SIGNATURE PLANNER / SIGNATURE GUIDES

K110415 · Materialise NV · HRY · May 16, 2011 · Orthopedic

Device Facts

• Record ID: K110415
• Device Name: SIGNATURE PLANNER / SIGNATURE GUIDES
• Applicant: Materialise NV
• Product Code: HRY · Orthopedic
• Decision Date: May 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3530
• Device Class: Class 2

Intended Use

Signature™ Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ M Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, and AGC™ Complete Knee system. The Signature™ guides are intended for single use only.

Device Story

Signature™ Personalized Patient Care System comprises Signature™ Planner software and patient-specific Signature™ guides. System inputs are patient MRI imaging data. Surgeon uses Signature™ Planner to inspect, fine-tune, and approve a pre-surgical plan. Based on this plan, patient-specific guides are manufactured to transfer pre-operatively determined cut planes to the patient intra-operatively. Guides assist surgeon in positioning/aligning knee replacement components by marking drill/cut locations. Used in clinical settings by surgeons. Output is physical guide templates for single-use. Benefits include improved surgical accuracy and alignment for total/partial knee replacement procedures.

Clinical Evidence

No clinical data. Bench testing only, including cadaveric trials to verify system accuracy and guide deformation testing post-sterilization.

Technological Characteristics

System consists of software (Signature™ Planner) and patient-specific hardware (Signature™ guides). Guides are single-use. Software facilitates pre-surgical planning based on MRI data. No specific materials or energy sources described beyond standard surgical instrument classification.

Indications for Use

Indicated for patients undergoing total or partial knee replacement surgery where anatomic landmarks for implant alignment are identifiable on patient MRI scans. Contraindicated if necessary anatomic landmarks are not identifiable.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Signature™ Personalized Patient Care System (K102795)
• Patient Matched Cutting Blocks (K082358)

Submission Summary (Full Text)

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# 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 affairs officer |
| Contact e-mail address | [e-mail] |

### Submission date

The date of the Traditional 510(k) submission is 11th of February.

## Submission information

| Trade Name | Signature™ Planner<br>Signature™ guides |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Knee prosthesis |
| Classification Name | - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.<br>-Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis<br>- Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis |
| Product code | JWH/OIY (21 CFR § 888.3560), MBH (21 CFR § 888.3565),<br>HRY (21 CFR § 888.3530), OOG |

### Predicate devices

| Predicate Device | |
|------------------------------------|---------------------------------------------|
| Trade or proprietary or model name | Signature™ Personalized Patient Care System |
| 510(k) number | K102795 |
| Decision date | 02/02/2011 |
| Product code | JWH/OIY, MBH, OOG |
| Manufacturer | Materialise N.V. |

| 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. |

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#### Device Information

#### Description of the device

The Signature™ Personalized Patient Care System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the placement of Biomet total and partial knee replacement components.

#### Functioning of the device

The Signature™ Personalized Patient Care System generates a pre-surgical plan based on MRI imaging data using the Signature™ Planner (software component). The software is then used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the presurgical plan. Next, Signature™ guides are designed and manufactured based on the approved pre-surgical plan. Signature™ guides are patient specific templates that transfer the pre-operatively determined cut planes for positioning of the total and partial knee replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual total and partial knee replacement components by guiding and marking drill and/or cut locations.

#### Intended use

Signature™ Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ M Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, and AGC™ Complete Knee system.

The Signature™ guides 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.

#### Performance data

#### Non-clinical tests

The Signature"" Planner software has been validated for its intended use to determine substantial equivalence to the predicate devices.

Accuracy performance testing by means of cadaveric trials, and guide deformation verification after sterilization was performed to determine substantial equivalence. Testing

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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 -WO66-G609 Silver Spring, MD 20993-0002

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

MAY 16 2011

Re: K110415 Trade/Device Name: Signature guides™, Signature™ Planner Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY, JWH, OIY, MBH, OOG Dated: May 4, 2011 Received: May 6, 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 10 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. Iisting 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 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

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Page 2 - Ms. Alexandra Razzhivina

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 yours,

Aty B. Rh

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): K | 041 | کا

Device Name: The Signature™ Personalized Patient Care System (Signature™ guides, Signature™ Planner)

#### Indications for Use:

Signature™ Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Signature™ Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ M Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, and AGC™ Complete Knee system.

The Signature™ guides 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

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

510(k) Number K110415