(30 days)
REAL INTELLIGENCE CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include:
- unicondylar knee replacement (UKR),
- total knee arthroplasty (TKA),
- revision knee arthroplasty, and
- total hip arthroplasty (THA).
The subject of this Special 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur.
CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:
- Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
- Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached.
Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.
N/A
FDA 510(k) Clearance Letter - REAL INTELLIGENCE™ CORI™
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.04
March 26, 2026
Blue Belt Technologies, Inc.
Samantha Zanetti
Senior Regulatory Affairs Specialist
2875 Railroad St.
Pittsburgh, Pennsylvania 15222
Re: K260601
Trade/Device Name: Real Intelligence™ Cori™
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO, HSX, JWH, MBH, NJD,
Dated: February 23, 2026
Received: February 24, 2026
Dear Samantha Zanetti:
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"
Page 2
(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
Page 3
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
PSC Publishing Services (301) 443-6740 EF
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): K260601
Device Name: REAL INTELLIGENCE™ CORI™ (CORI)
Indications for Use (Describe)
REAL INTELLIGENCE CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include:
- unicondylar knee replacement (UKR),
- total knee arthroplasty (TKA),
- revision knee arthroplasty, and
- total hip arthroplasty (THA).
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
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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."
Page 5
Blue Belt Technologies, Inc.
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.
Page 1 of 6
510(k) Summary
| 510(k) Owner | Blue Belt Technologies, Inc.2875 Railroad StreetPittsburgh, PA 15222 USATel: (412) 683-3844 |
|---|---|
| Contact Person | Samantha ZanettiSenior Regulatory Affairs SpecialistTel: 856.408.4750Email: Samantha.zanetti@smith-nephew.com |
| Date of Submission | February 23, 2026 |
| Classification Reference | 21 CFR 882.4560 |
| Classification Name | Stereotaxic instrument |
| Product Code | OLO |
| Common/Usual Name | Orthopedic Stereotaxic Instrument |
| Trade/Proprietary Name | REAL INTELLIGENCE™ CORI™ (CORI) |
| Predicate Device(s) | REAL INTELLIGENCE™ CORI™ (K240139) |
| Reference Device(s) | REAL INTELLIGENCE™ CORI™ (K191223 and K221224) |
| Reason for Submission | The purpose of this Special 510(k) submission is to seek clearance for modifications to CORI to add feature enhancements to the Total Knee Arthroplasty and Unicondylar Knee Replacement software applications. |
Page 6
Blue Belt Technologies, Inc.
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.
Page 2 of 6
Intended Use
REAL INTELLIGENCE CORI (CORI) is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Indications for Use
REAL INTELLIGENCE CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include:
- unicondylar knee replacement (UKR),
- total knee arthroplasty (TKA),
- revision knee arthroplasty, and
- total hip arthroplasty (THA).
Device Description
The subject of this Special 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur.
CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:
- Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
- Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached.
Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.
Page 7
Blue Belt Technologies, Inc.
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.
Page 3 of 6
Currently Supported Knee Implants
The following Smith+Nephew knee implants are supported on CORI:
Table 1: Currently Supported Smith+ Nephew Knee Implants
| Implant Model Name | 510(k) Number | Classification Product Code |
|---|---|---|
| STRIDE Unicondylar Knee | K123380 | HSX |
| ZUK Select Knee System | K160738 | HSX |
| JOURNEY II Unicompartmental Knee System | K191211 | HSX |
| JOURNEY UNI | K102069 | HSX |
| JOURNEY II CR | K121443 | JWH |
| JOURNEY II BCS | K111711 | JWH |
| JOURNEY II XR | K141471, K152726 | JWH |
| LEGION CR/PS | K951987, K962557, K093746 | JWH |
| LEGION Porous CR Femoral Components | K073325, K091543 | MBH |
| LEGION Porous CR Narrow Femoral Components | K210566 | MBH |
| LEGION Porous Tibia | K100897 | MBH |
| Porous Tibia Baseplate | K211221 | MBH |
| GENESIS II CR/PS | K951987, K962557 | JWH |
| ANTHEM | K142807 | JWH |
| SMITH & NEPHEW, INC. REVISION KNEE SYSTEM | K043440 | JWH |
| REVISION KNEE SYSTEM | K041106 | JWH |
| LEGION RK TIBIAL WEDGES (Hemi-Step & Full-Step) | K953274 | JWH |
| LEGION COBALT CHROME REVISION KNEE SYSTEM | K060742 | JWH |
| LEGION Knee System | K180334 | JWH, MBH |
| ENGAGE Partial Knee System | K190439 | NJD, HSX |
| JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System | K222653 | NJD, HSX |
Page 8
Blue Belt Technologies, Inc.
