ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)

K091263 · Materialise NV · JWH · Nov 19, 2009 · Orthopedic

Device Facts

• Record ID: K091263
• Device Name: ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)
• Applicant: Materialise NV
• Product Code: JWH · Orthopedic
• Decision Date: Nov 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2

Intended Use

The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing and Zimmer NEXGEN LPS-FLEX fixed bearing prostheses families only. The Zimmer Patient Specific Instruments are intended for single use only.

Device Story

System comprises software (Zimmer Patient Specific Instruments Planner) and hardware (patient-specific cutting blocks). Input: MRI imaging data. Process: Software generates pre-surgical plan; surgeon inspects, fine-tunes, and approves plan; patient-specific templates manufactured based on approved plan. Output: Physical templates used intraoperatively to guide bone marking and positioning of total knee replacement components. Used in clinical setting by surgeons. Benefits: Assists in accurate positioning and alignment of knee implants.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

System includes software for surgical planning and patient-specific hardware templates. Designed for use with specific Zimmer NEXGEN knee prosthesis families. Single-use device.

Indications for Use

Indicated for patients undergoing total knee replacement surgery requiring the use of Zimmer NEXGEN CR-FLEX or LPS-FLEX fixed bearing prostheses. Intended for use by surgeons to assist in intraoperative component positioning and bone marking.

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

• Patient Matched Cutting Blocks (K082358)

Submission Summary (Full Text)

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K091263
P 1/2

11,

# 510(k) Summary

..

NOV 1 9 2009

#### Submitter information

| Company name | Materialise N.V. |
|-----------------------------------|------------------------------|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | [phone] |
| Fax number | [phone] |
| Contact name | Karl vom Berge |
| Contact title | Product Manager |
| Contact e-mail address | [e-mail] |

#### Submission date

The date of the Traditional 510(k) submission is April 29th, 2009. The date of the Additional Information request submission is August 4th 2009.

#### Submission information

| Trade Name | Zimmer Patient Specific Instruments<br>Zimmer Patient Specific Instruments Planner |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Knee prosthesis |
| Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis<br>Knee joint patellofemorotibial.<br>metal/polymer porous-coated uncemented prosthesis |
| Product code | JWH (21 CFR § 888.3560) and MBH (21 CFR § 888.3565) |

#### Predicate device

| Predicate Device | |
|---------------------------------------|--------------------------------|
| Trade or proprietary or model<br>name | Patient Matched Cutting Blocks |
| 510(k) number | K082358 |
| Decision date | 11/25/2008 |
| Product code | JWH, MBH |
| Manufacturer | Smith and Nephew, Inc. |

### Device Information

#### Description of the device

The Zimmer Patient Specific Instruments System consists of a software component, Zimmer Patient Specific Instruments Planner and a hardware component, Zimmer Patient Specific Instruments and is designed to assist the surgeon in the placement of total knee

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replacement components for Zimmer NEXGEN CR-FLEX fixed bearing and Zimmer NEXGEN LPS-FLEX fixed bearing prostheses families.

#### Functioning of the device

The Zimmer Patient Specific Instruments System generates a pre-surgical plan based on MRI imaging data using the Zimmer Patient Specific Instruments Planner (software component). The software is then used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Zimmer Patient Specific Instruments are designed and manufactured based on the approved pre-surgical plan. Zimmer Patient Specific Instruments are patient specific templates that transfer the pre-operatively determined positioning of the Total Knee Replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual Total Knee Replacement components by guiding and marking drill locations.

#### Intended use

The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing and Zimmer NEXGEN LPS-FLEX fixed bearing prostheses families only.

The Zimmer Patient Specific Instruments are intended for single use only.

## Summary of technological characteristics

Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device.

## Performance data

#### Non-clinical tests

Non-clinical tests were performed to assess the safety and effectiveness of the device. Testing verified that the accuracy and performance of the system is adequate to perform as intended.

#### Clinical data

Not applicable.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

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

APR 1 5 2011

Materialise N.V. % Mr. Karl vom Berge Technologielaan 15 3001 Leuven Belgium

Re: K091263

Trade/Device Name: Zimmer Patient Specific Instruments System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OOG, JWH Dated: October 22, 2009 Received: October 26, 2009

Dear Mr. vom Berge:

This letter corrects our substantially equivalent letter of November 19, 2009.

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 (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.

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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Page 2 - Mr. Karl vom Berge

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 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,

Hy B. Rake

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

#### 510(k) Number (if known): K091263

Device Name: Zimmer Patient Specific Instruments System (Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner)

Indications For Use:

The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing and Zimmer NEXGEN LPS-FLEX fixed bearing prostheses families only.

The Zimmer Patient Specific Instruments are intended for single use only.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R.P. Ozhe for mxm

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

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510(k) Number: K091263