Persona Revision Knee System

K210551 · Zimmer, Inc. · JWH · Mar 18, 2021 · Orthopedic

Device Facts

• Record ID: K210551
• Device Name: Persona Revision Knee System
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Mar 18, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. Porous components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.

Device Story

Persona Revision Knee System is a semi-constrained total knee prosthesis; includes femoral components, articular surfaces, tibial components, stem extensions, augments, and cones. Designed to resurface articulating surfaces of femoral and tibial bones. Used in primary or revision total knee arthroplasty (TKA) surgery. Modular components allow configuration to address specific patient bone and joint conditions. Implanted by orthopedic surgeons in clinical/OR settings. Includes non-implantable instrumentation for implantation and sterilization/storage cases. Provides joint stability and pain relief for patients with severe knee disability.

Clinical Evidence

No clinical or non-clinical testing required to support the proposed changes to contraindications.

Technological Characteristics

Semi-constrained total knee prosthesis; modular design including femoral/tibial components, augments, cones, and stem extensions. Materials, design, and sterilization methods are identical to the predicate device. Components utilize cemented or uncemented (press-fit/biological) fixation depending on specific part type.

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 femoral condyle, post-traumatic joint loss, or moderate valgus/varus/flexion deformities. Also indicated for salvage of failed surgical attempts or knees lacking flexion stability.

Regulatory Classification

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).

Predicate Devices

• Persona Revision Knee System (K191625)

Submission Summary (Full Text)

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March 18, 2021

Image /page/0/Picture/1 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zimmer, Inc. Romil Sheth Regulatory Affairs Project Manager 1800 W. Center Street Warsaw, Indiana 46580

Re: K210551

Trade/Device Name: Persona Revision 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 23, 2021 Received: February 25, 2021

Dear Romil Sheth:

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

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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 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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) Not Known

K210551

Device Name Persona Revision Knee System

Indications for Use (Describe)

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 confi guration, 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.

Porous components may be used cemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and fibial augment 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)

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# 510(k) Summary

| Sponsor: | Zimmer, Inc.<br>1800 W. Center Street<br>Warsaw, IN 46580<br>Establishment Registration Number: 1822565 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Romil Sheth<br>Regulatory Affairs Project Manager<br>Telephone: [phone])<br>[e-mail] |
| Date: | March 16, 2021 |
| Subject Device: | Trade Name: Persona® Revision Knee System<br>Common Name: Knee Prosthesis<br>Classification Name:<br>JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560 – Knee joint Patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis) 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) 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 Device(s): | K191625 Persona Revision Knee System Zimmer, Inc. |

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## Device Description:

The purpose of this submission is to obtain clearance for the proposed changes to the contraindications for the Persona Revision Knee System. The proposed contraindications changes are to align the use of Persona Revision Knee System with the current standard practice of revision knee prostheses and for clarification purpose.

The Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including:

- Femoral components ●
- Articular surfaces
- Tibial components
- . Stem extensions
- Femoral and tibial augments ●
- Femoral and tibial cones

The large modularity of the componentry of the Persona Revision Knee System including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery.

The Persona Revision Knee System also includes nonimplantable tools, or instrumentation, that facilitate the implantation of above described implant components as well as cases and trays to hold these instruments during sterilization and their subsequent storage.

Indications for Use:

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.

Porous components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment 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: Same as the predicate device. ●
- Materials: Same as the predicate device.
- Design Features: Same as the predicate device.
- Sterilization: Same as the predicate device. .

## Summary of Performance Data (Nonclinical and/or Clinical)

Non-clinical or clinical tests are not needed to support the proposed changes to contraindications.

Substantial Equivalence Conclusion

Based on the information contained within this submission, it is concluded that the Persona Revision Knee System is substantially equivalent to the identified predicate device.