ZIMMER PERSONA KNEE SYSTEM

K113369 · Zimmer, Inc. · JWH · Mar 27, 2012 · Orthopedic

Device Facts

• Record ID: K113369
• Device Name: ZIMMER PERSONA KNEE SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Mar 27, 2012
• Decision: SESE
• Submission Type: Traditional
• 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. This device is intended for cemented use only.

Device Story

Zimmer Persona Personalized Knee System is a semi-constrained modular knee prosthesis; designed to resurface articulating surfaces of femoral, tibial, and patellar bones. System utilizes modular design between tibial plates and articular surfaces. Device is intended for cemented use only. Used in clinical settings by orthopedic surgeons to treat severe knee pain and disability. Components include femoral, tibial, and patellar implants. Device restores joint function and stability; benefits patients by alleviating pain and improving mobility. Performance verified through non-clinical bench testing, including fatigue, wear, constraint, and locking mechanism evaluations.

Clinical Evidence

No clinical data was required or provided for this device. Substantial equivalence was established through non-clinical bench testing, including fatigue testing of the tibia keel/stem, cantilever fatigue, wear testing per ISO 14243, spine fatigue, tibiofemoral constraint evaluation, lateral subluxation force testing, contact area/pressure analysis, and locking mechanism strength testing.

Technological Characteristics

Semi-constrained modular knee prosthesis; metal/polymer construction. Components include femoral, tibial, and patellar implants. Modular design for tibial plates and articular surfaces. Intended for cemented fixation. Testing performed per ISO 14243 for wear. No software or electronic components.

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 knee instability in flexion. Intended for cemented use only.

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

• Natural Knee II System (K936159)
• Gender Solutions Natural Knee Flex System (K070214, K073286)
• NextGen Complete Knee System (K933785)
• NexGen Complete Knee Solution Legacy Posterior Stabilized (PS) and Constrained Condylar Knee (CCK) (K960279)
• NexGen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface Components (K991581)
• NexGen Complete Knee Solution Cruciate Retaining Flex Femoral (CR Flex) Components (K023211)
• NexGen Knee Gender Solutions Female (GSF) Femoral Components (K060370)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside. Below the circle, the word "zimmer" is written in a serif font.

K113369

MAR 2 7 2012

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

### Summary of Safety and Effectiveness

Sponsor:

Contact Person:

Date:

Trade Name:

Product Codes / Device:

Regulation Numbers / Description:

Predicate Device:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Kelli Anderson Project Manager, Regulatory Affairs Telephone: [phone] Fax: [phone]

March 16, 2012

: Zimmer® Persona™ Personalized Knee System

JWH

21 CFR § 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented

Natural Knee II System, manufactured by Zimmer, Inc. (K936159, cleared May 22, 1995)

Gender Solutions™ Natural Knee® Flex System, manufactured by Zimmer, Inc. (K070214, cleared March 16, 2007 and K073286, cleared March 7, 2008)

NextGen Complete Knee System, manufactured by Zimmer, Inc. (K933785, cleared January 30, 1995)

. NexGen Complete Knee Solution Legacy Posterior Stabilized (PS) and Constrained Condylar Knee (CCK), manufactured by Zimmer, Inc. (K960279, cleared April 26, 1996)

NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface Components, manufactured by Zimmer, Inc. (K991581, cleared July 30, 1999)

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NexGen® Complete Knee Solution Cruciate Retaining Flex Femoral (CR Flex) Components, manufactured by Zimmer, Inc. (K023211, cleared October 17, 2002)

NexGen® Knee Gender Solutions Female (GSF) Femoral Components, manufactured by Zimmer, Inc. (K060370, cleared April 28, 2006)

The Zimmer® Persona™ Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces.

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. ।
- . I 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.

This device is intended for cemented use only.

