# CORIOGRAPH Pre-Op Planning and Modeling Services (K242272) _Blue Belt Technologies, Inc. · Nov 15, 2024 · OR · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K242272 ## Device Facts - **Applicant:** Blue Belt Technologies, Inc. - **Decision Date:** Nov 15, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Review Panel:** OR - **Attributes:** Software as a Medical Device ## 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. ## Device Story CORIOGRAPH Pre-Op Planning and Modeling Services provide preoperative surgical planning for orthopedic procedures. Input data includes patient imaging (CT, MRI, X-ray) and surgeon preferences. Smith & Nephew personnel generate patient-specific bone models and preoperative plans, which are then viewable and editable by surgeons via the CORIOGRAPH Modeler software. The device is used in professional healthcare facilities. The output—a preoperative surgical plan and implant position simulation—assists surgeons in clinical decision-making regarding component selection and positioning. Benefits include patient-matched planning to support surgical accuracy. ## Clinical Evidence Bench testing only. Verification and validation testing confirmed software safety and effectiveness. Summative usability testing in a simulated environment demonstrated that surgeons could use the device safely and effectively. Credibility evaluation confirmed the clinical relevance of kinematic models and Activities of Daily Living (ADLs) used in the device. ## Technological Characteristics Software as a Medical Device (SaMD) for orthopedic surgical planning. Utilizes patient imaging (CT, MRI, X-ray) to generate 3D bone models and implant simulations. Compatible with specific Smith & Nephew hip and knee implant systems. Operates in professional healthcare facilities. Connectivity involves viewing/editing via the CORIOGRAPH Modeler software. ## Predicate Devices - CORIOGRAPH Knee Pre-Op Plan ([K240113](/device/K240113.md)) - RI.HIP Modeler ([K212040](/device/K212040.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text. November 15, 2024 Blue Belt Technologies, Inc. Chandler Caufield Senior Regulatory Affairs Specialist 2875 Railroad Street Pittsburgh, Pennsylvania 15222 Re: K242272 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: July 31, 2024 Received: August 1, 2024 ### Dear Chandler Caufield: 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. 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 Rue"). 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-device-advicecomprehensive-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-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). {2}------------------------------------------------ Sincerely, # Tejen D. Soni -S For 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K242272 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) | 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) #### 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." {4}------------------------------------------------ 2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA Image /page/4/Picture/3 description: The image shows the logo for Smith+Nephew. The logo is in a bright orange color. The words "Smith" and "Nephew" are connected by a plus sign. #### Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc. ## 510(k) Summary | 510(k) Owner | Blue Belt Technologies, Inc.
2875 Railroad Street
Pittsburgh, Pennsylvania 15222 | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Chandler Caufield
Senior Regulatory Affairs Specialist
Email: chandler.caufield@smith-nephew.com | | Date Prepared | 31-July-2024 | | Classification Reference | 21 CFR 888.3030 | | Product Code | PBF | | Supported Codes | JDI, KWZ, LPH, LWJ, LZO, MBL, MEH | | Common/Usual Name | Orthopaedic Surgical Planning and Instrument Guides | | Trade/Proprietary Name | CORIOGRAPH Pre-Op Planning and Modeling Services | | Primary Predicate Device | CORIOGRAPH Knee Pre-Op Plan (K240113) | | Secondary Predicate
Device | RI.HIP Modeler (K212040) | | Reason for Submission | This Traditional 510(k) submission is seeking clearance for a new
offering CORIOGRAPH Hip Pre-Op Plan V1.0 and CORIOGRAPH Modeler
V1.0, modules of the CORIOGRAPH Pre-Op Planning and Modeling
