Zimmer Persona Personalized Knee System

K150090 · Zimmer, Inc. · MBH · May 20, 2015 · Orthopedic

Device Facts

• Record ID: K150090
• Device Name: Zimmer Persona Personalized Knee System
• Applicant: Zimmer, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: May 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• 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 coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

Device Story

Zimmer Persona Personalized Knee System is a semi-constrained modular knee prosthesis for resurfacing femoral, tibial, and patellar articulating surfaces. System includes femoral components, tibial baseplates, and articular surface components. Subject submission adds Medial Congruent (MC) Vivacit-E articular surfaces. Components lock onto existing tibial baseplates via dovetail mechanism; articulate against existing Cruciate Retaining (CR) femoral components. MC surfaces provide greater medial conformity; accommodate active flexion up to 155°; can be implanted with or without functioning PCL. Used in orthopedic surgery; implanted by surgeons in hospital settings. Single-use, sterile devices. Benefits include restoration of joint function, stability, and pain relief for patients with severe knee pathology.

Clinical Evidence

No clinical data was required or provided for this device. Equivalence was established through non-clinical bench testing, including wear performance, constraint evaluation, contact mechanics, and MRI compatibility assessments.

Technological Characteristics

Modular knee prosthesis; components include femoral, tibial baseplate, and articular surfaces. Materials: Vivacit-E (UHMWPE) articular surfaces, metal/polymer porous-coated components. Design features: dovetail locking mechanism for articular surfaces. MRI compatible under conditions defined for predicate. Sterilization: provided sterile.

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 loss, or moderate valgus/varus/flexion deformities. Also indicated for salvage of failed surgical attempts or knees lacking stability in flexion.

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

• PersonaTM Personalized Knee System (K121771)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2015

Zimmer, Incorporated Ms. Andrea Pilon Artman Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

Re: K150090 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 Code: MBH, OIY, JWH Dated: April 15, 2015 Received: April 16, 2015

Dear Ms. Artman:

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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Andrea Pilon Artman

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known)

K150090

Device Name

Zimmer® Persona® Personalized 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 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 coated components may be used cemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

Type of Use (Select one or both, as applicable)

2 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 |
|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Andrea Pilon Artman<br>Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | April 28, 2015 |
| Trade Name: | Zimmer® Persona® Personalized Knee System |
| Product Codes / Device: | MBH, OIY, JWH |
| Regulation / Description: | 21 CFR § 888.3565 – Knee joint patellofemorotibial<br>metal/polymer porous-coated uncemented prosthesis<br>21 CFR § 888.3560 – Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented<br>prosthesis |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | PersonaTM Personalized Knee System, manufactured by<br>Zimmer, Inc. (K121771, cleared November 7, 2012) |
| Purpose and Device<br>Description: | The Zimmer Persona Personalized Knee System is a semi-<br>constrained modular knee prosthesis designed to resurface<br>the articulating surface of the femoral, tibial and patellar<br>bones. The Persona Knee System utilizes a modular<br>design between the tibial plates and articular surfaces. With<br>this submission, Medial Congruent (MC) Vivacit-E®<br>articular surface components are being added to the system.<br>The subject components articulate against, the existing<br>Cruciate Retaining (CR) femoral component, and lock onto<br>the existing tibial baseplate components using a dovetail<br>mechanism. The subject articular surface components,<br>when used with the CR femoral, can accommodate a<br>maximum active flexion of 155°. The MC articular |
| | surfaces provide greater medial conformity, similar anterior lateral conformity, and less posterior lateral conformity when compared to the predicate Persona UC articular surface design. In addition, the subject articular surface can be implanted with or without a functioning PCL. The components are single use and are provided sterile to the healthcare facility/hospital. MC articular surfaces are for use with both cemented and uncemented femoral and tibial baseplate components. |
| Intended Use: | This device is 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 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 satisfactory stability in flexion cannot be obtained at the time of surgery. |
| | Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only. |
| Comparison to Predicate Device: | The proposed Zimmer Persona Personalized Knee System components identical in intended use, materials, sterility, and are identical or similar in performance characteristics to the predicate devices. Testing described below was completed to demonstrate equivalence to the predicate devices. |
| Performance Data (Nonclinical and/or Clinical): | Clinical Performance and Conclusion:<br>Clinical data and conclusions were not needed for this device. |
| Property or Characteristics | Analysis/Test Results |
| Biocompatibility testing Vivacit-E<br>UHMWPE | The proposed Persona MC articular surfaces are manufactured<br>from identical material as the predicate device. Therefore, in<br>terms of biocompatibility, the subject devices are substantially<br>equivalent. |
| Evaluation of the Wear Performance<br>of the Persona Medial Congruent<br>Vivacity-E Articular Surfaces | This evaluation demonstrated the wear characteristics of the<br>subject articular surfaces are expected to be equivalent to the<br>predicate articular surface. |
| Tibiofemoral Constraint Evaluation<br>of the Persona Medial Congruent<br>Vivacit-E Articular Surfaces | Determined the anterior-posterior, medial-lateral, internal-<br>external and varus-valgus constraint of the Persona MC Vivacit-E<br>articular surfaces through the necessary tibiofemoral flexion<br>movements. |
| Tibiofemoral Contact Area and<br>Contact Pressure Evaluation of the<br>Persona Medial Congruent Vivacit-E<br>Articular Surfaces | Determined the contact area and contact pressure of the Persona<br>MC Vivacit-E articular surfaces through the necessary<br>tibiofemoral flexion movements. |
| Anterior and Posterior Liftoff<br>Testing of the Persona MC Vivacit-E<br>UHMWPE Articular Surfaces | This evaluation demonstrated that the locking mechanism of the<br>subject articular surfaces is equivalent to the predicate articular<br>surfaces. |
| Evaluation of Interactions with the<br>Magnetic Fields in the Magnetic<br>Resonance Imaging (MRI)<br>Environment | This evaluation demonstrated that the Persona MC components<br>can be used under the same MRI conditions previously defined<br>for the predicate device system. |
| Posterior Crush Evaluation for the<br>Persona Medial Congruent articular<br>surface | This evaluation demonstrated the stress response in the MC<br>articular surfaces when subjected to posterior crush edge loading<br>conditions in deep flexion and in walking gait is equivalent to the<br>predicate articular surfaces. |

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Non-Clinical Performance and Conclusions: Vivacit-E material characteristics for the MC articular surfaces are identical to the material characteristics of the currently marketed Zimmer Persona Vivacit-E articular surfaces (K121771, predicate device).

Performance testing and analyses were conducted on the proposed device per FDA's Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses and Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, as well as the standards identified in the test descriptions below.