(18 days)
No
The document describes a knee prosthesis and its components, focusing on materials, compatibility, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a knee prosthesis indicated for patients with severe knee pain and disability due to various conditions, which are health problems being treated or managed. Therefore, it is a therapeutic device.
No
This device is a knee prosthesis, specifically a knee system designed to resurface the articulating surfaces of the knee bones. Its purpose is to treat severe knee pain and disability by replacing parts of the joint, not by diagnosing conditions.
No
The device description explicitly states it is a "semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patella bones," and mentions "patella components," "femoral components," and "tibial components," indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patella bones." This is a surgical implant, not a diagnostic test performed on a sample.
- Intended Use: The intended use describes the conditions for which the knee prosthesis is indicated (e.g., severe knee pain due to arthritis, deformities). This is related to treating a condition, not diagnosing it.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or any other activities typically associated with IVDs.
Therefore, this device is a surgical implant used for total knee arthroplasty, 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 (biological fixation), except for the Persona OsseoTi Keel Tibia and the Persona OsseoTi 3-peg Patella which are for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH, OIY
Device Description
The purpose of this submission is to add compatibility of the Persona OsseoTi 3-Peg Patella to the Persona® the Personalized Knee System Posterior Stabilized (PS) femoral components. The addition of this compatibility does not change the intended use or fundamental scientific technology of the device system.
The Persona® the Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patella bones. With this submission compatibility of the Persona OsseoTi 3-Peg patella components will be added to the Persona PS femoral components of the knee system. These patella components articulate against femoral component as part of a total knee system. These patellar 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.
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)
Non-Clinical Tests:
- Durability Testing, per ISO 14243-5, Persona OsseoTi 3-Peg . Patella with Size 9 PS Femur
- . Durability Testing, per ISO 14243-5, Persona OsseoTi 3-Peg Patella with Size 12 PS Femur
- Durability Performance of the NexGen TM Patella per ISO . 14243-5
- Durability Testing, per ISO 14243-5, 35 mm NexGen TM Patella . with SZ 12 PS Femur
Clinical Tests: None provided
Key Results: The proposed device has the same intended use as the predicate(s). The proposed device has identical technological characteristics to the predicate(s), and the information provided herein demonstrates that:
- any differences do not raise different questions of safety and effectiveness; and
- the proposed device is at least as safe and effective as the legally marketed predicate device(s).
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.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
October 29, 2024
Zimmer, Inc. Gregory Foster Regulatory Affairs Principal 1800 W. Center Street Warsaw, Indiana 46580
Re: K243247
Trade/Device Name: Persona the 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, JWH, OIY Dated: October 11, 2024 Received: October 11, 2024
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Lixin Liu -S
Lixin Liu, PhD 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) K243247
Device Name
Persona® the 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 (biological fixation), except for the Persona Osseo Ti Keel Tibia and the Persona OsseoTi 3-peg Patella which are for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
Type of Use (Select one or both, as applicable)
X 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
Establishment Registration Number: 1822565 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gregory Foster
Regulatory Affairs Principal
Telephone: (574) 371-0519
Fax: fax (574) 377-3718
Gregory.foster@zimmerbiomet.com |
| Date: | October 28, 2024 |
| Subject Device: | Trade Name: Persona® the Personalized Knee System |
| | Common Name: Knee Prosthesis |
| Classification Name: | Classification Name: |
| | MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained,
Uncemented, Porous, Coated, Polymer/Metal/Polymer (21 CFR
888.3565 Knee joint patellofemorotibial metal/polymer porous-
coated uncemented prosthesis)
JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained,
Cemented, Polymer/Metal/Polymer (21 CFR 888.3560 Knee joint
patellofemorotibial polymer/metal/polymer semi-constrained
cemented prosthesis)
OIY- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained,
Cemented, Polymer + Additive/Metal/Polymer + Additive (21
CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented prosthesis |
Predicate/Reference Device(s):
| Primary
Predicate | K240299 | Zimmer®
Persona® the
Personalized Knee
System: Persona
OsseoTi 3-Peg
Patella | Zimmer, Inc. |
|----------------------|---------|---------------------------------------------------------------------------------------------|--------------|
| Reference
Device | K031462 | NexGen® Primary
Porous Patella | Zimmer, Inc. |
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| Device Description: | The purpose of this submission is to add compatibility of the Persona
OsseoTi 3-Peg Patella to the Persona® the Personalized Knee System
Posterior Stabilized (PS) femoral components. The addition of this
compatibility does not change the intended use or fundamental scientific
technology of the device system. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Persona® the Personalized Knee System is a semiconstrained
modular knee prosthesis designed to resurface the articulating surface of
the femoral, tibial, and patella bones. With this submission compatibility
of the Persona OsseoTi 3-Peg patella components will be added to the
Persona PS femoral components of the knee system. These patella
components articulate against femoral component as part of a total knee
system. These patellar 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. |
| 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 and the
Persona OsseoTi 3-peg Patella which are 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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Indications for Use Comparison: The indications for Use are identical between the predicate and the subject device. The subject and predicate devices are identical metal-backed porous Technological Comparison: patella resurfacing prostheses, with a direct compression molded UHMWPE articulating surface. The articulating geometry are identical between the predicate and the subject devices. The difference is that the predicate is only compatible with the CR femoral variants of the Persona the Personalized Knee System, while the subject device is compatible with both the PS and CR variants of the femoral components.
Non-Clinical and/or Clinical Tests (Summary & Conclusions):
Non-Clinical Tests:
- Durability Testing, per ISO 14243-5, Persona OsseoTi 3-Peg . Patella with Size 9 PS Femur
- . Durability Testing, per ISO 14243-5, Persona OsseoTi 3-Peg Patella with Size 12 PS Femur
- Durability Performance of the NexGen TM Patella per ISO . 14243-5
- Durability Testing, per ISO 14243-5, 35 mm NexGen TM Patella . with SZ 12 PS Femur
Clinical Tests:
None provided
The proposed device has the same intended use as the predicate(s). The proposed device has identical technological characteristics to the predicate(s), and the information provided herein demonstrates that:
- · any differences do not raise different questions of safety and effectiveness; and
- · the proposed device is at least as safe and effective as the legally marketed predicate device(s).
Substantial Equivalence Conclusion:
Based on the information contained within this submission, it is concluded that the Persona® the Personalized Knee System are substantially equivalent to the identified predicate device.