surfaces | This evaluation demonstrated that the locking mechanism of the
subject articular surfaces is equivalent to the predicate articular
surfaces. |
| Evaluation of Interactions with the
Magnetic Fields in the Magnetic
Resonance Imaging (MRI)
Environment | This evaluation demonstrated that the Persona MC components
can be used under the same MRI conditions previously defined
for the predicate device system. |
| Posterior Crush Evaluation for the
Persona Medial Congruent articular
surface | This evaluation demonstrated the stress response in the MC
articular surfaces when subjected to posterior crush edge loading
conditions in deep flexion and in walking gait is equivalent to the
predicate articular surfaces. |
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5
Non-Clinical Performance and Conclusions: Vivacit-E material characteristics for the MC articular surfaces are identical to the material characteristics of the currently marketed Zimmer Persona Vivacit-E articular surfaces (K121771, predicate device).
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.