SIGNATURE PLANNER; SIGNATURE GUIDES

K102795 · Materialise NV · JWH · Feb 2, 2011 · Orthopedic

Device Facts

• Record ID: K102795
• Device Name: SIGNATURE PLANNER; SIGNATURE GUIDES
• Applicant: Materialise NV
• Product Code: JWH · Orthopedic
• Decision Date: Feb 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• 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 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 Signature Personalized Patient Care System can be used with the following Biomet knee systems and their respective components: Vanguard® Complete 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

System comprises Signature™ Planner software and patient-specific Signature™ guides. Input: patient MRI or CT imaging data. Process: software generates pre-surgical plan; surgeon inspects, fine-tunes, and approves plan; guides manufactured based on approved plan. Output: patient-specific templates used intra-operatively to transfer pre-determined pin locations to patient bone for positioning cutting blocks. Used in clinical setting by orthopedic surgeons. Benefits: assists in accurate positioning of total knee replacement components.

Clinical Evidence

No clinical data. Performance validated via non-clinical cadaveric trials and guide deformation verification after sterilization.

Technological Characteristics

System includes software (Signature™ Planner) and patient-specific hardware (Signature™ guides). Guides are patient-specific templates. Software matches device to patient anatomy using MRI/CT data. Single-use guides.

Indications for Use

Indicated for patients undergoing total knee replacement surgery where anatomic landmarks for implant alignment are identifiable on MRI or CT scans.

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

• SurgiCase (K073449)
• Zimmer Patient Specific Instruments System 2.0 (K093533)

Submission Summary (Full Text)

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K102795 (1/3)

FEB - 2 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 affairs officer |
| Contact e-mail address | [e-mail] |

# Submission date

The date of the Traditional 510(k) submission is 24th September 2010.

# Submission information

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

# Predicate devices

| Predicate Device | |
|------------------------------------|------------------|
| Trade or proprietary or model name | SurgiCase |
| 510(k) number | K073449 |
| Decision date | 04/16/2008 |
| Product code | LLZ |
| Manufacturer | Materialise N.V. |

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| Predicate Device | |
|------------------------------------|---------------------------------------------------|
| Trade or proprietary or model name | Zimmer Patient Specific Instruments<br>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

Signature тм 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 total knee replacement components.

### Functioning of the device

Signature ти Personalized Patient Care System generates a pre-surgical plan based on MRI or CT imaging data using the Signature™ Planner (software component). The software is then used preoperatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical 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 pin locations for positioning of the total knee replacement components to the patient intra-operatively. The surgical guides are used to accurately place the guide pins used to position the cutting blocks.

#### Intended use

Signature™ Personalized Patient Care 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 Signature Personalized Patient Care System can be used with the following Biomet knee systems and their respective components: Vanguard® Complete 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 to the predicate devices, in that the device materials are identical to the predicate; and, like the predicate device, the subject device is matched to the patient using software.

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# 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 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

# FEB - 2 2011

Re: K102795

Trade/Device Name: Signature™ Personalized Patient Care System (Signature™ Guides, Signature™ Planner) 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, OIY, MBH, OOG Dated: December 23, 2010 Received: December 27, 2010

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 indivions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate 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 I.c. The general controls provisions of the Act include requirements for annual registration, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you; however, that device labeling must be truthful and not michery

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 (1 h 1 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 - Ms. Alexandra Razzhivina

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 liusing (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 economic 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/ucm1118001/jp/dfast 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" (215FR Paul 807.97). For questions regarding the reporting of adverse events under the MIR 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-freen mber [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

A.j. B. rita
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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#### 510(k) Number K102795:

Device Name: 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 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 Signature™ Personalized Patient Care System can be used with the following Biomet knee systems and their respective components: Vanguard® Complete 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 _ AND/OR Over-The-Counter Use _____________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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)

Ar. M. Melkersm
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ical, Orthopedic, Division of Surg and Restorative Devices

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