Services V2.0. | {5}------------------------------------------------ 2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA T: 412-683-3844 Smith+Nephew www.smith-nephew.com Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc. ## 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 generating the plan are identifiable on patient imaging scans. ## Indications for Use The CORIOGRAPH Pre-op Planning and Modeling Service is indicated for use for the following procedures: - unicondylar knee replacement (UKR) - . total knee arthroplasty (TKA) - . primary total hip arthroplasty (THA) ## Device Description The subject CORIOGRAPH Hip Pre-Op Plan and CORIOGRAPH Modeler are medical function modules within the CORIOGRAPH Pre-Op Planning and Modeling Services are additional offerings being introduced by Blue Belt Technologies, Inc. to allow for pre-operative planning for surgical procedures based on patient imaging for primary total hip arthroplasty (THA). The CORIOGRAPH Hip Pre-Op Plan system will utilize Smith and Nephew personnel to generate patient specific bone models and preoperative plans for primary THA which will be viewable and editable on CORIOGRAPH Modeler 1.0. Together, CORIOGRAPH Hip Pre-Op Plan and CORIOGRAPH Modeler are the subject of this submission. {6}------------------------------------------------ T: 412-683-3844 www.smith-nephew.com Image /page/6/Picture/2 description: The image shows the logo for Smith+Nephew. The logo is in orange and features the company name in a sans-serif font. The plus sign is slightly larger than the other characters and is positioned between "Smith" and "Nephew." 2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc. ## Currently Supported Hip Implants The CORIOGRAPH Hip Pre-Op Plan is compatible with implant systems provided in Table 1. TABLE 1. CURRENTLY SUPPORTED SMITH+ NEPHEW HIP IMPLANTS FOR THE CORIOGRAPH HIP PRE-OP PLAN V1.0 | Implant System Name | 510(k) | |----------------------------------------------------|---------| | 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 | | OR30 HIP SYSTEM | K220959 | | | K232667 | | R3 ACETABULAR SYSTEM - STIKTITE SHELLS | K070756 | | R3 ACETABULAR SYSTEM | K211176 | | REDAPT ACETABULAR SYSTEM | K211176 | ## Discussion of Similarities and Differences The purpose of this Traditional 510(k) submission is to seek clearance for the CORIOGRAPH Hip Pre-Op Plan V1.0 and CORIOGRAPH Modeler V1.0, which are medical function modules of the CORIOGRAPH Pre-Op Planning and Modeling Services V2.0. This Software as a Medical Device (SaMD) is based on CORIOGRAPH Knee Pre-Op Plan V1.0 also used to generate preoperative plans (K240113) as well as the secondary predicate RI.HIP Modeler (K212040). The software planning tools and processes used for the CORIOGRAPH Hip Pre-Op Plan have similar intended use, indications for use and technological characteristics as the software planning tools used for the preoperative plans generated for surgeon concurrence in the predicate CORIOGRAPH Knee Pre-Op Plan V1.0 (K240113) as well as in the secondary predicate RI.HIP Modeler (K212040). Smith & Nephew believes that CORIOGRAPH Hip Pre-Op Plan V1.0 is subject to premarket notification requirements under Section 510(k) of the Federal Food, Drug and Cosmetic Act ("FFDCA" or "the Act") and is substantially equivalent to the previously cleared primary predicate CORIOGRAPH Knee Pre-Op Plan V1.0 (K240113) and secondary predicate RI.HIP Modeler (K212040). {7}------------------------------------------------ T: 412-683-3844 www.smith-nephew.com Image /page/7/Picture/2 description: The image shows the logo for Smith+Nephew. The logo is in orange color. The words "Smith" and "Nephew" are connected by a plus sign. 2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc. #### Table 2. Primary Predicate Device | Manufacturer | Description | Submission Number | Clearance Date | |----------------------|--------------------------------------|-------------------|----------------| | Smith & Nephew, Inc. | CORIOGRAPH Knee Pre-
Op Plan V1.0 | K240113 | 03/18/2024 | #### Table 3. Secondary Predicate Device | Manufacturer | Description | Submission Number | Clearance Date | |-----------------------------|----------------|-------------------|----------------| | Blue Belt Technologies Inc. | RI.HIP MODELER | K212040 | 03/11/2022 | Substantial equivalence analysis for the CORIOGRAPH Knee Pre-Op Plan is provided in Table 4. {8}------------------------------------------------ 2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA #### T: 412-683-3844 www.smith-nephew.com #### Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc. #### Table 4. Substantial Equivalence Table | Design Aspect
Reviewed | CORIOGRAPH Hip Pre-Op Plan
(Subject Device) | CORIOGRAPH Knee Pre-Op Plan
(Primary Predicate Device) | RI.HIP Modeler
(Secondary Predicate Device) | Comparison | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K242272 | K240113 | K212040 | N/A | | Indications for
Use | Intended Use
CORIOGRAPH Pre-operative Planning
Service is intended to
provide pre-operative
planning for surgical
procedures based on
patient imaging,
provided that anatomic
landmarks necessary
generating the plan are
identifiable on patient
imaging scans.

Indications for Use
The CORIOGRAPH Pre-operative Planning
Service is indicated for
use for the following
procedures:
unicondylar knee
replacement (UKR) total knee
arthroplasty (TKA) primary total hip
arthroplasty (THA) | Intended Use
CORIOGRAPH Pre-operative Planning
Service is intended to
provide pre-operative
planning for surgical
procedures based on
patient imaging,
provided that
anatomic landmarks
necessary for
alignment and
positioning of the
implant are
identifiable on patient
imaging scans.

