(178 days)
Not Found
No
The summary describes a knee prosthesis and its components, focusing on materials, design, and mechanical testing. There is no mention of AI, ML, image processing, or any computational analysis of patient data for diagnosis, treatment planning, or device operation.
Yes
Explanation: The device is a total knee prosthesis designed to resurface articulating surfaces in patients with severe knee pain and disability due to various conditions like arthritis and avascular necrosis. Its primary purpose is to alleviate symptoms and restore function, which directly aligns with the definition of a therapeutic device.
No
This device is a knee prosthesis, specifically designed to resurface the articulating surfaces of the knee bones in patients with severe knee pain and disability. Its purpose is treatment through surgical implantation, not diagnosis.
No
The device description explicitly states the addition of new physical components (femoral components, tibial plates) and reusable instruments, indicating it is a hardware-based medical device system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly 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 described as a modular knee prosthesis designed to resurface bones. This is a medical device intended for implantation, not for analyzing biological samples.
- 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 condition based on laboratory testing.
- Performance Studies: The performance studies focus on mechanical properties, fatigue strength, fixation, and biocompatibility, which are relevant to implanted medical devices, not IVDs.
In summary, the device is a knee implant used in surgery, which falls under the category of a medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When a mechanical alignment approach is utilized, 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.
When a kinematic alignment approach is utilized, 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.
- · Moderate valgus, varus, or flexion deformities.
The kinematic alignment (KA) surgical technique may only be used with Persona porous and cemented non-porous CR femoral components, Persona CR or UC articular surface components, and the cemented nonporous Persona Natural cemented 5 degree tibial components without a stem extension,
Porous coated components may be used cemented (biological fixation), except for the Persona porous 0 degree OsseoTi Spiked Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and allpolyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH. MBH. OIY
Device Description
The purpose of this submission is to add three new components to the Persona Personalized Knee System. These components consist of a non-porous cemented stemmed tibial baseplate, a porous OsseoTiTM non-cemented tibial baseplate, and a porous plasma sprayed femur. The addition of these components do not change the intended use or fundamental scientific technology of the device system.
The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones. With this submission a new porous plasma sprayed femoral component will be added to the system. These femoral components articulate against tibial and patellar articular surface to form a total knee system. In addition, two new tibial plates will be added, a cemented non-porous stem tibial baseplate and a porous OsseoTiTM stemmed tibial baseplate. All of the new components come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use. To aid the implantation of these devices several new reusable instruments are also introduced.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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 Tests:
- Posterior condyle fatigue testing per internal test methods.
- Anterior flange fatigue testing per an internal test method.
- Evaluation of porous plasma spray (PPS) coating.
- Evaluation of OsseoTi porous structure.
- Fatigue strength of the Persona 0 degree Cemented Keel Tibial Baseplate per ASTM F1800 and ISO 14879-1.
- Fatigue strength of the Persona 0 degree Spiked Keel Tibial Baseplate per ASTM F1800 and ISO 14879-1.
- Evaluation of the level of micromotion of the Persona 0 degree OsseoTi tibial baseplate per an internal test method.
- Fixation performance of the Persona 0 degree Cemented Keel Tibia per an internal test method.
- Analysis of keel and peg drill perforation rate.
- Assessment of MR compatibility.
- Bacterial Endotoxin Test (BET) per ANSI/AAMI ST 72:2011as part of cleaning validation demonstrating implants meet the limit of Medical Devices - Bacterial Endotoxin and Pyrogen Tests.
Clinical Tests: None provided
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.
K113369, K122745, K173417, K113550, K140669, K936159
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
November 17, 2022
Zimmer, Inc. Gregory Foster Senior Regulatory Affairs Specialist 1800 W. Center Street Warsaw, Indiana 46580
Re: K221479
Trade/Device Name: Persona® Personalized Knee System 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: October 17, 2022 Received: October 18, 2022
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 (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
1
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,
Ting Song -S
Ting Song, 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
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Indications for Use
510(k) Number (if known) K221479
Device Name
Zimmer® Persona™ Personalized Knee System
Indications for Use (Describe)
When a mechanical alignment approach is utilized, 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.
When a kinematic alignment approach is utilized, 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.
- · Moderate valgus, varus, or flexion deformities.
