ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0

K093533 · Materialise NV · MBH · Feb 17, 2010 · Orthopedic

Device Facts

• Record ID: K093533
• Device Name: ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0
• Applicant: Materialise NV
• Product Code: MBH · Orthopedic
• Decision Date: Feb 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• 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 intra-operatively 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, Zimmer NEXGEN LPS-FLEX fixed bearing and Zimmer Gender Solutions Natural – Knee 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 templates). Input: MRI imaging data. Process: Software generates pre-surgical plan; surgeon inspects, fine-tunes, and approves plan; templates manufactured based on approved plan. Output: Patient-specific templates used intra-operatively to guide bone marking and positioning of total knee replacement components. Used in clinical setting by qualified surgeons. Benefits: Assists surgeon in accurate positioning and alignment of knee implants.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

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

Indications for Use

Indicated for patients undergoing total knee replacement requiring assistance with component positioning and bone marking. Compatible only with Zimmer NEXGEN CR-FLEX, NEXGEN LPS-FLEX, and Gender Solutions Natural-Knee Flex fixed bearing prostheses. Single use only.

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

• Patient Matched Cutting Blocks (K082358)

Submission Summary (Full Text)

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K093533 #1/2

# 510(k) Summary

# 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 November 13th, 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 metal/polymer porous-coated<br>uncemented prosthesis |
| Product code | JWH (21 CFR § 888.3560) and MBH (21 CFR § 888.3565) |

# Predicate device

| Predicate Device | |
|------------------------------------|--------------------------------|
| Trade or proprietary or model 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 replacement components for Zimmer Gender Solutions Natural – Knee Flex fixed bearing prostheses families.

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K093533#a/2

#### 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 intra-operatively 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, Zimmer NEXGEN LPS-FLEX fixed bearing and Zimmer Gender Solutions Natural - Knee 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Materialise N.V. % Mr. Karl vom Berge l 5 Technologielaan Leuven Belgium 3001

FEB 1 7 2010

Re: K093533

Trade/Device Name: Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: November 13, 2009 Received: November 19, 2009

Dear Mr. vom Berge:

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

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Page 2 – Mr. Karl vom Berge

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 mumber [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

signature
ACTING
DSORD DIRECTOR

FOR

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): K0935333

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 intra-operatively 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, Zimmer NEXGEN LPS-FLEX fixed bearing and Zimmer Gender Solutions Natural – Knee 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)

FOR M. MELKERSON

ision Sign-Off Division Sign-Oical, Orthopedic, Orthopedic, Division of Surgical Divisionative Devices

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K093533

510(k) Number