Materialise Glenoid Positioning System

K172054 · Materialise NV · KWS · Nov 3, 2017 · Orthopedic

Device Facts

• Record ID: K172054
• Device Name: Materialise Glenoid Positioning System
• Applicant: Materialise NV
• Product Code: KWS · Orthopedic
• Decision Date: Nov 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2

Intended Use

The Materialise Glenoid Positioning 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 by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Materialise Glenoid Positioning System can be used in conjunction with Stryker's ReUnion RSA Reverse Shoulder System (K130895) and its respective components, with DJO's following total and reverse shoulder implant systems and their respective compatible components: the Reverse® Shoulder Prosthesis (K051075, K111629, K092873, K112069), the Turon® Shoulder System (K080402, K123982), and the AltiVate™ Anatomic Shoulder System (K162024), and Lima's SMR Shoulder System (K100858), SMR Reverse Shoulder System (K110598), SMR Modular Glenoid (K113254), SMR 3-Pegs Glenoid (K130642), SMR TT Metal Back Glenoid (K133349), SMR 40mm Glenosphere (K142139) and SMR Modular Glenoid (K143256) and their respective components and Depuy Synthes' GLOBAL® APG+ Shoulder System (K052472), the DELTA XTEND™ Reverse Shoulder System (K120174, K062250) and the GLOBAL® STEPTECH® APG Shoulder System (K092122) and their respective components. The Materialise Glenoid Positioning System guide is single use only. Surgicase Planner is intended to be used as a pre-surgical planner for surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of glenoid components. SurgiCase Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Glenoid Positioning Guide.

Device Story

System comprises SurgiCase Planner software and patient-specific hardware guides; inputs preoperative CT-imaging scans; software enables visualization, measurement, reconstruction, annotation, and editing of shoulder anatomy to generate pre-surgical plan; surgeon inspects/approves plan; if requested, patient-specific guide manufactured to transfer plan to surgery; guide used intraoperatively by orthopedic surgeon to position glenoid components; benefits include improved surgical accuracy and alignment; system supports various third-party shoulder implant systems.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility, cleaning, debris, and dimensional stability. Accuracy and performance verified; stability of device placement and surgical technique validated via reference to previously cleared devices (K153602, K131559) and associated cadaver testing.

Technological Characteristics

System includes patient-specific hardware guides and SurgiCase Planner software. Guides are single-use, patient-specific templates. Software provides 3D reconstruction and planning. Manufacturing complies with FDA 21 CFR 820/Part 11 and ISO 9000/13485. Connectivity involves processing preoperative CT-imaging data.

Indications for Use

Indicated for patients undergoing total or reverse shoulder arthroplasty requiring assistance in intraoperative glenoid component positioning via patient-specific guides derived from preoperative CT scans.

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

• Materialise Glenoid Positioning System (K170893)

Reference Devices

• BLUEPRINT™ Patient Specific Instrumentation (K162800)
• Materialise Glenoid Positioning System (K153602)
• Materialise Glenoid Positioning System (K131559)

Submission Summary (Full Text)

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November 3, 2017

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Materialise NV Oliver Clemens Regulatory Officer, Medical Technologielaan 15 Leuven, 3001 Belgium

Re: K172054

Trade/Device Name: Materialise Glenoid Positioning System Regulation Number: 21 CFR 888,3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS Dated: August 7, 2017 Received: August 7, 2017

Dear Oliver Clemens:

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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Katherine D. Kavlock -C

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

Enclosure

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# Indications for Use

510(k) Number (if known) K172054

Device Name Materialise Glenoid Positioning System

Indications for Use (Describe) Hardware

The Materialise Glenoid Positioning 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 by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.

The Materialise Glenoid Positioning System can be used in conjunction with Stryker's ReUnion RSA Reverse Shoulder System (K130895) and its respective components, with DJO's following total and reverse shoulder implant systems and their respective compatible components: the Reverse® Shoulder Prosthesis (K051075, K111629, K092873, K112069), the Turon® Shoulder System (K080402, K123982), and the AltiVate™ Anatomic Shoulder System (K162024), and Lima's SMR Shoulder System (K100858), SMR Reverse Shoulder System (K110598), SMR Modular Glenoid (K113254), SMR 3-Pegs Glenoid (K130642), SMR TT Metal Back Glenoid (K133349), SMR 40mm Glenosphere (K142139) and SMR Modular Glenoid (K143256) and their respective components and Depuy Synthes' GLOBAL® APG+ Shoulder System (K052472), the DELTA XTEND™ Reverse Shoulder System (K120174, K062250) and the GLOBAL® STEPTECH® APG Shoulder System (K092122) and their respective components. The Materialise Glenoid Positioning System guide is single use only.