Indications for Use
The CORIOGRAPH Pre-operative Planning
Service is indicated for
use for the following
procedures:
unicondylar knee
replacement
(UKR) total knee
arthroplasty (TKA) | Intended Use
The RI.HIP MODELER is
intended for
preoperative planning
for primary total hip
arthroplasty. RI.HIP
MODELER is intended
to be used as a tool to
assist the surgeon in
the selection and
positioning of
components in primary
total hip arthroplasty.

Indications for Use
RI.HIP MODELER is
indicated for
individuals undergoing
primary hip surgery. | Substantially
equivalent -
New indication
added for Total Hip
Arthroplasty Introduction of Hip
Modules has made
the services offered
plural. Anatomic
landmarks
necessary
statement has
changed from
"alignment and
positioning of
implant" to
"generating the
plan". | {9}------------------------------------------------ 2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA www.smith-nephew.com #### Smith ew | | | Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc. | | | | | | | | |--|--|----------------------------------------------------------------------|--|--|--|--|--|--|--| |--|--|----------------------------------------------------------------------|--|--|--|--|--|--|--| | Design Aspect
Reviewed | CORIOGRAPH Hip Pre-
Op Plan
(Subject Device) | CORIOGRAPH Knee
Pre-Op Plan
(Primary Predicate
Device) | RI.HIP Modeler
(Secondary Predicate
Device) | Comparison | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Target
Population | Patients who are able
to undergo an CT
safely, fit the
indications, and do not
present any
contraindications for
the existing hip implant
system to which it is
designed. | Patients who are able
to undergo an MRI
safely, fit the
indications, and do
not present any
contraindications for
the existing knee
implant system to
which it is designed. | The patient population
is adults only. | Substantially
equivalent -
CORIOGRAPH Pre-Op
Planning and Modeling
Services is
incorporating new
modules that use an
alternative imaging
modality with potential
patient restrictions.
Therefore, the Target
Population statement is
being updated to
reflect the broader
applications. | | Target
Anatomy | Knee
Hip | Knee | Hip | Substantially
equivalent -
CORIOGRAPH Pre-Op
Planning and Modeling
Services are expanding
the offering to planning
for Hip implants.
Compatible implants
for both primary
predicate device and
secondary predicate
device are implants
manufactured by Blue
Belt Technologies,
Inc.'s parent company
Smith+Nephew. | | Where used | Professional healthcare
facility | Professional
healthcare facility | Clinical Setting | Same as primary
predicate | | Compatible
Total Knee
Systems | Smith and Nephew Inc.
Implants:
Genesis II CR
Genesis II PS
LEGION CR
LEGION PS
Journey II BCS
Journey II CR
Journey II XR
JOURNEY II
Unicompartmental Knee | Smith and Nephew Inc.
Implants:
Genesis II CR
Genesis II PS
LEGION CR
LEGION PS
Journey II BCS
Journey II CR
Journey II XR
JOURNEY II
Unicompartmental Knee | N/A | Same as primary
predicate | | Design Aspect
Reviewed | CORIOGRAPH Hip Pre-
Op Plan
(Subject Device) | CORIOGRAPH Knee
Pre-Op Plan
(Primary Predicate
Device) | RI.HIP Modeler
(Secondary Predicate
Device) | Comparison | | Compatible
Total Hip
Systems | Smith and Nephew Inc.
Implants:
ANTHOLOGY HIP System
CATALYSTEM
CPCS Cemented Hip
System
POLARSTEM Standard
Offset Stem
POLARSTEM Lateral Offset
Stem
POLARSTEM Valgus Offset
Stem REDAPT Monoblock
Revision Femoral System
SL-PLUS AND SLR-PLUS
Cementless Femoral Hip
System
Femoral Heads
OR30 Hip System
R3 Acetabular System
R3 Acetabular System
Anteverted Liner
R3 Constrained Liner
SYNERGY Hip System | N/A | Smith and Nephew Inc.
Implants:
ANTHOLOGY Stem
POLARSTEM Standard
Offset Stem
POLARSTEM Lateral Offset
Stem
POLARSTEM Valgus Offset
Stem
Femoral Heads
R3 Acetabular System
R3 Acetabular System
Anteverted Liner
R3 Constrained Liner
OR30 Liner
SYNERGY Hip system | Substantially
equivalent to
secondary predicate.
