Blue Belt Technologies, Inc.
Pittsburgh, PA, US
Blue Belt Technologies, Inc. appears in FDA device records in Pittsburgh, PA. FDA records list 22 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 22 510(k) clearances for Blue Belt Technologies, Inc. between 2012 and 2026. The busiest year on record is 2022, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260601 | REAL INTELLIGENCE™ CORI™ | OLO | Substantially Equivalent | |
| K252841 | REAL INTELLIGENCE™ CORI™ XT (CORI XT) | OLO | Substantially Equivalent | |
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | PBF | Substantially Equivalent | |
| K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Substantially Equivalent | ||
| K240139 | Real Intelligence™ CORI™ | OLO | Substantially Equivalent | |
| K231963 | REAL INTELLIGENCE™ CORI™ | OLO | Substantially Equivalent | |
| K221224 | REAL INTELLIGENCE CORI | OLO | Substantially Equivalent | |
| K220958 | Real Intelligence Cori | OLO | Substantially Equivalent | |
| K220255 | REAL INTELLIGENCE CORI | OLO | Substantially Equivalent | |
| K212040 | RI.HIP MODELER | LLZ | Substantially Equivalent | |
| K212537 | REAL INTELLIGENCE CORI (CORI) | OLO | Substantially Equivalent | |
| K201022 | REAL INTELLIGENCE CORI (CORI) | OLO | Substantially Equivalent | |
| K193120 | Real Intelligence Cori | OLO | Substantially Equivalent | |
| K191223 | NAVIO | OLO | Substantially Equivalent | |
| K180271 | NAVIO™ Surgical System (NAVIO system) | OLO | Substantially Equivalent | |
| K170360 | NAVIO | OLO | Substantially Equivalent | |
| K160537 | Navio | OLO | Substantially Equivalent | |
| K152574 | Navio | OLO | Substantially Equivalent | |
| K143668 | Navio | OLO | Substantially Equivalent | |
| K140596 | NAVIO | OLO | Substantially Equivalent | |
| K123380 | STRIDE UNICONDYLAR KNEE | HSX | Substantially Equivalent | |
| K121936 | NAVIOPFS | OLO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016090213 | 3016090213 | Blue Belt Technologies, Inc. | 2875 Railroad Street, Pittsburgh, PA 15222 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PBFOrthopaedic Surgical Planning And Instrument Guides
- OLOOrthopedic Stereotaxic Instrument
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- LLZSystem, Image Processing, Radiological
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2135-2024 | CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence CORI (3) ROB10197 CORI STARTER KIT - UNIVERSAL Note: the three product numbers cover the three different configurations in which the CORI Console is sold | CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay | Class II | Open, Classified | |
| Z-0708-2024 | CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S | Possibility that the user is unable to resolve drill disconnection error messages. | Class II | Open, Classified | |
| Z-0041-2024 | Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299 | CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational reference via the posterior condylar axis | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain