(181 days)
K052472, K120174, K062250, K183077, K203694, K092122, K202716, K212737, K051075, K111629, K092873, K080402, K162024, K100448, K112438, K142413, K152047, K130050, K161189, K173717, K181999, K100858, K110598, K113254, K143256, K130642, K133349, K142139, K183039, K190286, K172054, K170893, K153602, K131559
No
The summary describes a software planning tool and patient-specific guides/models based on the surgeon's plan, with no mention of AI or ML.
No.
The device is a surgical instrument intended to assist in the intraoperative positioning of glenoid components during shoulder arthroplasty, and a pre-surgical planning software. It does not directly provide therapy.
No
The device is described as a surgical instrument and a patient-specific guide used to assist in the intraoperative positioning of glenoid components during shoulder arthroplasty, and a pre-surgical planning tool. Its primary function is to aid in surgical procedures, not to diagnose medical conditions.
No
The device description explicitly states that the system is composed of both a software component (SurgiCase Shoulder Planner) and physical 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:
- Intended Use: The intended use clearly states that the device is a "surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty". This describes a device used during surgery on a patient's body, not a device used to examine specimens outside of the body.
- Device Description: The device is described as 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 further reinforces its use in a surgical setting.
- Anatomical Site: The anatomical site is the "shoulder", indicating a part of the human body.
- Intended User / Care Setting: The intended user is a "qualified surgeon" and the care setting is "intra-operatively, OR". This confirms its use in a surgical environment.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such functions. It is a surgical planning and guidance tool used directly on the patient during surgery.
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:
- · Depuy Synthes'
- DJO's
- Smith & Nephew's2
- · Lima'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.
Product codes
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 quide 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 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
CT-imaging scans.
Anatomical Site
Shoulder, Glenoid, Scapula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, intraoperative, pre-surgical planner
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™ K212569 and previously cleared devices 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)
Reference Device(s)
K052472, K120174, K062250, K183077, K203694, K092122, K202716, K212737, K051075, K111629, K092873, K080402, K162024, K100448, K112438, K142413, K152047, K130050, K161189, K173717, K181999, K100858, K110598, K113254, K143256, K130642, K133349, K142139, K183039, K190286, K172054, K170893, K153602, K131559
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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August 17, 2022
Materialise NV Jenny Jones Global Quality and Regulatory Manager Technologielaan 15 Leuven, 3001 Belgium
Re: K220452
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: July 18, 2022 Received: July 18, 2022
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 (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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
For Victoria Lilling, M.D. Assistant Division Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220452
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:
- · Depuy Synthes'
- DJO's
- Smith & Nephew's2
- · Lima'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.
2The 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.
'The implant system was originally cleared under K202716 as the Ignite Anatomic Shoulder System and was rebranded by Depuy Synthes as INHANCETM Anatomic Shoulder System.
3
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 name | Materialise N.V. |
|---|---|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | +32 16 39 66 11 |
| Fax number | +32 16 39 66 06 |
| Primary contact person | Jenny Jones |
| Phone number | 734-259-7017 |
| Contact title | Global Quality Regulatory Manager |
| Contact e-mail address | Regulatory.Affairs@materialise.be |
| Additional contact person | Nele Daemen |
| Contact title | Technical product manager |
| Contact e-mail address | Nele.Daemen@materialise.be |
Submission date
The date of the Traditional 510(k) submission is February 16, 2022.
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 | Prosthesis, Shoulder, Semi-Constrained,
Metal/Polymer Cemented |
| Primary product code | QHE (21 CFR 888.3660) |
| Additional product codes | KWS (21 CFR 888.3660)
PHX (21 CFR 888.3660) |
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 | K212569 |
| Decision date | January 12, 2022 |
5
| 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 quide 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 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. 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:
- Depuv Synthes'
6
- INHANCE™ Anatomic Shoulder System (K202716)¹ o
- INHANCE™ Reverse Shoulder System (K212737) o
- DJO's ●
- Smith & Nephew's 2 ●
- K181999)
●
- Lima's
- SMR™ Shoulder System (K100858) O
- SMR™ Reverse Shoulder System (K110598) O
- SMR™ Modular Glenoid (K113254) (K143256) o
- SMR™ 3-Pegs Glenoid (K130642) O
- SMR™ TT Metal Back Glenoid (K133349) O
- SMR™ 40mm Glenosphere (K142139) o
- 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 presurgical plan data file which can be used as input data to design the Materialise Shoulder Guide and Models.
1The implant system was originally cleared under K202716 as the Ignite Anatomic Shoulder System and was rebranded by Depuy Synthes as INHANCE™ Anatomic Shoulder System. ²The 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 SurqiCase 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 (SCSP) 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 presurgical plan. Materialise Shoulder Guide and Models are patient specific templates which transfer the pre-operatively determined pin positioning to the patient intra-operatively 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:
7
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
. 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 K212569 is the addition of the following Depuy Synthes' components in the software component of the subject device for the surgeon to select during the planning stage:
- INHANCE™ Reverse Shoulder System (K212737) o
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 Depuy Synthes' Implant components:
INHANCE™ Reverse Shoulder System (K212737) о
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™ K212569 and previously cleared devices 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.
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.