(63 days)
Not Found
No
The document describes a knee prosthesis and surgical technique modifications, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
Yes
The device is a knee prosthesis designed to alleviate severe knee pain and disability, which aligns with the definition of a therapeutic device.
No
The device is a knee prosthesis, which is an implant used to resurface the articulating surfaces of bones in the knee, not to diagnose a condition.
No
The device description explicitly states it is a "semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones," which are physical implant components, not software.
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 the device as a treatment for severe knee pain and disability due to various conditions affecting the knee joint. This is a therapeutic indication, not a diagnostic one.
- Device Description: The device is described as a "semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones." This is a description of an implantable medical device used for surgical intervention, not for performing tests on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
The device is clearly a surgical implant used to replace or resurface parts of the knee joint.
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 Conqruent (MC) articular surface components, the Persona Cemented Stemmed tibial components, 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH, OIY
Device Description
The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones.
The purpose of this submission is to add compatibility for cemented nonporous Persona tibial components with a stem extension to the current Personalized Alignment (PA) surgical technique option. In addition to the modifications regarding personalized alignment, this submission also discusses the updated geometric evaluations for the Persona Personalized Knee System as well as the shelf-life extension (5 years to 10 years) of its Vivacit-E VEXLPE implant 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)
The performance data provided in the performance testing section indicate the proposed devices meet the established acceptance criterion; therefore, are as safe and effective and substantially equivalent to the legally marketed predicate devices from a performance standpoint.
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
§ 888.3565 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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 20, 2024
Zimmer Biomet Adam Haas Regulatory Affairs Senior Specialist 1800 W Center St Warsaw, Indiana 46580
Re: K243293
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 Codes: MBH, JWH, OIY Dated: October 18, 2024 Received: October 18, 2024
Dear Adam Haas:
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,
For
Peter G. Allen - Digitally signed by Peter G.
S Allen -S
Date: 2024.12.20 13:55:20
-05'00'
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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 Conqruent (MC) articular surface components, the Persona Cemented Stemmed tibial components, 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 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.
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.
1800 W. Center Street
Warsaw, IN 46580
Establishment Registration Number: 1822565 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Adam Haas
Regulatory Affairs Senior Specialist
Telephone: (908-361-7475)
Adam.Haas@zimmerbiomet.com |
| Date: | Dec 17, 2024 |
| Subject Device: | Trade Name: Zimmer® Persona® Personalized Knee System
Common Name: Total Knee Prosthesis
Primary 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) Additional Classification Names:
JWI - prosthesis, wrist, 2 part metal-plastic articulation semi-constrained (21 CFR 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesisOIY - rosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive (21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis) |
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Primary Predicate Device:
510(k) | Device Name | Applicant |
---|---|---|
K240299 | Zimmer® Persona® | |
Personalized Knee System | Zimmer, Inc. |
Secondary Predicate Device:
510(k) | Device Name | Applicant |
---|---|---|
K222566 | Zimmer® Persona® | |
Personalized Knee System | Zimmer, Inc. |
Device Description:
The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones.
The purpose of this submission is to add compatibility for cemented nonporous Persona tibial components with a stem extension to the current Personalized Alignment (PA) surgical technique option. In addition to the modifications regarding personalized alignment, this submission also discusses the updated geometric evaluations for the Persona Personalized Knee System as well as the shelf-life extension (5 years to 10 years) of its Vivacit-E VEXLPE implant components.
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.
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-
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 cemented nonporous Persona tibial components with or 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.
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Same as the predicate device. .
- . Indications for Use: Similar to the predicate device. Overall indications for use remain the same. The primary difference is the removal of the compatibility limitation regarding cemented nonporous Persona tibial components compared to the predicate
- Variants/Sizes: Same as the predicate device. ●
- . Design Features: Similar to the predicate device
- Material: Same as the predicate device
- Sterility: Same as the predicate device. ●
- Shelf Life: Similar, Metallic and conventional UHMWPE implant components retain predicate shelf
7
life of 10 and 5 years respectively. Vivacit-E VEXLPE implant components now have a 10 year shelf life.
Summary of Performance Data (Nonclinical and/or Clinical):
Substantial Equivalence
Conclusion:
The performance data provided in the performance testing section indicate the proposed devices meet the established acceptance criterion; therefore, are as safe and effective and substantially equivalent to the legally marketed predicate devices from a performance standpoint.
The subject device, the Persona Personalized Knee System, has similar Indications for Use, and shelf-life, to the predicate device. Similarly, the subject device has an identical intended use, design features, materials of constuction, performance, and sterility as its predicate device. Therefore the Persona Personalized Knee System (K240299) and the information provided demonstrates:
· any differences do not raise new questions of safety and effectiveness; and
· the proposed device is at least as safe and effective as the legally marketed predicate device.