MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES

K131559 · Materialise NV · KWS · Sep 27, 2013 · Orthopedic

Device Facts

• Record ID: K131559
• Device Name: MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
• Applicant: Materialise NV
• Product Code: KWS · Orthopedic
• Decision Date: Sep 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2

Indications for Use

The Match Point System™ is intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty procedures which utilize anatomic landmarks that are identifiable on preoperative CT or MRI medical images. The Match Point System™ can be used with the following total and reverse shoulder implant systems and their respective compatible components: Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and Reverse® Shoulder prosthesis (K092873). The Match Point System™ Guides are intended for single use only.

Device Story

Match Point System assists surgeons in glenoid component placement for shoulder arthroplasty. Input: preoperative CT or MRI medical images. SurgiCase Connect software allows surgeons to inspect, fine-tune, and approve a 3D preoperative plan featuring a virtual scapula model and implant/pin positioning. Output: patient-specific, single-use physical guide (baseplate with drill cylinder) manufactured based on the approved plan. Used in clinical settings by surgeons to transfer planned pin positioning intraoperatively. Benefits: improved accuracy of glenoid component placement via patient-specific templates.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via non-clinical bench testing, including accuracy performance testing in cadaveric settings and on rapid-prototyped models to verify guide positioning and system performance.

Technological Characteristics

Patient-specific surgical guides manufactured via rapid prototyping. System includes software (SurgiCase Connect) for 3D preoperative planning and physical guides (baseplate with drill cylinder) for intraoperative alignment. Connectivity: digital transfer of planning data. Sterilization: single-use device.

Indications for Use

Indicated for patients undergoing total or reverse shoulder arthroplasty requiring glenoid component positioning, where anatomic landmarks are identifiable via preoperative CT or MRI.

Regulatory Classification

Identification

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

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,” (vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Signature Personalized Patient Care System - Acetabular Guide System (K111863)

Reference Devices

• Encore Shoulder System (K051075)
• Turon™ Shoulder System (K080402)
• Turon™ to RSP Conversion Shell (K111629)
• Reverse® Shoulder prosthesis (K092873)

Submission Summary (Full Text)

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SEP 27 2013

# 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 | Mieke Janssen |
| Contact title | Director Quality and Regulatory Affairs |
| Contact e-mail address | [e-mail] |
| Additional contact person | Johan Ex |
| Contact title | Brand manager |
| Contact e-mail address | [e-mail] |

### Submission date

The date of the Traditional 510(k) submission is May 27th, 2013.

## Submission information

| Trade Name | Match Point System™, Match Point System™ guide, SurgiCase Connect |
|---------------------|-------------------------------------------------------------------------------------|
| Common Name | Patient specific instrumentation for shoulder arthroplasty |
| Classification Name | Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660) |
| Product codes | KWS |

## Predicate devices

| Trade or proprietary or model<br>name | Signature Personalized Patient Care System - Acetabular<br>Guide System | |
|---------------------------------------|-------------------------------------------------------------------------|--|
| 510(k) number | K111863 | |
| Decision date | 06/15/2012 | |
| Product codes | JDI, KWY, KWZ, LPH, LZO, MAY, MEH | |
| Manufacturer | Materialise NV | |

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| 510(k)<br>number | Decision<br>date | Product<br>code | Trade or proprietary<br>or model name | Manufacturer |
|------------------|------------------|-----------------|---------------------------------------|----------------------|
| K051075 | 05/27/2005 | KWS | Encore Shoulder<br>System | Encore Medical, L.P. |
| K080402 | 03/28/2008 | KWS | Turon™ Shoulder<br>System | Encore Medical, L.P. |
| K111629 | 09/16/2011 | KWS | Turon™ to RSP<br>Conversion Shell | Encore Medical, L.P. |
| K092873 | 10/27/2009 | KWS | Reverse® Shoulder<br>prosthesis | DJO Surgical |

Conventional instrumentation for shoulder arthroplasty (central drill guide) predicate:

### Device Information

### Description of the device

The Match Point System™ consists of a software component, SurgiCase Connect and a hardware component, Match Point System™ guide, and is designed to assist the surgeon in the placement of glenoid components.

The Match Point System is for use within the intended use of the compatible components.

### Functioning of the device

The Match Point System generates a preoperative plan based on medical imaging data using SurgiCase Connect, the software component. This software is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the preoperative plan. The preoperative plan displays a virtual 3D model of the patient's scapula, a glenoid implant for either reverse or total shoulder replacement positioned onto the glenoid surface, and the central pin which corresponds to the glenoid implant's position. The implant and pin are initially displayed in a default location according to the surgical technique of the respective implant system. The surgeon modifies the default position by rotating and translating the pin and implant Once the implant is in the desired position, the surgeon approves the orientation. preoperative plan.

Once approved, a Match Point System guides is designed and manufactured based on the preoperative plan. Match Point System guides are patient specific templates that transfer the preoperatively approved pin positioning to the patient intraoperatively. The guide consists of a patient specific baseplate which conforms to the patient's anatomy. The drill cylinder's position corresponds to the planned drill position. This drill cylinder's inner diameter matches the corresponding instrumentation's diameter. A Kirschner wire may be optionally used to help stabilize the guide's position while drilling.

### Intended use

The Match Point System™ is intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty procedures which utilize anatomic landmarks that are identifiable on preoperative CT or MRI medical images.

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The Match Point System™ can be used with the following total and reverse shoulder implant systems and their respective compatible components: Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and. Reverse® Shoulder prosthesis (K092873).

The Match Point System™ guides are intended for single use only.

#### Summary of technological characteristics

Device comparison analysis showed that the proposed device is substantially equivalent to the predicate devices in:

- design, intended use, functionality, technology, material and performance . characteristics for the Signature Personalized Patient Care System ~ Acetabular Guide System;
- intended use and functionality for the conventional instrumentation for shoulder . arthroplasty (central drill guide).

#### Performance data

#### Non-clinical tests

Accuracy performance testing was performed in a cadaveric setting to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended. Accuracy performance testing was performed on rapid prototyped models to verify guide use, positioning, and accuracy of the shoulder system at its borders for use.

#### Clinical data

Non-clinical testing was sufficient to demonstrate safety and effectiveness of the device as intended.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing or protecting another smaller figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 27, 2013

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

Re: K131559

Trade/Device Name: Match Point System™ (Match Point System™ Guides, SurgiCase Connect) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: K WS Dated: September 16, 2013 Received: September 18, 2013

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 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

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#### Page 2 - Ms. Alexandra Razzhivina

CFR Part 807); labeling (21 CFR Part 801); medical device 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 clectronic 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/McdicalDcvices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Mark N! Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K131559

## Indications for Use

KI 31559 510(k) Number (if known): นทหาอพก

Device Name: Match Point System™ (Match Point System™ Guides, SurgiCase Connect)

Indications for Use:

The Match Point System™ is intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty procedures which utilize anatomic landmarks that are identifiable on preoperative CT or MRI medical images.

The Match Point System™ can be used with the following total and reverse shoulder implant systems and their respective compatible components: Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and Reverse® Shoulder prosthesis (K092873).

The Match Point System™ Guides are intended for single use only.

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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)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices