(90 days)
Not Found
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the system as performing pre-operative planning based on patient imaging and surgeon preferences, without mentioning any AI or machine learning components.
No.
This device is a pre-operative planning and modeling service for orthopedic surgical procedures, which assists surgeons in planning, but does not directly treat or cure any condition.
No
The device is intended for preoperative planning and modeling services for surgical procedures, not for diagnosing medical conditions. It assists with implant placement and evaluating modifications.
Yes
The device explicitly states it is "Software as a Medical Device (SaMD)" and "comprised of several medical software systems (modules)." The description details software functions like pre-operative plan generation, modification, and impingement analysis tools, with no mention of proprietary hardware provided or required by the manufacturer as part of the medical device. While it processes imaging data and generates plans, these are software functionalities.
No.
This device is a surgical planning software that uses patient imaging to generate pre-operative plans. It does not perform tests on biological samples or provide diagnostic information about a patient's health status.
N/A
Intended Use / Indications for Use
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures:
- Unicondylar Knee Replacement (UKR)
- Total Knee Arthroplasty (TKA)
- Primary Total Hip Arthroplasty (THA)
- Primary Anatomic Total Shoulder Arthroplasty (aTSA)
- Primary Reverse Total Shoulder Arthroplasty (rTSA)
Product codes (comma separated list FDA assigned to the subject device)
PBF
Device Description
CORIOGRAPH Pre-Op Planning and Modeling Services (CORIOGRAPH) are Software as a Medical Device (SaMD) that provide pre-operative planning for orthopedic surgical procedures based on patient imaging, surgeon preferences and implant geometry. CORIOGRAPH is comprised of several medical software systems (modules), and these modules share a set of non-medical function software applications called the Case Processing System.
CORIOGRAPH is a Software Medical Device System. The medical function modules share a graphic user interface where the surgeon provides their case preferences and patient imaging, retrieves PDF plans generated by the Pre-Op Plan modules, and launches the Modeler modules.
CORIOGRAPH Pre-Op Plan Modules: Using patient-specific information, patient imaging, and surgeon inputs, a pre-operative plan is generated by Smith+Nephew personnel. The plan provides initial alignment recommendations to the surgeon on implant placement based on the geometries of the implant and of the generated bone models.
CORIOGRAPH Hip Modeler and CORIOGRAPH Shoulder Modeler Modules: CORIOGRAPH Hip Modeler and CORIOGRAPH Shoulder Modeler are web-based software applications intended for surgeons to modify the patient-specific pre-operative plan and to evaluate the impact of the modifications through the impingement analysis tools such as Impingement-free Range-of Motion (ROM) and Activities of Daily Living (ADL) simulations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Knee Pre-Op Plan: X-Rays, MRI Scan
Hip Pre-Op Plan: X-Ray (option), CT Scan (option)
Shoulder Pre-Op Plan: CT Scan
Anatomical Site
Knee, Hip, Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Testing (Bench)
Design verification and validation testing demonstrated that CORIOGRAPH Pre-Op Planning and Modeling Services (v 3.0) meets all design requirements and is as safe and effective as its primary and secondary predicate devices. Comprehensive testing demonstrated that the system, including the two new medical function modules, CORIOGRAPH Shoulder Pre-Op Plan (v1.0) and CORIOGRAPH Shoulder Modeler (v1.0), meet required design inputs. Additionally, the following evidence was provided:
- Software verification testing, including software integration and workflow testing, was completed. Software was developed in accordance with IEC 62304 Medical device software - Software life cycle processes, and this submission contains documentation per the requirements of FDA's Guidance for the Content of Premarket Submissions for Device Software Functions.
- The credibility evaluation demonstrated that the kinematic models and Activities of Daily Living (ADLs) simulations utilized in the subject device are clinically relevant.
- Summative usability validation testing demonstrated that representative users were able to use the subject device safely and effectively in a simulated use environment. Human factors and usability engineering processes were followed per IEC 62366 - Application of Usability Engineering to Medical Devices.