CORIOGRAPH Pre-Op
Planning and Modeling
Services are expanding
the CORIOGRAPH
offering to planning for
primary Total Hip
Arthroplasty Hip
implants. Compatible
implants for both
primary predicate
device and secondary
predicate device are
implants manufactured
by Blue Belt
Technologies, Inc.'s
parent company
Smith+Nephew. | | Design Type | Patient Matched | Patient Matched | Patient Matched | Same as predicate
devices. | | Input | Surgeon Preferences
X-Ray
MRI
CT Scan | Surgeon Preferences
X-Ray
MRI | Surgeon Preferences
X-Ray | Substantially
Equivalent | | Output | Preoperative surgical
plan
Simulation of implant
position | Preoperative surgical
plan | Simulation of implant
position | Substantially
Equivalent - Hip
modules are generating
a preoperative plan
that the surgeon may
use to drive clinical
decisions which is
similar to the Knee
module.
Computational
modeling simulation is
equivalent to
Secondary Predicate
Device RI.HIP
MODELER. | | Design Aspect
Reviewed | CORIOGRAPH Hip Pre-
Op Plan
(Subject Device) | CORIOGRAPH Knee
Pre-Op Plan
(Primary Predicate
Device) | RI.HIP Modeler
(Secondary Predicate
Device) | Comparison | | Common Name | Orthopaedic Surgical
Planning and
Instrument Guides | Orthopaedic Surgical
Planning and
Instrument Guides | System, Image
Processing, Radiological | Same as primary
predicate | | Device Class | Class II | Class II | Class II | Same as primary
predicate and
secondary predicate | | Device
Classification
Name and
Reference | 21 CFR 888.3030 -
Single/multiple
component metallic
bone fixation
appliances and
accessories. | 21 CFR 888.3030 -
Single/multiple
component metallic
bone fixation
appliances and
accessories. | 21 CFR 892.2050 -
Medical image
management and
processing system. | Same as primary
predicate | | Panel Code | Orthopaedics/87 | Orthopaedics/87 | Radiology/90 | Same as primary
predicate | | Product Code | PBF | PBF | LLZ | Same as primary
predicate | | Supported
Product Code
(Knee) | HSX | HSX | N/A | Same as primary
predicate | | | JWH | JWH | N/A | | | | MBH | MBH | N/A | | | | OOG | OOG | N/A | | | Supported
Product Code
(Hip) | JDI | N/A | JDI | Same as secondary
predicate | | | KWZ | N/A | KWZ | | | | LPH | N/A | LPH | | | | LWJ | N/A | LWJ | | | | LZO | N/A | LZO | | | | MBL | N/A | MBL | | | | MEH | N/A | MEH | | {10}------------------------------------------------ 2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA ### T: 412-683-3844 www.smith-nephew.com #### Sn W Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc. {11}------------------------------------------------ T: 412-683-3844 www.smith-nephew.com 2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc. ## Non-Clinical Testing (Bench) Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Pre-Op Planning & Modeling Services V2.0. Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment. In addition, the credibility evaluation demonstrated that the kinematic models and Activities of Daily Living (ADLS) utilized in the subject device are clinically relevant. 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. {12}------------------------------------------------ 2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc. ## Conclusion The software tools and process used for CORIOGRAPH Pre-Op Planning & Modeling Services V2.0 have similar intended use, indications for use and technological characteristics used in the software planning tools and processes used for the preoperative plans generated for the primary predicate CORIOGRAPH Knee Pre-Op Plan (K240113) and the secondary predicate RI.HIP Modeler (K212040). Verification testing demonstrated that the system meets required design inputs. Summative usability testing results demonstrate that representative users can use the safely and effectively in a simulated use environment. The information presented in this 510(k) premarket notification demonstrates that the CORIOGRAPH Pre-Op Planning & Modeling Services V2.0, specifically the CORIOGRAPH Hip Pre-Op Plan System V1.0 and the CORIOGRAPH Modeler V1.0 may be used to generative plans for surgical procedures based on patient imaging. This information also demonstrates that the CORIOGRAPH Pre-Op Planning & Modeling Services V2.0 are as safe and effective as the software and planning process used in the primary predicate CORIOGRAPH Knee Pre-Op Plan (K240113) and secondary predicate RI.HIP Modeler (K212040). Blue Belt Technologies, Inc. believes that FDA can find CORIOGRAPH Pre-Op Planning & Modeling Services V2.0 to be substantially equivalent to the primary and secondary predicate devices. --- **Source:** [https://fda.innolitics.com/device/K242272](https://fda.innolitics.com/device/K242272) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com