510(k) K250921

CORIOGRAPH Pre-Op Planning and Modeling Services by Blue Belt Technologies, Inc. — Product Code PBF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 25, 2025
Date Received: March 27, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Orthopaedic Surgical Planning And Instrument Guides
Device Class: Class II
Regulation Number: 888.3030
Review Panel: OR
Submission Type

As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.

Other clearances by Blue Belt Technologies, Inc.

K252841 — REAL INTELLIGENCE CORI XT (CORI XT) (December 5, 2025)
K242272 — CORIOGRAPH Pre-Op Planning and Modeling Services (November 15, 2024)
K240139 — Real Intelligence CORI (March 18, 2024)
K231963 — REAL INTELLIGENCE CORI (August 1, 2023)
K221224 — REAL INTELLIGENCE CORI (August 19, 2022)
K220958 — Real Intelligence Cori (July 27, 2022)
K220255 — REAL INTELLIGENCE CORI (March 29, 2022)
K212040 — RI.HIP MODELER (March 11, 2022)
K212537 — REAL INTELLIGENCE CORI (CORI) (November 3, 2021)
K201022 — REAL INTELLIGENCE CORI (CORI) (June 12, 2020)

Other clearances for product code PBF

K250711 — VSP Orthopedics System (December 5, 2025)
K242603 — MyPAO SA guides (November 19, 2025)
K251709 — MedCAD® AccuStride System (November 4, 2025)
K250394 — Fine TTO (October 21, 2025)
K250767 — Newclip Patient-matched instrumentation non sterile PSI (October 1, 2025)
K241811 — MedCAD® AccuStride System (March 13, 2025)
K243912 — Newclip Patient-matched instrumentation non sterile PSI (February 13, 2025)
K240415 — Newclip Patient-matched instrumentation non sterile PSI (November 7, 2024)
K240113 — CORIOGRAPH Knee Pre-Op Plan (March 18, 2024)
K240066 — Fine Osteotomy (February 9, 2024)