The results of the Summative Usability/Human Factors Validation study provided objective evidence that the surgeon-facing aspects of CORIOGRAPH Shoulder Pre-Op Plan and CORIOGRAPH Shoulder Modeler have been designed for safe and effective use for the intended users, intended uses, and under the expected use conditions.
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.
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.
Not Found
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
FDA 510(k) Clearance Letter - CORIOGRAPH Pre-Op Planning and Modeling Services
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 25, 2025
Blue Belt Technologies, Inc.
Corrine Herlinger
Senior Principal Regulatory Affairs Specialist
2875 Railroad Street
Pittsburgh, Pennsylvania 15090
Re: K250921
Trade/Device Name: CORIOGRAPH Pre-Op Planning and Modeling Services
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
Regulatory Class: Class II
Product Code: PBF
Dated: May 28, 2025
Received: May 28, 2025
Dear Corrine Herlinger:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
June 25, 2025
Blue Belt Technologies, Inc.
Corrine Herlinger
Senior Principal Regulatory Affairs Specialist
2875 Railroad Street
Pittsburgh, Pennsylvania 15090
Re: K250921
Trade/Device Name: CORIOGRAPH Pre-Op Planning and Modeling Services
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
Regulatory Class: Class II
Product Code: PBF
Dated: May 28, 2025
Received: May 28, 2025
Dear Corrine Herlinger:
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.
Page 2
K250921 - Corrine Herlinger Page 2
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).
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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250921 - Corrine Herlinger Page 3
assistance/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,
Shumaya Ali -S
Shumaya Ali, M.P.H.
Assistant Director
DHT6C: Division of Restorative,
Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250921
Device Name: CORIOGRAPH Pre-Op Planning and Modeling Services
Indications for Use (Describe)
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures:
- Unicondylar Knee Replacement (UKR)
- Total Knee Arthroplasty (TKA)
- Primary Total Hip Arthroplasty (THA)
- Primary Anatomic Total Shoulder Arthroplasty (aTSA)
- Primary Reverse Total Shoulder Arthroplasty (rTSA)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
510(k) Number (if known): K250921
Device Name: CORIOGRAPH Pre-Op Planning and Modeling Services
Indications for Use (Describe)
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures:
- Unicondylar Knee Replacement (UKR)
- Total Knee Arthroplasty (TKA)
- Primary Total Hip Arthroplasty (THA)
- Primary Anatomic Total Shoulder Arthroplasty (aTSA)
- Primary Reverse Total Shoulder Arthroplasty (rTSA)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1
Page 5
Blue Belt Technologies, Inc.
T: 412-683-3844
2875 Railroad Street
www.smith-nephew.com
Pittsburgh, Pennsylvania 15222
USA
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
Page 1 of 6
510(k) Summary
| Field | Details |
|---|---|
| 510(k) Owner | Blue Belt Technologies, Inc. |
| 2875 Railroad Street | |
| Pittsburgh, Pennsylvania 15222 | |
| Contact Person | Corrine Herlinger |
| Senior Principal Regulatory Affairs Specialist | |
| Email: corrine.herlinger@smith-nephew.com | |
| Date Prepared | March 26, 2025 |
| Classification Reference | 21 CFR 888.3030 |
| Product Code | PBF |
| Common/Usual Name | Orthopaedic Surgical Planning and Instrument Guides |
| Trade/Proprietary Name | CORIOGRAPH Pre-Op Planning and Modeling Services |
| Primary Predicate Device | CORIOGRAPH Pre-Op Planning and Modeling Services (K242272) |
| Secondary Predicate Device | Materialise SurgiCase Shoulder Planner (K242813) |
| Reason for Submission | The purpose of this Traditional 510(k) submission is to seek clearance for a proposed modification to the CORIOGRAPH Pre-Op Planning and Modeling Services (CORIOGRAPH) Indications for Use to add Primary Anatomic Total Shoulder Arthroplasty (aTSA) and Primary Reverse Total Shoulder Arthroplasty (rTSA) procedures. |
Page 6
Blue Belt Technologies, Inc.
