ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER

K112301 · Materialise NV · HSX · Jan 6, 2012 · Orthopedic

Device Facts

• Record ID: K112301
• Device Name: ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
• Applicant: Materialise NV
• Product Code: HSX · Orthopedic
• Decision Date: Jan 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• 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 Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone 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 Unicompartmental High Flex Knee System prostheses families only. The Zimmer Patient Specific Instruments are intended for single use only.

Device Story

System consists of Zimmer Patient Specific Instruments Planner (software) and Zimmer Patient Specific Instruments (hardware). Input: patient 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 intra-operatively to guide bone marking and cutting for unicompartmental knee replacement. Used in clinical setting by surgeons. Benefits: assists in accurate positioning and alignment of knee replacement components.

Clinical Evidence

No clinical data. Evidence consists of non-clinical laboratory testing, including software validation, saw bone models, cadaveric trials, and guide deformation verification after sterilization to assess safety and effectiveness.

Technological Characteristics

System comprises software (planner) and patient-specific hardware templates. Hardware is single-use. Connectivity involves processing of MRI imaging data. Software performs pre-surgical planning and template design. Sterilization is required for hardware components.

Indications for Use

Indicated for patients undergoing unicompartmental knee replacement requiring surgical assistance for component positioning, bone marking, and bone cutting, provided anatomic landmarks are identifiable on imaging scans. For use with Zimmer Unicompartmental High Flex Knee System prostheses only.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• Zimmer Unicompartmental Knee System (K033363)
• Signature™ Personalized Patient Care System (K110415)
• Zimmer Patient Specific Instrument System 2.0 (K093533)

Submission Summary (Full Text)

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KILZZOI(113)

JAN - 6 2012

# 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] |
| Principal contact person | 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 8th of August.

# Submission information

| Trade Name | Zimmer Patient Specific Instruments Planner<br>Zimmer Patient Specific Instruments |
|---------------------|------------------------------------------------------------------------------------|
| Common Name | Knee prosthesis |
| Classification Name | Knee joint femorotibial metal/polymer non-constrained<br>cemented prosthesis |
| Product code | HSX/OOG (21 CFR § 888.3520) |

# Predicate devices

| Predicate Device | |
|------------------------------------|-------------------------------------|
| Trade or proprietary or model name | Zimmer Unicompartmental Knee System |
| 510(k) number | K033363 |
| Decision date | 01/16/2004 |
| Product code | HSX |
| Manufacturer | Zimmer, INC. |

### Predicate Device

Signature™ Personalized Patient Care System Trade or proprietary or model name

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| 510(k) number | K110415 |
|---------------|------------------------|
| Decision date | 05/16/2011 |
| Product code | HRY, JWH/OIY, MBH, OOG |
| Manufacturer | Materialise N.V. |

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

### 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 unicompartmental knee replacement components for Unicompartmental High Flex Knee System prosthesis.

#### 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. 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 Unicompartmental Knee Replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual Unicompartmental Knee Replacement components by guiding and marking cut locations.

### Intended use

The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone 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 Unicompartmental High Flex Knee System 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 devices.

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# Performance data

### Non-clinical tests

Software validation and accuracy performance testing by means of saw bone models, cadaveric trials and guide deformation verification after sterilization were performed to assess the safety and effectiveness of the device.

These tests verified that the accuracy and performance of the device is adequate to perform as intended.

## Clinical data

Non-clinical laboratory testing was performed to determine substantial equivalence. Testing verified that the accuracy and performance of the device is adequate to perform as intended.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

JAN - 6 2012

Materialise N.V. % Ms. Alexandra Razzhivina 15 Technologielaan Leuven, 3001 Belgium

Re: K112301

Trade/Device Name: The Zimmer Patient Specific Instruments System 3.0 Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prothesis Regulatory Class: Class II Product Code: HSX, OOG Dated: December 16, 2011 Received: December 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. 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

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Page 2 – Ms. Alexandra Razzhivina

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,

. /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): K112301

Device Name: The Zimmer Patient Specific Instruments System 3.0

#### Indications for Use:

The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone 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 Unicompartmental High Flex Knee System prostheses families only.

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

Prescription Use × (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)

B.P. Ramilh for

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

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510(k) Number K112301