The kinematic alignment (KA) surgical technique may only be used with Persona porous and cemented non-porous CR femoral components, Persona CR or UC articular surface components, and the cemented nonporous Persona Natural cemented 5 degree tibial components without a stem extension,
Porous coated components may be used cemented (biological fixation), except for the Persona porous 0 degree OsseoTi Spiked Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and allpolyethylene (UHMWPE and VEHXPE) patella 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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3
510(k) Summary
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708
Establishment Registration Number: 1822565 | | | | | | | | | | | | | | | | | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Contact Person: | Gregory Foster
Sr. Regulatory Specialist
Telephone: (574) 371-0519
Fax: (574) 377-3718
Gregory.foster@zimmerbiomet.com | | | | | | | | | | | | | | | | | | |
| Date: | 14-Nov-2022 | | | | | | | | | | | | | | | | | | |
| Subject Device: | Trade Name: Persona® Personalized Knee System
Common Name: Knee Prosthesis | | | | | | | | | | | | | | | | | | |
| | Classification Name:
• JWH – Knee joint patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis (21 CFR 888.3560)
• MBH - Knee joint patellofemorotibial metal/polymer porous-
coated uncemented prosthesis (21 CFR 888.3565)
• OIY- Knee joint patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis (21 CFR 888.3560) | | | | | | | | | | | | | | | | | | |
| Predicate Device(s): | K113369 Zimmer®
Persona™ Knee
System Zimmer, Inc. K122745 Zimmer®
Persona™ Knee
System Zimmer, Inc. K173417 Zimmer®
Persona™ Knee
System Zimmer, Inc. K113550 Vanguard
Complete Knee
System Biomet, Inc. K140669 G7 OsseoTi™
Acetabular Shells Biomet, Inc. K936159 Natural Knee II
System Zimmer, Inc. | | | | | | | | | | | | | | | | | | |
4
| Device Description: | The purpose of this submission is to add three new components to the
Persona Personalized Knee System. These components consist of a non-
porous cemented stemmed tibial baseplate, a porous OsseoTiTM non-
cemented tibial baseplate, and a porous plasma sprayed femur. The
addition of these components do not change the intended use or
fundamental scientific technology of the device system. |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Persona Personalized Knee System is a semiconstrained modular
knee prosthesis designed to resurface the articulating surface of the
femoral, tibial, and patellar bones. With this submission a new porous
plasma sprayed femoral component will be added to the system. These
femoral components articulate against tibial and patellar articular surface
to form a total knee system. In addition, two new tibial plates will be
added, a cemented non-porous stem tibial baseplate and a porous
OsseoTiTM stemmed tibial baseplate. All of the new components come in
a variety of sizes to match the needs of a patient's anatomy when
performing total knee arthroplasty. These components are provided
sterile and single use. To aid the implantation of these devices several
new reusable instruments are also introduced. |
| Indications for Use: | When a mechanical alignment approach is utilized, 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. |
| | When a kinematic alignment approach is utilized, 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.
- Moderate valgus, varus, or flexion deformities. |
| | The kinematic alignment (KA) surgical technique may only be used with
Persona porous and cemented non-porous CR femoral components,
Persona CR or UC articular surface components, and the cemented
nonporous Persona Natural cemented 5 degree tibial components without
a stem extension, |
| | Porous coated components may be used cemented or uncemented
(biological fixation), except for the Persona porous 0 degree OsseoTi
Spiked Keel Tibia which is for uncemented use only. All other femoral, |
5
tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella 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 predicate .
- Indications for Use: Similar to the predicate ●
- Materials: Identical to the predicate
- Design Features: Identical and similar to the predicate ●
- Sterilization: Identical to the predicate ●
Summary of Performance Data (Nonclinical and/or Clinical)
- Non-Clinical Tests:
- Posterior condyle fatigue testing per internal test methods. O
- Anterior flange fatigue testing per an internal test method. O
- Evaluation of porous plasma spray (PPS) coating. O
- Evaluation of OsseoTi porous structure. O
- Fatigue strength of the Persona 0° Cemented Keel Tibial o Baseplate per ASTM F1800 and ISO 14879-1.
- Fatigue strength of the Persona 0° Spiked Keel Tibial Baseplate O per ASTM F1800 and ISO 14879-1.
- Evaluation of the level of micromotion of the Persona 0° O OsseoTi tibial baseplate per an internal test method.
- Fixation performance of the Persona 0° Cemented Keel Tibia per о an internal test method.
- Analysis of keel and peg drill perforation rate. O
- Assessment of MR compatibility. O
- O Bacterial Endotoxin Test (BET) per ANSI/AAMI ST 72:2011as part of cleaning validation demonstrating implants meet the limit of Medical Devices - Bacterial Endotoxin and Pyrogen Tests.
6
Clinical Tests: ●
- 0 None provided
Substantial Equivalence Conclusion
Based on the information contained within this submission, it is concluded that the Persona® Personalized Knee System are substantially equivalent to the identified predicate devices.