T: 412-683-3844
2875 Railroad Street
www.smith-nephew.com
Pittsburgh, Pennsylvania 15222
USA
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
Page 2 of 6
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures:
- unicondylar knee replacement (UKR)
- total knee arthroplasty (TKA)
- Primary total hip arthroplasty (THA)
- Primary anatomic Total Shoulder Arthroplasty (aTSA)
- Primary reverse Total Shoulder Arthroplasty (rTSA)
Device Description
CORIOGRAPH Pre-Op Planning and Modeling Services (CORIOGRAPH) are Software as a Medical Device (SaMD) that provide pre-operative planning for orthopedic surgical procedures based on patient imaging, surgeon preferences and implant geometry. CORIOGRAPH is comprised of several medical software systems (modules), and these modules share a set of non-medical function software applications called the Case Processing System.
CORIOGRAPH is a Software Medical Device System. The medical function modules share a graphic user interface where the surgeon provides their case preferences and patient imaging, retrieves PDF plans generated by the Pre-Op Plan modules, and launches the Modeler modules.
CORIOGRAPH Pre-Op Plan Modules
Using patient-specific information, patient imaging, and surgeon inputs, a pre-operative plan is generated by Smith+Nephew personnel. The plan provides initial alignment recommendations to the surgeon on implant placement based on the geometries of the implant and of the generated bone models.
CORIOGRAPH Hip Modeler and CORIOGRAPH Shoulder Modeler Modules
CORIOGRAPH Hip Modeler and CORIOGRAPH Shoulder Modeler are web-based software applications intended for surgeons to modify the patient-specific pre-operative plan and to evaluate the impact of the modifications through the impingement analysis tools such as Impingement-free Range-of Motion (ROM) and Activities of Daily Living (ADL) simulations.
Page 7
Blue Belt Technologies, Inc.
T: 412-683-3844
2875 Railroad Street
www.smith-nephew.com
Pittsburgh, Pennsylvania 15222
USA
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
Currently Supported Implants
CORIOGRAPH is compatible with the following Smith+Nephew implant systems:
| Implant System Name | 510(k) |
|---|---|
| Knee Implants | |
| JOURNEY II Unicompartmental Knee System | K191211 |
| JOURNEY UNI | K102069 |
| JOURNEY II CR | K121443 |
| JOURNEY II BCS | K111711 |
| JOURNEY II XR | K141471, K152726 |
| LEGION CR/PS | K951987, K962557, K093746 |
| LEGION Porous CR Femoral Components | K073325, K091543 |
| LEGION Porous CR Narrow Femoral Components | K210566 |
| LEGION Porous Tibia | K100897 |
| Porous Tibia Baseplate | K211221 |
| GENESIS II CR/PS | K951987, K962557 |
| ANTHEM | K142807 |
| LEGION Knee System | K180334 |
| Hip Implants | |
| ANTHOLOGY HIP SYSTEM | K211176 |
| CATALYSTEM | K240381 |
| CPCS CEMENTED HIP SYSTEM | K970351, K211176 |
| POLARSTEM | K203175, K211176 |
| REDAPT MONOBLOCK REVISION FEMORAL SYSTEM | K211176 |
| SL-PLUS AND SLR-PLUS CEMENTLESS FEMORAL HIP SYSTEM | K211176 |
| SYNERGY HIP SYSTEM | K963509, K211176 |
| FEMORAL HEADS | K021673, K211176 |
| OR3O HIP SYSTEM | K220959, K232667 |
| R3 ACETABULAR SYSTEM - STIKTITE SHELLS | K070756 |
| R3 ACETABULAR SYSTEM | K211176 |
| REDAPT ACETABULAR SYSTEM | K211176 |
| Shoulder | |
| AETOS Implant system | K230572, K220847 |
Page 8
Blue Belt Technologies, Inc.
