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K Number
K233408
Device Name
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
Manufacturer
Materialise N.V.
Date Cleared
2023-11-09

(34 days)

Product Code
QHEKWSPHX
Regulation Number
888.3660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hardware: The Materialise Shoulder Guide and Models are 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 Shoulder Guide and Models are single use only. The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components: DePuy Synthes', Enovis' (DJO), Smith+Nephew's, Lima's, Stryker's. Software: SurgiCase Shoulder 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 shoulder components. SurgiCase Shoulder 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 Shoulder Guide and Models.
Device Description
Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following: a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient. Materialise Shoulder Guide and Models, which are a patient-specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific glenoid guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.
More Information

K231112

K052472, K120174, K062250, K183077, K203694, K092122, K202716, K212737, K051075, K111629, K092873, K080402, K162024, K213387, K100448, K112438, K142413, K152047, K130050, K161189, K173717, K181999, K220847, K230572, K100858, K110598, K113254, K143256, K130642, K133349, K142139, K220792, K183039, K220452, K212569, K193560, K190286, K172054, K170893, K153602, K131559

No
The summary describes software for pre-surgical planning and patient-specific guides based on that plan. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The software functions described are visualization, measurement, reconstruction, annotation, and editing, which are typical of traditional medical imaging software.

No.
The device is a surgical guide and planning software designed to assist surgeons in positioning glenoid components during shoulder arthroplasty, not to provide therapy itself.

No

Explanation: The device is intended for pre-surgical planning and intraoperative guidance for positioning glenoid components in shoulder arthroplasty, not for diagnosing a medical condition.

No

The device is described as a system composed of both a software component (SurgiCase Shoulder Planner) and hardware components (Materialise Shoulder Guide and Models), which are patient-specific guides and models.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
  • Intended Use/Indications for Use: The intended use of the Materialise Shoulder System is to assist in the intraoperative positioning of glenoid components during shoulder surgery and for pre-surgical planning. This involves using the device during a surgical procedure or for planning before a surgical procedure.
  • Device Description: The device description clearly states that the system is a patient-specific medical device designed to assist the surgeon in the placement of shoulder components during surgery. It involves software for planning and physical guides and models used in the operating room.
  • Lack of Mention of In Vitro Testing: There is no mention of the device being used to test samples from the body or to perform any diagnostic tests on biological specimens.

The Materialise Shoulder System is a surgical planning and guidance system, which falls under the category of surgical instruments and planning software, not in vitro diagnostics.

N/A

Intended Use / Indications for Use

Hardware

The Materialise Shoulder Guide and Models are 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 Shoulder Guide and Models are single use only.

The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components:

Software

SurgiCase Shoulder 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 shoulder components. SurgiCase Shoulder 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 Shoulder Guide and Models.

Product codes (comma separated list FDA assigned to the subject device)

QHE, KWS, PHX

Device Description

Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following:

  • . a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient.
  • Materialise Shoulder Guide and Models, which are a patient-specific guide and models that are based ● on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patientspecific glenoid quide and models will be manufactured if the surqeon requests patient-specific quides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

preoperative CT-imaging scans

Anatomical Site

shoulder

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgeon, OR

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Hardware:
Previous testing for biocompatibility, sterility, 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 subject device are the same as that of the predicate device of Materialise Shoulder System™ K231112 and previously cleared devices K220452, K212569, K193560, K190286, K172054, K170893, K153602 and K131559, and therefore previous simulated surgeries using rapid prototyped bone models and previous cadaver testing on previously cleared devices K153602 and K131559 are considered applicable to the subject device.

Software:
Software verification and validation were performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This includes verification against defined requirements, and validation against user needs.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K231112

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K052472, K120174, K062250, K183077, K203694, K092122, K202716, K212737, K051075, K111629, K092873, K080402, K162024, K213387, K100448, K112438, K142413, K152047, K130050, K161189, K173717, K181999, K220847, K230572, K100858, K110598, K113254, K143256, K130642, K133349, K142139, K220792, K183039, K220452, K212569, K193560, K190286, K172054, K170893, K153602, K131559

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
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.”

0

November 9, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Materialise N.V. Jenny Jones Global Quality Regulatory Manager Technologielaan 15 Leuven, 3001 Belgium

Re: K233408

Trade/Device Name: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHE, KWS, PHX Dated: October 5, 2023 Received: October 6, 2023

Dear Jenny Jones:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Joseph P. Joseph P. Russell -S Russell -S Date: 2023.11.09 15:32:08 -05'00'

for: Farzana Sharmin, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

Submission Number (if known)

K233408

Device Name

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

Indications for Use (Describe)

Hardware

The Materialise Shoulder Guide and Models are 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 Shoulder Guide and Models are single use only.

The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components:

Software

SurgiCase Shoulder 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 shoulder components. SurgiCase Shoulder Planner allows the surgeon to visualize,

3

measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation i of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Shoulder Guide and Models.

1 The implant system was originally cleared under K202716 as the Ignite Anatomic Shoulder System and was rebranded by DePuy Synthes as INHANCE™ Anatomic Shoulder System. 2DJO company name changed to Enovis. The shoulder products of Enovis were originally cleared under the company name of DJO (Encore Medical).

