(30 days)
Not Found
No
The summary describes a surgical technique and associated knee system components, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is a knee system intended for patients with severe knee pain and disability due to various conditions, aiming to alleviate pain and restore function, which are therapeutic outcomes.
No
The provided text describes the indications for use and device description of a knee system, which is an implantable medical device for joint replacement. It does not mention any function related to diagnosing diseases or conditions. The device is intended for treating severe knee pain and disability, not for diagnosis.
No
The 510(k) summary describes a "Persona Personalized Knee System" and its components (femoral, tibial, articular surface, patella components), which are clearly hardware implants used in knee replacement surgery. The submission adds a surgical technique indication to this existing hardware 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 describes a device used for surgical implantation to treat severe knee pain and disability due to various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description refers to adding a surgical technique indication to a "Knee System." This further reinforces that it's a surgical implant system.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are designed to perform tests on these types of samples to aid in diagnosis.
- Anatomical Site: The device is used on the knee, which is a part of the body, not a biological sample.
Therefore, this device is a surgical implant system intended for the treatment of knee conditions, 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 Personalized 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 Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.
Porous coated components may be used cemented or uncemented (biological fixation), except for the Persona Osseo Ti Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMVPE 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 the Personalized Alignment surgical technique indication to the Persona Personalized Knee System
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
Prescription Use
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:
- Persona 0° Keel Tibial and Persona PPS Femur Design O Validation - Device Comparison.
- Persona 0° Tibia Keel and Peg Perforation Personalized O Alignment
Clinical Tests:
- None provided o
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.
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
March 8, 2023
Image /page/0/Picture/1 description: The image shows 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Zimmer, Inc. Gregory Foster Sr. Regulatory Affairs Specialist 1800 W. Center Street Warsaw. Indiana 46580
Re: K230321
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: February 3, 2023 Received: February 6, 2023
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 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 -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) K230321
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 Personalized 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 Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.
Porous coated components may be used cemented or uncemented (biological fixation), except for the Persona Osseo Ti Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMVPE 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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: | 03-Feb-2023 |
| Subject Device: | Trade Name: Persona® Personalized Knee System |
| | Common Name: Knee Prosthesis |
| Classification Name: | Classification Name:
JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560) MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained Uncemented, Porous, Coated, Polymer/Metal/Polymer (21 CFR 888.3565) OIY- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (21 CFR 888.3560) |
Predicate Device(s):
| K113369 | Zimmer®
Persona™ Knee
System | Zimmer, Inc. |
|---------|------------------------------------|--------------|
| K172524 | Zimmer®
Persona™ Knee
System | Zimmer, Inc. |
| K221479 | Zimmer®
Persona™ Knee
System | Zimmer, Inc. |
Device Description:
The purpose of this submission is to add the Personalized Alignment surgical technique indication to the Persona Personalized Knee System
4
| 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 Personalized 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 Personalized Alignment (PA) surgical technique may only be used
with Persona cemented and uncemented CR femoral components,
Persona CR, Ultra Congruent (UC), and Medial Congruent (MC)
articular surface components, the Persona Cemented Stemmed tibial
components without a stem extension, and the Persona OsseoTi Keel
Tibia and Cemented Keel Tibia. |
| | Porous coated components may be used cemented or uncemented
(biological fixation), except for the Persona OsseoTi Keel Tibia which is
for uncemented use only. All other femoral, tibial baseplate and all-
polyethylene (UHMWPE and VEHXPE) patella components are
indicated for cemented use only. |
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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
- o Design Features: Identical to the predicate
- Sterilization: Identical to the predicate ●
Summary of Performance Data (Nonclinical and/or Clinical)
o Non-Clinical Tests:
- Persona® 0° Keel Tibial and Persona® PPS® Femur Design O Validation - Device Comparison.
- Persona 0° Tibia Keel and Peg Perforation Personalized O Alignment
Clinical Tests: ●
- None provided o
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.