T: 412-683-3844
2875 Railroad Street
www.smith-nephew.com
Pittsburgh, Pennsylvania 15222
USA
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
Page 4 of 6
Discussion of Similarities and Differences
The purpose of this Traditional 510(k) submission is to seek clearance for a proposed modification to the CORIOGRAPH Pre-Op Planning and Modeling Services (CORIOGRAPH) Indications for Use to add Primary Anatomic Total Shoulder Arthroplasty (aTSA) and Primary Reverse Total Shoulder Arthroplasty (rTSA) procedures. The proposed modifications introduce two new medical function modules in CORIOGRAPH v3.0: CORIOGRAPH Shoulder Pre-Op Plan (v1.0) and CORIOGRAPH Shoulder Modeler (v1.0).
CORIOGRAPH Pre-Op Planning & Modeling Services v3.0 has a similar intended use, indications for use, and technological characteristics as the primary predicate device, CORIOGRAPH Pre-Op Planning and Modeling Services (K242272) v2.0, and secondary predicate device, Materialise SurgiCase Shoulder Planner (K242813). CORIOGRAPH Shoulder Pre-Op Plan shares the same software and planning processes as used in the primary predicate device. The CORIOGRAPH Shoulder Modeler Application allows the surgeon to evaluate the plan with impingement-free ROM and ADL simulations, which is substantially equivalent to CORIOGRAPH Hip Modeler (K242272).
Table 1: Substantial Equivalence Table
| CORIOGRAPH Pre-Operative Planning Services v3.0 Subject Device | CORIOGRAPH Pre-Operative Planning and Modeling Services v2.0 (K242272) Primary Predicate | Materialise Shoulder System / SurgiCase Shoulder Planner (K242813) Secondary Predicate | |
|---|---|---|---|
| Indications for Use | Intended Use | ||
| CORIOGRAPH Pre-operative Planning Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans. |
Indications for Use
The CORIOGRAPH Pre-operative Planning Services are indicated for use for the following procedures:
• Unicondylar Knee Replacement (UKR)
• Total Knee Arthroplasty (TKA)
• Primary Total Hip Arthroplasty (THA)
• Primary Anatomic Total Shoulder Arthroplasty (aTSA)
• Primary Reverse Total Shoulder Arthroplasty (rTSA) | Intended Use
CORIOGRAPH Pre-operative Planning Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-operative Planning Services are indicated for use for the following procedures:
• Unicondylar Knee Replacement (UKR)
• Total Knee Arthroplasty (TKA)
• Primary Total Hip Arthroplasty (THA) | SurgiCase Shoulder Planner Indication for Use
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 Code | PBF | PBF | QHE |
| Target Anatomy | Knee
Hip
Shoulder | Knee
Hip | Shoulder |
Page 9
Blue Belt Technologies, Inc.
T: 412-683-3844
2875 Railroad Street
www.smith-nephew.com
Pittsburgh, Pennsylvania 15222
USA
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
Page 5 of 6
| CORIOGRAPH Pre-Operative Planning Services v3.0 Subject Device | CORIOGRAPH Pre-Operative Planning and Modeling Services v2.0 (K242272) Primary Predicate | Materialise Shoulder System / SurgiCase Shoulder Planner (K242813) Secondary Predicate | |
|---|---|---|---|
| Target Population | CORIOGRAPH Pre-Op Planning and Modeling Services may be used for patients who are able to undergo an MRI, CT, or X-ray safely, fit the indications, and do not present any of the contraindications for the existing Smith+Nephew implant systems to which the plan is designed. | CORIOGRAPH Pre-Op Planning and Modeling Services may be used for patients who are able to undergo an MRI, CT, or X-ray safely, fit the indications, and do not present any of the contraindications for the existing Smith+Nephew implant systems to which the plan is designed. | Adults |
| Compatible Shoulder Implant Systems | AETOS Total Shoulder System | ||
| AETOS Reverse Shoulder System | N/A | AETOS Total Shoulder System | |
| AETOS Reverse Shoulder System | |||
| (This is a subset of the implants the Materialise System is compatible with - See K242813 for a complete list) | |||
| Pre-Op Plan Input | Knee Pre-Op Plan: | ||
| • Surgeon Preferences | |||
| • X-Rays | |||
| • MRI Scan |
Hip Pre-Op Plan:
• Surgeon Preferences
• X-Ray (option)
• CT Scan (option)
Shoulder Pre-Op Plan:
• Surgeon Preferences
• CT Scan | Knee Pre-Op Plan:
• Surgeon Preferences
• X-Rays
• MRI Scan
Hip Pre-Op Plan:
• Surgeon Preferences
• X-Ray (option)
• CT Scan (option) | CT Scan |
| Pre-Op Plan Output | Knee
Pre-operative surgical plan provided in PDF for surgeon review. After surgeon acceptance of the plan parameters, PDF and/or software file is provided to be used as an input to CORI Surgical System.
