PERSONA NATURAL TIBIA BASEPLATES

K130143 · Zimmer, Inc. · JWH · Feb 22, 2013 · Orthopedic

Device Facts

• Record ID: K130143
• Device Name: PERSONA NATURAL TIBIA BASEPLATES
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Feb 22, 2013
• 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. This device is intended for cemented use only.

Device Story

Persona Natural Tibia Baseplate (Size J) replaces proximal tibia; part of Persona Personalized Knee System. Used in orthopedic surgery to restore knee joint function. Device implanted via cemented fixation. Benefits include pain relief and improved joint stability for patients with severe knee disability. Surgeon operates device during total knee arthroplasty. Performance validated via bench testing including fixation, cantilever fatigue, bending fatigue, and cortical impingement/perforation analysis using CT-segmented bone database.

Clinical Evidence

No clinical data. Bench testing only: fixation testing, cantilever fatigue testing, bending fatigue testing of keel/stem extension junction, and cortical impingement/perforation analysis using CT-segmented tibial bone database.

Technological Characteristics

Patellofemorotibial semi-constrained cemented prosthesis. Materials: polymer/metal/polymer. Form factor: Size J tibial baseplate. Fixation: Cemented. Testing: Fixation, cantilever fatigue, bending fatigue, and CT-based cortical impingement analysis.

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. 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

• Persona Natural Tibia Baseplate and Instrumentation (K113369)
• Persona Natural Tibia Baseplate and Instrumentation (K122765)

Submission Summary (Full Text)

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## K130143 (1/2)

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

# FEB 2 2 2013

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#### Summary of Safety and Effectiveness

Sponsor:

Contact Person:

Date:

Trade Name:

Product Code / Device:

Regulation Number / Description:

Predicate Device:

Device Description:

Intended Use:

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

> Nicole J. Meredith Associate Project Manager, Regulatory Affairs Telephone: [phone] Fax: [phone]

January 21, 2013

PersonaTM Natural Tibia™ Baseplates, Size J, and Instrumentation

· JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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

Persona™ Natural Tibia™ Baseplate and Instrumentation, manufactured by Zimmer Inc., K113369, cleared March 27, 2012

Persona™ Natural Tibia™ Baseplate and Instrumentation, manufactured by Zimmer Inc., K122765, cleared November 9, 2012

The Persona Natural Tibia Baseplate is designed to replace the proximal portion of the tibia via cemented fixation as part of the Persona Personalized Knee System.

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

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

The Persona Natural Tibia Baseplate and Instrumentation is similar or identical in intended use, material, sterility, and performance characteristics to the predicate devices.

Non-Clinical Performance and Conclusions:

The following tests have been completed in support of the changes to the Persona Natural Tibia Baseplate: Fixation Testing, Cantilever Fatigue Testing, Bending Fatigue Testing of the keel and stem extension junction, and Cortical Impingement and Perforation Analysis using a database of computed tomography (CT) segmented tibial bones.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

### Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 22, 2013

Zimmer, Incorporated % Ms. Nicole J. Meredith Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708 .

Re: K130143

Trade/Device Name: Persona™ Natural Tibia™ Baseplates, Size J and Instrumentation

Regulation Number: 21 CFR 888.3560

Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

Regulatory Class: Class II Product Code: JWH, OIY Dated: January 21, 2013 Received: January 23, 2013

Dear Ms. Meredith:

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. Nicole J. Meredith

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/ReportalProblem/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 vours.

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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): K130143

## Device Name:

## Persona™ Natural Tibia™ Baseplates, Size J, and Instrumentation

## 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. ー
- -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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

02.21 15:54:54

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