3The Integra shoulder portfolio was acquired by Smith+Nephew in 2020. The shoulder products of the Titan™ Shoulder System were transferred from Integra to Smith+Nephew.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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4

510(k) Summary

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92.18

Company nameMaterialise N.V.
Establishment registration number3003998208
Street AddressTechnologielaan 15
CityLeuven
Postal code3001
CountryBelgium
Phone number+32 16 39 66 11
Fax number+32 16 39 66 06
Primary contact personGiulia Girola
Phone number+39 3285339108
Contact titleRegulatory Affairs Specialist
Contact e-mail addressRegulatory.Affairs@materialise.be
Additional contact personJenny Jones
Contact titleGlobal Quality Regulatory Manager
Contact e-mail addressJenny.Jones@materialise.com

Submission date

The date of the Special 510(k) submission is October 6, 2023.

Submission Information

| Trade Name | Materialise Shoulder System™
Materialise Shoulder Guide and Models
SurgiCase Shoulder Planner |
|--------------------------|-----------------------------------------------------------------------------------------------------|
| Common Name | Patient specific instrumentation for shoulder
arthroplasty + 3D planning software |
| Classification Name | Shoulder joint metal/polymer semi-
constrained cemented prosthesis. |
| Primary product code | QHE (21 CFR 888.3660) |
| Additional product codes | KWS (21 CFR 888.3660)
PHX (21 CFR 888.3660) |

5

Predicate Device

The predicate device to which substantial equivalence is claimed:

| Trade or proprietary or model name | Materialise Shoulder System™
Materialise Shoulder Guide and Models
SurgiCase Shoulder Planner |
|------------------------------------|-----------------------------------------------------------------------------------------------------|
| 510(k) number | K231112 |
| Decision date | September 12, 2023 |
| Classification product code | QHE (21 CFR 888.3660)
KWS (21 CFR 888.3660)
PHX (21 CFR 888.3660) |
| Manufacturer | Materialise N.V. |

Device Description

Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following:

  • . a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient.
  • Materialise Shoulder Guide and Models, which are a patient-specific guide and models that are based ● on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patientspecific glenoid quide and models will be manufactured if the surqeon requests patient-specific quides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.

Indications for Use

Hardware

The Materialise Shoulder Guide are 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 Shoulder Guide and Models are single use only.

6

The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components:

DePuy Synthes' ●

. Smith+Nephew's3

7

  • Reunion TSA Total Shoulder Arthroplasty System (K183039)

Software

SurgiCase Shoulder 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 shoulder components. SurgiCase Shoulder 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 presurgical plan data file which can be used as input data to design the Materialise Shoulder Guide and Models.

1 The implant system was originally cleared under K202716 as the Ignite Anatomic Shoulder System and was rebranded by DePuy Synthes as INHANCE™ Anatomic Shoulder System. 2DJO company name changed to Enovis. The shoulder products of Enovis were originally cleared under the company name of DJO (Encore Medical).

3 The Integra shoulder portfolio was acquired by Smith+Nephew in 2020. The shoulder products of the Titan™ Shoulder System were transferred from Integra to Smith+Nephew.

Functioning of the Device

The Materialise Shoulder System™ generates a pre-surgical plan based on medical imaging data using the SurgiCase Shoulder Planner. The SurgiCase Shoulder Planner allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data, which leads to the generation of a case planning report. The SurgiCase Shoulder Planner allows for the creation of a glenoid and/or humeral pre-operative plan. If requested by the surgeon, Materialise Shoulder Guide and Models are designed and manufactured based on the approved glenoid pre-surgical plan. Materialise Shoulder Guide and Models 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. The Materialise Shoulder Guide and Models are available for glenoid components only.

Technological Characteristics

The Materialise Shoulder System™ has an equivalent intended use and the same fundamental scientific technology as the predicate device. The subject device's software is intended for positioning shoulder components, i.e. glenoid components and humeral components (same as the predicate device). The subject device's hardware is intended for positioning shoulder glenoid components only (same as the predicate device).

Software

The subject software device employs similar fundamental technologies as the predicate software device. Technological similarities include:

  • Device functionality: The planning functionality, visualization options and planning features are the same for the glenoid planning of the subject device as for the predicate device.

8

  • Software technology: The subject device has the same code base as the predicate device and ● uses the same methods for design and verification and validation as the predicate device.
    Following technological differences exist between the subject device software and the predicate device software:

  • . The main difference between the subject device and previously cleared predicate device K231112 is the addition of the following Smith+Nephew's' component in the software component of the subject device for the surgeon to select during the planning stage:

The subject software technology differences have been demonstrated that they do not affect the safety or effectiveness, or that they do not raise any new issues regarding to the safety and effectiveness compared to the predicate device.

Hardware

The subject hardware device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics compared with the predicate device.

The main difference between the subject device hardware and the predicate device is the extension of compatibility of the SurgiCase Shoulder Guides and Models with additional Smith+Nephew's' implant component:

Performance Data (non-clinical)

Hardware:

Previous testing for biocompatibility, sterility, 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 subject device are the same as that of the predicate device of Materialise Shoulder System™ K231112 and previously cleared devices K220452, K212569, K193560, K190286, K172054, K170893, K153602 and K131559, and therefore previous simulated surgeries using rapid prototyped bone models and previous cadaver testing on previously cleared devices K153602 and K131559 are considered applicable to the subject device.

Software:

Software verification and validation were performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This includes verification against defined requirements, and validation against user needs.

9

Conclusion

The non-clinical performance testing indicates that the subject device is as safe and effective as the predicate device. Therefore, it can be concluded that the Materialise Shoulder System™ is substantially equivalent to the predicate device.