The proposed Zimmer® Persona™ Personalized Knee System components are similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

Non-Clinical Performance and Conclusions:

Device Description:

Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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# K113369

| Property or<br>Characteristic | Test Results |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fatigue Test of the Persona Tibia<br>Keel and Stem Extension | Demonstrated that the Persona tibia keel and stem extension<br>taper junction provide sufficient fatigue strength to survive<br>expected worst case loading conditions. |
| Cantilever Fatigue Test of the<br>Persona Cemented Tibia | Demonstrated adequate fatigue strength in the cantilever<br>loading condition. |
| Wear Testing of Persona CR<br>Conventional Articular Surfaces<br>Under Load and Motion Curves<br>From the ISO 14243 Standard | Demonstrated that the wear characteristics of the Persona<br>CR articular surfaces, when articulated against the Persona<br>CR femoral component, are sufficient to survive expected in<br>vivo loading conditions. |
| Wear Testing of Persona PS<br>Conventional UHMWPE Articular<br>Surfaces Under Load and Motion<br>Curves from the ISO 14243<br>Standard | Demonstrated that the wear characteristics of the Persona PS<br>articular surfaces, when articulated against the Persona PS<br>femoral component, are sufficient to survive expected in vivo<br>loading conditions. |
| Wear Testing of Persona UC<br>Conventional UHMWPE Articular<br>Surfaces Under Displacement<br>Control with Load and Motion<br>Curves from the ISO 14243-1<br>Standard | Demonstrated that the wear characteristics of the Persona<br>UC articular surfaces, when articulated against the Persona<br>CR femoral component, are sufficient to survive expected in<br>vivo loading conditions. |
| Spine Fatigue Evaluation of the<br>Persona PS Conventional<br>UHMWPE Articular Surfaces | Demonstrated that the spine of the Persona PS articular<br>surfaces has sufficient strength to survive expected in vivo<br>stress/strain loading conditions. |
| Tibiofemoral Constraint Evaluation<br>of the Persona Conventional<br>UHMWPE Articular Surface | Demonstrated that constraint values for the Persona articular<br>surfaces are comparable to data from similar NexGen<br>articular surfaces. Therefore, the Persona articular surfaces<br>provide adequate constraint through the needed tibiofemoral<br>flexion angles. |
| Property or<br>Characteristic | Test Results |
| Lateral Constraint Evaluation of<br>the Persona Conventional All-Poly<br>Patellar Component on the Persona<br>CR and PS Femoral Components | Demonstrated that the lateral subluxation force of the<br>Persona conventional all-poly patellar component on the<br>Persona CR and PS femoral implants at tibiofemoral flexion<br>angles 0° to 90° was comparable to control testing on<br>NexGen predicate devcies. |
| Tibiofemoral Contact Area and<br>Contact Pressure Evaluation of the<br>Persona CR/UC/PS Conventional<br>Articular Surfaces | Demonstrated that the contact area and contact pressure of<br>the Persona articular surfaces are comparable to data from<br>previous testing on similar NexGen articular surfaces. |
| Contact Area and Contact Stress<br>Evaluation of the Persona<br>Conventional All-Poly Patellar<br>Component on the Persona<br>Primary CR and PS Femoral<br>Components | Demonstrated that, for all flexion angles, the contact areas<br>were similar between the CR and PS femoral components. |
| Anterior Liftoff Testing of the<br>Persona Articular Surfaces | Demonstrated sufficient locking mechanism strength to<br>survive potential worst case anterior liftoff loading<br>conditions during deep flexion. |
| Posterior Liftoff Fatigue Strength of<br>the Persona Articular Surfaces | Demonstrated sufficient locking mechanism strength to<br>survive potential worst case shear loading conditions. |
| Assembly Testing of the Persona<br>Tibia Locking Mechanism | Demonstrated successful assembly of the modular articular<br>surfaces at normal and maximum interference conditions. |
| Static Shear Strength of the Persona<br>Tibia Locking Mechanism | Demonstrated adequate resistance of the modular articular<br>surfaces to disassembly. |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

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

Zimmer, Inc. % Ms. Kelli J. Anderson Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

MAR 2 7 2012

Re: K113369

Trade/Device Name: Zimmer™ Persona® Personalized Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

Regulatory Class: II Product Codes: JWH Dated: March 16, 2012 Received: March 19, 2012

Dear Ms. Anderson:

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

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## Page 2 - Ms. Kelli J. Anderson

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

P

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

Enclosure

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# Indications for Use

K113369

# 510(k) Number (if known): Jaknown

Device Name:

Persona™ Knee System

# Indications for Use:

This device is indicated for patients with severe knee pain and disability due to:

- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. ー
- 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.

This device is intended for cemented use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter. Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dullel

(Dision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113364

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