Software

Surgicase Planner is intended to be used as a pre-surgical planner for surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of glenoid components. SurgiCase Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Glenoid Positioning Guide.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

## 510(k) Summary

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92

| 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 | Oliver Clemens |
| Contact title | Regulatory Officer |
| Contact e-mail address | [e-mail] |
| Additional contact person | Filip Jonkergouw |
| Contact title | Product Manager |
| Contact e-mail address | [e-mail] |

## Submission date

The date of the Traditional 510(k) submission is July 4, 2017

## Submission information

| Trade Name | Materialise Glenoid Positioning System |
|----------------------|--------------------------------------------------------------------------------------|
| Common Name | Patient specific instrumentation for shoulder arthroplasty + 3D<br>planning software |
| Classification Name | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer<br>Cemented |
| Primary product code | KWS (21 CFR 888.3660) |

## Predicate Device

The predicate device to which substantial equivalence is claimed:

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| Trade or proprietary or model name | Materialise Glenoid Positioning System<br>Materialise Glenoid Positioning System guide<br>SurgiCase Planner |
|------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 510(k) number | K170893 |
| Decision date | June 19, 2017 |
| Classification product code | KWS (21 CFR 888.3660) |
| Manufacturer | Materialise N.V. |

## Reference device

| Trade or proprietary or model name | BLUEPRINT™ Patient Specific Instrumentation |
|------------------------------------|---------------------------------------------|
| 510(k) number | K162800 |
| Decision date | February 22, 2017 |
| Classification product code | KWS (21 CFR 888.3660) |
| Manufacturer | Tornier SAS |

## Device Description

Materialise Glenoid Positioning Guides are patient-specific medical devices that are designed to assist the surgeon in the placement of glenoid components.

This can be done by generating a pre-surgical plan or by generating a pre-surgical plan and manufacturing patientspecific guides to transfer the plan to surgery. The device is a system composed of the following:

- . a software component, branded as SurgiCase Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient.
- a hardware component, branded as the Materialise Glenoid Positioning System™ guide, which is a patient specific guide that is based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guides will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery. The guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Glenoid Positioning System guide. A graft model can be delivered with the Materialise Glenoid Positioning System guide.

The Materialise Glenoid Positioning Guides must only be used within the intended use of the compatible components.

## Intended Use

Materialise N.V.

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#### 510(k) Summary

#### Hardware

The Materialise Glenoid Positioning 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 by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.

The Materialise Glenoid Positioning System can be used in conjunction with Stryker's ReUnion RSA Reverse Shoulder System (K130895) and its respective components, with DJO's following total and reverse shoulder implant systems and their respective components: the Reverse® Shoulder Prosthesis (K051075, K111629, K092873, K112069), the Turon® Shoulder System (K080402, K123982), and the AltiVate™ Anatomic Shoulder System (K162024), and Lima's SMR Shoulder System (K100858), SMR Reverse Shoulder System (K110598), SMR Modular Glenoid (K113254), SMR 3-Pegs Glenoid (K130642), SMR TT Metal Back Glenoid (K133349), SMR 40mm Glenosphere (K142139) and SMR Modular Glenoid (K143256) and their respective components and Depuy Synthes' GLOBAL® APG+ Shoulder System (K052472), the DELTA XTEND™ Reverse Shoulder System (K120174, K062250) and the GLOBAL® STEPTECH® APG Shoulder System (K092122) and their respective components.

The Materialise Glenoid Positioning System guide is single use only.

#### Software

Surgicase Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of glenoid components. SurgiCase Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Glenoid Positioning Guide.

## Functioning of the Device

The Materialise Glenoid Positioning System generates a pre-surgical imaging data using the SurgiCase Planner. The software device then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. If requested by the surgeon, Materialise Glenoid Positioning System guides are designed and manufactured based on the approved pre-surgical plan. Materialise Glenoid Positioning System guides are patient specific templates which transfer the pre-operatively determined pin positioning to the patient intraoperatively, assisting the surgeon in positioning glenoid components used with total and reverse shoulder arthroplasty procedures.

#### Technological Characteristics

A detailed comparison shows the subject device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics to the predicate device, however extends the functionality of the SurgiCase Planner to include showing of DICOM images, graft model visualization and a humerus visualization with subluxation index.

#### Performance Data

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## 510(k) Summary

Previous testing for biocompatibility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. The stability of the device placement, surgical technique, intended use and functional elements of the same as that of the predicate Materialise Glenoid Positioning System K170893 and previously cleared devices K153602 and K131559, and therefore previous cadaver testing on previously cleared devices K153602 and K131559 is considered applicable to the subject device.

## Summary

The characteristics that determine the functionality and performance of the subject device are substantially equivalent to the predicate device cleared under K153602. The non-clinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicates. The Materialise Glenoid Positioning System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (9000 and 13485) requirements.