Persona the Personalized Knee System

K243247 · Zimmer, Inc. · MBH · Oct 29, 2024 · Orthopedic

Device Facts

• Record ID: K243247
• Device Name: Persona the Personalized Knee System
• Applicant: Zimmer, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Oct 29, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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.

Device Story

Persona Personalized Knee System is a semi-constrained modular knee prosthesis; resurfaces articulating surfaces of femoral, tibial, and patella bones. Subject device adds compatibility of Persona OsseoTi 3-Peg Patella to Persona Posterior Stabilized (PS) femoral components; previously only compatible with Cruciate Retaining (CR) femoral variants. Patella components articulate against femoral components; available in various sizes to match patient anatomy. Used in total knee arthroplasty; performed by orthopedic surgeons in clinical/hospital settings. Components provided sterile, single-use. Output is a physical joint replacement; aids in restoring joint function and reducing pain. Benefits include improved mobility and stability for patients with severe knee pathology.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, specifically durability testing per ISO 14243-5 for the Persona OsseoTi 3-Peg Patella with PS femoral components.

Technological Characteristics

Semi-constrained modular knee prosthesis; metal-backed porous patella resurfacing component with direct compression molded UHMWPE articulating surface. Materials include metal and UHMWPE. Designed for uncemented use (biological fixation). Sterilized for single use.

Indications for Use

Indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, post-traumatic joint configuration loss, or moderate valgus/varus/flexion deformities. Also indicated for salvage of failed surgical attempts or knee instability.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Zimmer Persona the Personalized Knee System: Persona OsseoTi 3-Peg Patella (K240299)

Reference Devices

• NexGen Primary Porous Patella (K031462)

Submission Summary (Full Text)

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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.

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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

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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.<br>P.O. Box 708<br>Warsaw, IN 46581-0708<br>Establishment Registration Number: 1822565 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gregory Foster<br>Regulatory Affairs Principal<br>Telephone: [phone]<br>Fax: fax [phone]<br>[e-mail] |
| 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,<br>Uncemented, Porous, Coated, Polymer/Metal/Polymer (21 CFR<br>888.3565 Knee joint patellofemorotibial metal/polymer porous-<br>coated uncemented prosthesis)<br>JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained,<br>Cemented, Polymer/Metal/Polymer (21 CFR 888.3560 Knee joint<br>patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis)<br>OIY- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained,<br>Cemented, Polymer + Additive/Metal/Polymer + Additive (21<br>CFR 888.3560 Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented prosthesis |

# Predicate/Reference Device(s):

| Primary<br>Predicate | K240299 | Zimmer®<br>Persona® the<br>Personalized Knee<br>System: Persona<br>OsseoTi 3-Peg<br>Patella | Zimmer, Inc. |
|----------------------|---------|---------------------------------------------------------------------------------------------|--------------|
| Reference<br>Device | K031462 | NexGen® Primary<br>Porous Patella | Zimmer, Inc. |

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| Device Description: | The purpose of this submission is to add compatibility of the Persona<br>OsseoTi 3-Peg Patella to the Persona® the Personalized Knee System<br>Posterior Stabilized (PS) femoral components. The addition of this<br>compatibility does not change the intended use or fundamental scientific<br>technology of the device system. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Persona® the Personalized Knee System is a semiconstrained<br>modular knee prosthesis designed to resurface the articulating surface of<br>the femoral, tibial, and patella bones. With this submission compatibility<br>of the Persona OsseoTi 3-Peg patella components will be added to the<br>Persona PS femoral components of the knee system. These patella<br>components articulate against femoral component as part of a total knee<br>system. These patellar components come in a variety of sizes to match<br>the needs of a patient's anatomy when performing total knee arthroplasty.<br>These components are provided sterile and single use. |
| Indications for Use: | When a mechanical alignment approach is utilized, this device is<br>indicated for patients with severe knee pain and disability due to:<br>-Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.<br>- Collagen disorders, and/or avascular necrosis of the femoral condyle.<br>- Post-traumatic loss of joint configuration, particularly when there is<br>patellofemoral erosion, dysfunction or prior patellectomy.<br>- Moderate valgus, varus, or flexion deformities.<br>- The salvage of previously failed surgical attempts or for a knee in which<br>satisfactory stability in flexion cannot be obtained at the time of surgery. |
| | When a Personalized Alignment approach is utilized, this device is<br>indicated for patients with severe knee pain and disability due to:<br>- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.<br>- Collagen disorders, and/or avascular necrosis of the femoral condyle.<br>- Moderate valgus, varus, or flexion deformities. |
| | The Personalized Alignment (PA) surgical technique may only be used<br>with Persona cemented and uncemented CR femoral components,<br>Persona CR, Ultra Congruent (UC), and Medial Congruent (MC)<br>articular surface components, the Persona Cemented Stemmed tibial<br>components without a stem extension, and the Persona OsseoTi Keel<br>Tibia and Cemented Keel Tibia. |
| | Porous coated components may be used cemented or uncemented<br>(biological fixation), except for the Persona OsseoTi Keel Tibia and the<br>Persona OsseoTi 3-peg Patella which are for uncemented use only. All<br>other femoral, tibial baseplate and all-polyethylene (UHMWPE and<br>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.