ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS

K111492 · Materialise NV · JWH · Oct 13, 2011 · Orthopedic

Device Facts

• Record ID: K111492
• Device Name: ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS
• Applicant: Materialise NV
• Product Code: JWH · Orthopedic
• Decision Date: Oct 13, 2011
• 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 intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN CR fixed bearing, Zimmer NEXGEN LPS-FLEX fixed bearing, Zimmer NEXGEN LPS 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: patient MRI imaging data. Operation: software generates pre-surgical plan; surgeon inspects, fine-tunes, and approves plan; templates manufactured based on approved plan. Usage: intra-operative, by qualified surgeon. Function: templates transfer pre-operatively determined positioning to patient, guiding/marking drill locations for total knee replacement components. Benefit: assists surgeon in accurate positioning and alignment of implants.

Clinical Evidence

Clinical cases performed confirmed the safety and effectiveness of the device.

Technological Characteristics

System includes software for surgical planning and patient-specific hardware templates. Designed for use with specific Zimmer NEXGEN and Gender Solutions knee prosthesis families. Single-use hardware. Performance verified via non-clinical testing.

Indications for Use

Indicated for patients undergoing total knee replacement requiring assistance in component positioning and bone marking, provided anatomic landmarks are identifiable on MRI scans. Compatible with specific Zimmer NEXGEN and Gender Solutions knee prosthesis families. Single 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

• Zimmer Patient Specific Instrument System 2.0 (K093533)

Submission Summary (Full Text)

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KIII492( Vz)

# OCT 1 3 2011

# 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 | Alexandra Razzhivina |
| Contact title | Regulatory Officer |
| Contact e-mail address | [e-mail] |
| Additional contact person | Li Cher Chan |
| Contact title | Quality Responsible |
| Contact e-mail address | [e-mail] |
| Additional contact person | Karl vom Berge |
| Contact title | Product Manager |
| Contact e-mail address | [e-mail] |

### Submission date

The date of the Traditional 510(k) submission is May 27th, 2011.

### 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), MBH (21 CFR 888.3565) and OOG (21 CFR<br>888.3560) |

### Predicate device

| Predicate Device | |
|------------------------------------|-----------------------------------------------|
| Trade or proprietary or model name | Zimmer Patient Specific Instrument System 2.0 |
| 510(k) number | K093533 |
| Decision date | 17/02/2010 |
| Product code | JWH, MBH |
| Manufacturer | Materialise N.V. |

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### 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 NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN CR fixed bearing, Zimmer NEXGEN LPS-FLEX fixed bearing, Zimmer NEXGEN LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses.

#### 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 provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN CR fixed bearing, Zimmer NEXGEN LPS-FLEX fixed bearing, Zimmer NEXGEN LPS 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

Clinical cases performed confirmed the safety and effectiveness of the device.

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

Materialise NV % Ms. Alexandra Razzhivina Regulatory Officer Technologielaan 15 3001 Leuven Belgium

OCT 1 3 2011

Re: K111492

Trade/Device Name: The Zimmer Patient Specific Instruments System 2.5 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, MBH, OOG Dated: September 15, 2011 Received: September 19, 2011

Dear Ms. Razzhivina:

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.

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 issuunce 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 - Ms. Alexandra Razzhivina

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/CDRHQffices/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,

Euel Keith

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): K111492

Device Name: The Zimmer Patient Specific Instruments System 2.5

#### 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 provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN CR fixed bearing, Zimmer NEXGEN LPS-FLEX fixed bearing, Zimmer NEXGEN LPS 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)

Michael Olsen to MXM

ivision of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K111492