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.
Page 4 of 6
Discussion of Similarities and Differences
This Special 510(k) submission supports an update for two modifications to the CORI software:
- Addition of a pre-operative planning screen that allows users to modify a pre-operative plan, prior to entering CORI's intraoperative workflow.
- Addition of a new widget to adjust cut planes during revision knee arthroplasty procedures utilizing the TKA application.
The modifications made to support the change do not impact the system's intended use, indications for use, or fundamental scientific technology.
Blue Belt Technologies believes that CORI 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 REAL INTELLIGENCE CORI (K240139).
Table 1: Predicate Device
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | K240139 | March 18, 2024 |
Table 2: Summary of Technological Similarities with Predicate
| Devices | Subject Device CORI | Primary Predicate CORI – K240139 |
|---|---|---|
| Intended use | Same as predicate. | REAL INTELLIGENCE CORI (CORI) is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. |
| Indications for Use | Same as predicate. | REAL INTELLIGENCE CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include:• unicondylar knee replacement (UKR),• total knee arthroplasty (TKA),• revision knee arthroplasty, and• total hip arthroplasty (THA). |
| Environment of Use | Same as predicate. | CORI is intended to be used by trained medical professionals in a hospital or clinical setting equivalent to an orthopedic surgery suite. |
Page 9
Blue Belt Technologies, Inc.
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.
Page 5 of 6
| Devices | Subject Device CORI | Primary Predicate CORI – K240139 |
|---|---|---|
| Technological Characteristics | Same as predicate. | CORI aids the surgeon in planning the surgical implant location and in executing the surgical plan by controlling the cutting engagement of the surgical bur. CORI intraoperative software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:• Exposure control adjusts the bur's exposure with respect to a guard.• Speed control regulates the signal going to the motor control module.When the surgeon encroaches on a portion of bone that is not to be cut, the robotic system will disable cutting by retracting the bur inside the guard or by limiting the speed of the drill. |
The following reference devices were used to demonstrate well-established test methods:
Table 3. Reference Devices
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | K191223 | June 28, 2019 |
| Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | K221224 | August 19, 2022 |
Page 10
Blue Belt Technologies, Inc.
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.
Page 6 of 6
Non-Clinical Testing (Bench)
Design verification and validation testing demonstrated that CORI meets all design requirements and is as safe and effective as its predicate device (K240139). Comprehensive testing demonstrated that the system meets required design inputs. Summative usability testing (including labeling validation) demonstrated that participating surgeons were able to use the subject device safely and effectively in a simulated use environment.
Blue Belt Technologies 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.
Conclusions
The subject device, CORI, described in this submission has the same intended use, indications for use, and the same technological characteristics as the predicate device, CORI (K240139). The difference between the two systems is an update to CORI to add two modifications to the software; a pre-operative planning screen that allows users to modify a pre-operative plan during case-setup and prior to the intraoperative planning states, and a new widget to adjust cut planes during revision knee arthroplasty procedures.
The key determining factor in establishing substantial equivalence is whether the features added to CORI affect the safety and effectiveness of the TKA and UKR planning workflows. Comprehensive verification testing demonstrated that the system meets required design inputs. Summative usability testing results demonstrate that representative users can use the subject device safely and effectively in a simulated use environment.
The information presented in this 510(k) premarket notification demonstrates that CORI with the ability to adjust the pre-operative plan and cut planes (within the TKA application) is as safe and effective as the predicate device (K240139). Blue Belt Technologies believes that FDA can find CORI to be substantially equivalent to the predicate device.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).