Hip/Shoulder
Pre-operative surgical plan provided in PDF for surgeon review. After surgeon acceptance of the plan parameters, PDF and/or software file is provided to be used as an input to modeler module.
Hip or Shoulder Modeler module may output a Surgeon Modified Pre-Op Plan based on initial plan generated by the Hip or Shoulder Pre-Op Plan Module. | Knee
Pre-operative surgical plan provided in PDF for surgeon review. After surgeon acceptance of the plan parameters, PDF and/or software file is provided to be used as an input to CORI Surgical System.
Hip
Pre-operative surgical plan provided in PDF for surgeon review. After surgeon acceptance of the plan parameters, PDF and/or software file is provided to be used as an input to modeler module.
Hip Modeler module may output a Surgeon Modified Pre-Op Plan based on initial plan generated by Hip Pre-Op Plan Module. | The SurgiCase Shoulder Planner allows for the creation of a glenoid and/or humeral pre-operative plan. The software leads to the generation of a surgery report along with a presurgical plan data file. |
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Blue Belt Technologies, Inc.
T: 412-683-3844
2875 Railroad Street
www.smith-nephew.com
Pittsburgh, Pennsylvania 15222
USA
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
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Non-Clinical Testing (Bench)
Design verification and validation testing demonstrated that CORIOGRAPH Pre-Op Planning and Modeling Services (v 3.0) meets all design requirements and is as safe and effective as its primary and secondary predicate devices. Comprehensive testing demonstrated that the system, including the two new medical function modules, CORIOGRAPH Shoulder Pre-Op Plan (v1.0) and CORIOGRAPH Shoulder Modeler (v1.0), meet required design inputs. Additionally, the following evidence was provided:
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Software verification testing, including software integration and workflow testing, was completed. Software was developed in accordance with IEC 62304 Medical device software - Software life cycle processes, and this submission contains documentation per the requirements of FDA's Guidance for the Content of Premarket Submissions for Device Software Functions.
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The credibility evaluation demonstrated that the kinematic models and Activities of Daily Living (ADLs) simulations utilized in the subject device are clinically relevant.
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Summative usability validation testing demonstrated that representative users were able to use the subject device safely and effectively in a simulated use environment. Human factors and usability engineering processes were followed per IEC 62366 - Application of Usability Engineering to Medical Devices.
The results of the Summative Usability/Human Factors Validation study provided objective evidence that the surgeon-facing aspects of CORIOGRAPH Shoulder Pre-Op Plan and CORIOGRAPH Shoulder Modeler have been designed for safe and effective use for the intended users, intended uses, and under the expected use conditions.
Conclusion
Verification testing demonstrated that the system meets required design inputs. Summative usability testing demonstrated that representative users could use the subject device safely and effectively under the expected use conditions. Blue Belt Technologies, Inc. has concluded that all design inputs have been met and that the verification and validation testing performed did not raise any new questions of safety or effectiveness.
The information presented in this 510(k) premarket notification demonstrates that the CORIOGRAPH Pre-Op Planning & Modeling Services v3.0, specifically the CORIOGRAPH Shoulder Pre-Op Plan (v1.0) and CORIOGRAPH Shoulder Modeler (v1.0), may be used to generate pre-operative plans for surgical procedures based on patient imaging. Blue Belt Technologies, Inc. believes that FDA can find CORIOGRAPH Pre-Op Planning & Modeling Services V3.0 to be substantially equivalent to the primary and secondary predicate devices.