(85 days)
Not Found
No
The summary describes a knee prosthesis and associated instruments, focusing on material properties 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 designed to resurface the knee bones, which provides therapy by alleviating severe knee pain and disability caused by various conditions.
No
The device is a knee prosthesis designed to resurface bones, not to diagnose medical conditions.
No
The device description explicitly states it is a "semiconstrained modular knee prosthesis designed to resurface of the femoral, tibial, and patellar bones" and includes "new reusable instruments." This indicates the device is a physical implant and associated surgical tools, not software.
Based on the provided text, 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 knee prosthesis for treating severe knee pain and disability due to various conditions. This involves surgical implantation to replace or resurface parts of the knee joint.
- Device Description: The device is described as a "semiconstrained modular knee prosthesis designed to resurface of the femoral, tibial, and patellar bones." It is a physical implant.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of biological samples or diagnostic purposes.
- Performance Studies: The performance studies listed focus on the mechanical properties, durability, and heating characteristics of the implant itself, not on the analysis of biological samples.
Therefore, this device is a surgical implant and 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 a new component to the Personalized Knee System. The component is the Persona OsseoTi 3-Peq Patella and the associated instruments. The addition of these components do not change the intended use or fundamental scientific technology of the device system.
The Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface of the femoral, tibial, and patellar bones. With this submission a new porous metal backed UHMWPE patella component will be added to the system. These patellar components articulate against femoral component as part of a total knee system. The new 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. 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
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)
Shear and Torsional Strength of the Persona Link OsseoTi Patella Polyethylene -Ti6Al4V Interface
Fatigue Strength of the Persona OsseoTi Porous Patella in an Undersupported Bending Configuration and Manufactured Using PQ Process Parameters
Shear Fatigue Strength of Persona OsseoTi Porous Patella Pegs Manufactured Using PQ Process Parameters
Durability Testing, per ISO 14243-5, for the Persona OsseoTi 3- Peg Patella when Articulated with a Persona CR Femoral Component
Expanded In Vivo RF-Induced Heating Simulations for the Persona Primary Knee System
Characterization of As-Printed Four-Point Bend Fatigue Strength
Evaluation of the Interfacial Motion Between the Persona OsseoTi Patella and a Bone Analog When Subjected to Physiologically Derived Patellofemoral Joint Kinetics and Kinematics
Characterization of OsseoTi Lattice
Clinical Testing Not Applicable
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 logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 26, 2024
Zimmer, Inc. Gregory Foster Regulatory Affairs Principal 1800 W. Center Street Warsaw, Indiana 46580
Re: K240299
Trade/Device Name: Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) 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: April 5, 2024 Received: April 5, 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.
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"
1
(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 OS 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.
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-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, | |
|---|---|
| Peter G. | Digitally signed by Peter G. Allen -S |
| Allen -S | Date: 2024.04.26 |
| 13:16:43 -04'00' |
For Lixin Liu, 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
2
Indications for Use
Submission Number (if known)
Device Name
Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
| 510(k) #: K240299 | 510(k) Summary | Prepared on: 2024-04-05 |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Zimmer, Inc. | |
| Applicant Address | 1800 W. Center Street Warsaw IN 46580 United States | |
| Applicant Contact Telephone | (574) 371-0519 | |
| Applicant Contact | Dr. Gregory Foster | |
| Applicant Contact Email | gregory.foster@zimmerbiomet.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | |
| Common Name | joint patellofemorotibial metal/polymer porous-coated uncemented | |
| prosthesis | ||
| Classification Name | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, | |
| Porous, Coated, Polymer/Metal/Polymer | ||
| Regulation Number | 888.3565 | |
| Product Code(s) | MBH, JWH, OIY | |
| Legally Marketed Predicate Devices | ||
| 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K031462 | Nexgen Primary Porous Patella | MBH |
| K073286 | Gender Solutions Natural-Knee Flex System: Natural Knee Flex | JWH |
| K221479 | Persona OsseoTi™ 0° Porous Keel Tibia Baseplates | JWH |
Device Description Summary
The purpose of this submission is to add a new component to the Personalized Knee System. The component is the Persona OsseoTi 3-Peq Patella and the associated instruments. The addition of these components do not change the intended use or fundamental scientific technology of the device system.
The Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface of the femoral, tibial, and patellar bones. With this submission a new porous metal backed UHMWPE patella component will be added to the system. These patellar components articulate against femoral component as part of a total knee system. The new 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. To aid the implantation of these devices several new reusable instruments are also introduced.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(4)
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.
4
-
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 patellectorny.
-
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.
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.
Indications for Use Comparison
The indications are similar between the subject device, with the exception that the predicate is for cemented and uncemented use, and the subject device is for uncemented use only.
Technological Comparison
The subject and predicate devices are both metal-backed porous patellar resufacing prostheses, with a direct compression molded UHMWPE articulating surface. The articulating geometry are equivalent between the subject devices. The difference is that the predicate has a Trabecular Metal(TM) porous bone-contacting surface and a single peq, while the subject device has an OsseoTi (TM) additive manufactured porous surface and a 3 peg configuration.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Shear and Torsional Strength of the Persona Link OsseoTi Patella Polyethylene -Ti6Al4V Interface
Fatigue Strength of the Persona OsseoTi Porous Patella in an Undersupported Bending Configuration and Manufactured Using PQ Process Parameters
Shear Fatigue Strength of Persona OsseoTi Porous Patella Pegs Manufactured Using PQ Process Parameters
Durability Testing, per ISO 14243-5, for the Persona OsseoTi 3- Peg Patella when Articulated with a Persona CR Femoral Component
Expanded In Vivo RF-Induced Heating Simulations for the Persona Primary Knee System
Characterization of As-Printed Four-Point Bend Fatigue Strength
Evaluation of the Interfacial Motion Between the Persona OsseoTi Patella and a Bone Analog When Subjected to Physiologically Derived Patellofemoral Joint Kinetics and Kinematics
Characterization of OsseoTi Lattice
Clinical Testing Not Applicable
The proposed device has the same intended use as the proposed device has similar technological characteristics to the predicate(s), and the information provided herein demonstrates that:
· 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(s).
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)