SIGNATURE PLANNER,SIGNATURE GUIDES

K111863 · Materialise NV · JDI · Jun 15, 2012 · Orthopedic

Device Facts

• Record ID: K111863
• Device Name: SIGNATURE PLANNER,SIGNATURE GUIDES
• Applicant: Materialise NV
• Product Code: JDI · Orthopedic
• Decision Date: Jun 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2

Intended Use

The Signature™ Personalized Patient Care System - Acetabular Guide System is intended to be used as a surgical instrument to assist in the orientation of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative MRI imaging scans. The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with all Biomet 510(k) cleared, legally marketed, primary acetabular systems and their respective components. The Signature™ guides are intended for single use only.

Device Story

System comprises Signature™ Planner software and patient-specific Signature™ guides; assists surgeons in acetabular cup orientation during hip arthroplasty. Input: preoperative MRI imaging data. Process: software generates pre-surgical plan; surgeon inspects/approves plan; guides manufactured based on plan. Intraoperative use: primary guide places two pins near acetabular rim; secondary guide attaches to pins to establish cup orientation via alignment pin. Optional alignment pin adaptor on cup inserter handle uses magnets to ensure parallel alignment with pin. Output: physical templates for precise implant positioning. Benefits: improved accuracy of cup orientation relative to preoperative plan. Used in clinical/OR settings by orthopedic surgeons.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including accuracy performance testing and guide dimensional stability testing.

Technological Characteristics

System includes software (Signature™ Planner) and patient-specific hardware (Signature™ guides). Guides are single-use. Connectivity involves preoperative MRI data processing. No specific material standards or algorithm architecture details provided beyond patient-specific template manufacturing.

Indications for Use

Indicated for use as a surgical instrument to assist in the orientation of acetabular cup components during hip replacement surgery. Utilizes anatomical landmarks of the pelvis identifiable on preoperative MRI scans. Compatible with all Biomet 510(k) cleared primary acetabular systems. For prescription use only.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• SurgiCase (K073449)
• Signature™ Personalized Patient Care System (K102795)
• Acumen Surgical Navigation System (K031454)
• Instrument (510(k) exempt (888.4540))

Submission Summary (Full Text)

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JUN 1 5 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] |
| Contact name | Alexandra Razzhivina |
| Contact title | Regulatory Officer |
| Contact e-mail address | [e-mail] |

# Submission date

The date of the Traditional 510(k) submission is 28th June, 2011.

# Submission information

| Trade Name | Signature™ Planner<br>Signature™ guides |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Hip prosthesis |
| Classification Name | - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented<br>- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented<br>- Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer<br>- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented<br>- Prosthesis, Hip, Hemi-Femoral, Metal/Polymer, Cemented or Uncemented<br>- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous Cemented, Osteophilic Finish<br>- Prosthesis, Hip, Semi-constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate |
| Primary product codes | LPH |
| Secondary product codes | LZO, KWZ, JDI, KWY, MAY, MEH |

# 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 | 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 | Acumen Surgical Navigation System |
| 510(k) number | K031454 |
| Decision date | 07/08/2004 |
| Product code | HAW |
| Manufacturer | Biomet Manufacturing |
| Predicate Device | |
| Trade or proprietary or model name | Instrument |
| 510(k) number | 510(k) exempt (888.4540) |
| Decision date | NA |
| Product code | KIL |
| Manufacturer | Biomet Manufacturing |

## Device Information

### Description of the device

The Acetabular Guide System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the orientation of an acetabular cup.

The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with the following Biomet acetabular systems and their respective compatible components: Bio-Clad™ All-Poly Cup (K810120 and K926107), Ranawat/Burstein™ All-Poly Cup (preamendment), RX-90™ Low Profile Shell (K920639 and K042989), Full Hemisphere Shell (K920640), Mallory/Head™ Shells (K861114, K921181, and K030055), Quadrant Sparing Shells (K920640 and K050124), Ranawat/Burstein™ Shells (K911685, K921277, and K050124), Regenerex™ Porous Titanium Shells (K052996), Regenerex™ Ringloc+ Shell System (K070369), Ringloc+ Acetabular System (K070369), Tri-Spike Pegged Shells (K970501 and K030055), Tri-Polar Shell (K991990), Universal Shells (K861433, K921301, and K030055), Vision™ Shells (K954417 and K030055), Freedom™ Constrained All-Poly Cups (K030047), M2a-Magnum™ with E1™ Active Articulation (K101336), and M2a-Magnum™ with ArComXL™ Active Articulation (K110555).

### Functioning of the device

The Acetabular Guide 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 pre-surgical plan. Next,

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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 and the planned acetabular cup orientation to the patient intraoperatively. The first surgical guide (Primary Acetabular Guide) is used to place two pins near the acetabular rim. A second surgical guide (Secondary Acetabular Guide) is then assembled to these pins and is used to recreate the pre-operatively determined acetabular cup orientation by positioning an alignment pin parallel to the planned cup insertion location. The surgeon may then place the acetabular cup implant in the pre-operatively determined location by aligning the inserter handle with the alignment pin held by the secondary acetabular guide. The alignment pin adaptor, an optional accessory, attaches to the cup inserter handle and interfaces with the alignment pin using a slot and a series of magnets. This orients the cup inserter handle parallel to the alignment pin during insertion of the acetabular cup.

#### Intended use

The Signature™ Personalized Patient Care System - Acetabular Guide System is intended to be used as a surgical instrument to assist in the orientation of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative MRI imaging scans.

The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with all Biomet 510(k) cleared, legally marketed, primary acetabular systems and their respective components.

. 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

Accuracy performance testing and guide dimensional stability testing 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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JUN 1 5 2012

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

Materialise N.V. Yo Ms. Alaxandra Razzhivina 15 Technologielaan Leuven, Belgium 3001

Re: K111863

Trade/Device Name: Signature Planner, Signature Guides Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, KWZ, JDI, KWY, MAY, MEH Dated: June 05, 2012 Received: June 07, 2012

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 r house of as note a determination that your device complies with other requirements of the Act

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Page 2 – Ms. Alaxandra 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 A. Milliken

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): K111863

Signature™ Personalized Patient Care System - Acetabular Guide System Device Name: (Signature™ Guides, Signature™ Planner)

#### Indications for Use:

The Signature™ Personalized Patient Care System – Acetabular Guide System is intended to be used as a surgical instrument to assist in the orientation of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative MRI imaging scans.

The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with all Biomet 510(k) cleared, legally marketed, primary acetabular systems and their respective components.

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)

s

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

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