Devices descending from K031454
146 later devices reach Acumen Surgical Navigation System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | 71 | — |
| +1 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 76 | 2 |
| +1 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 78 | 1 |
| +2 | K162719 | iTotal® Hip Replacement System | Conformis, Inc. | 2017 | 17 | 4 |
| +2 | K152893 | Corin Optimized Positioning System (OPS) | Corin USA | 2016 | 8 | — |
| +2 | K150780 | Acetabular Cup Orientation System | Materialise NV | 2015 | 0 | — |
| +2 | K140596 | NAVIO | Blue Belt Technologies, Inc. | 2014 | 21 | — |
| +2 | K131559 | Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides | Materialise NV | 2013 | 35 | — |
| +2 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | 38 | — |
| +2 | K121936 | Naviopfs | Blue Belt Technologies, Inc. | 2012 | 22 | 2 |
| +2 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 46 | 6 |
| +2 | K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha | Mako Surgical Corp. | 2010 | 11 | 2 |
| +2 | K091998 | Robotic Arm Interactive Orthopedic System-Hip | Mako Surgical Corp. | 2009 | 12 | — |
| +2 | K083644 | Mako Surgical Tactile Guidance System-Hip | Mako Surgical Corp. | 2009 | 13 | — |
| +3 | K202373 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020 | 0 | — |
| +3 | K202484 | Cordera Hip System | Conformis, Inc. | 2020 | 2 | 2 |
| +3 | K192198 | Conformis Hip System | Conformis, Inc. | 2019 | 12 | 1 |
| +3 | K190904 | Conformis BeneFIT Hip System | Conformis, Inc. | 2019 | 6 | 1 |
| +3 | K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Corin USA | 2019 | 5 | — |
| +3 | K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | 10 | — |
| +3 | K181061 | Corin Optimized Positioning System (OPS) Femoral | Corin USA | 2018 | 1 | — |
| +3 | K170584 | Mako Partial Knee Application | Mako Surgical Corp. | 2017 | 2 | 2 |
| +3 | K153602 | Materialise Glenoid Positioning System | Materialise NV | 2016 | 2 | 1 |
| +3 | K142530 | Partial Knee Application (PKA) | Mako Surgical Corporation | 2015 | 3 | — |
| +3 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 44 | 2 |
| +3 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | 31 | — |
| +3 | K143668 | Navio | Blue Belt Technologies, Inc. | 2015 | 20 | — |
| +3 | K121765 | Sculptor Robotic Guidance Arm (Rga) | Stanmore Implants Worldwide, Ltd. | 2013 | 0 | — |
| +3 | K121064 | Makoplasty Total Hip Application, Rio Standard System | Mako Surgical Corporation | 2012 | 9 | 12 |
| +4 | K252067 | Velora Acetabular System | Restor3D, Inc. | 2025 | 0 | — |
| +4 | K242121 | mBôs (Monogram mBôs TKA System) | Monogram Orthopaedics, Inc. | 2025 | 0 | — |
| +4 | K231178 | ACTERA™ hip system | Conformis, Inc. | 2023 | 0 | — |
| +4 | K221104 | Actera™ hip system | Conformis, Inc. | 2022 | 1 | 1 |
| +4 | K220468 | BENCOX Mirabo Cup System | Corentec Co., Ltd. | 2022 | 1 | — |
| +4 | K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2022 | 7 | — |
| +4 | K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint… | Conformis, Inc. | 2021 | 8 | — |
| +4 | K212560 | Signature™ ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2021 | 7 | — |
| +4 | K210121 | ROSA Partial Knee System | Orthosoft D/B/A Zimmer Cas | 2021 | 1 | — |
| +4 | K193545 | Corin Optimized Positioning System (OPS) Femoral | Corin USA | 2020 | 0 | — |
| +4 | K193042 | Optimized Positioning System (OPS) ReView | Corin USA | 2020 | 0 | — |
| +4 | K200615 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2020 | 8 | — |
| +4 | K192656 | Optimized Positioning System (OPS) Insight | Corin USA | 2020 | 3 | — |
| +4 | K190738 | MyShoulder Placement Guides | Medacta International S.A. | 2019 | 4 | — |
| +4 | K192074 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | 9 | — |
| +4 | K172054 | Materialise Glenoid Positioning System | Materialise NV | 2017 | 0 | — |
| +4 | K170893 | Materialise Glenoid Positioning System | Materialise NV | 2017 | 1 | 1 |
| +4 | K170891 | Mako Partial Knee Application | Mako Surgical Corp. | 2017 | 2 | 3 |
| +4 | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 38 | 1 |
| +4 | K161789 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | 0 | — |
| +4 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | 25 | — |
| +4 | K152574 | Navio | Blue Belt Technologies, Inc. | 2015 | 19 | — |
| +4 | K141989 | Makoplasty Total Hip Allpication, Rio Standard System | Mako Surgical Corporation | 2014 | 8 | 3 |
| +5 | K243509 | Archer PSI System | 3D-Side | 2025 | 0 | — |
| +5 | K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2024 | 2 | — |
| +5 | K232425 | Signature™ ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023 | 2 | — |
| +5 | K232533 | ROSA Partial Knee System | Orthosoft D/B/A Zimmer Cas | 2023 | 0 | — |
| +5 | K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | 3 | — |
| +5 | K223223 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2023 | 0 | — |
| +5 | K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2022 | 6 | — |
| +5 | K210653 | ONE Planner Hip | Orthosoft D/B/A Zimmer Cas | 2021 | 0 | — |
| +5 | K202805 | Optimized Positioning System (OPS) Insight | Corin USA | 2020 | 0 | — |
| +5 | K172301 | Mako Partial Knee Application | Mako Surgical Corp. | 2017 | 1 | 6 |
| +5 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 37 | — |
| +5 | K170593 | Mako Total Hip Application | Mako Surgical Corp. | 2017 | 7 | 1 |
| +5 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | 23 | — |
| +5 | K160537 | Navio | Blue Belt Technologies, Inc. | 2016 | 18 | — |
| +6 | K260104 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026 | 1 | — |
| +6 | K241470 | CORE Shoulder System | LinkBio Corp. | 2025 | 0 | 1 |
| +6 | K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2025 | 1 | — |
| +6 | K242373 | Mako Shoulder Application (1.0) | Mako Surgical Corp. | 2024 | 0 | — |
| +6 | K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate… | Conformis, Inc. | 2023 | 2 | — |
| +6 | K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | Conformis, Inc. | 2023 | 2 | — |
| +6 | K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | 1 | — |
| +6 | K231233 | Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS | Conformis, Inc. | 2023 | 0 | 1 |
| +6 | K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate… | Conformis, Inc. | 2023 | 1 | — |
| +6 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | 18 | — |
| +6 | K191247 | SmartSPACE Shoulder System | Techmah Medical, LLC | 2019 | 3 | — |
| +6 | K191998 | Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. | 2019 | 6 | — |
| +6 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | 29 | — |
| +6 | K170360 | NAVIO | Blue Belt Technologies, Inc. | 2017 | 17 | — |
| +7 | K261510 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026 | 0 | — |
| +7 | K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC | 2026 | 0 | — |
| +7 | K251558 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2026 | 0 | — |
| +7 | K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | 2025 | 0 | — |
| +7 | K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International S.A. | 2025 | 0 | — |
| +7 | K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | Arthrex, Inc. | 2024 | 0 | — |
| +7 | K232265 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2024 | 3 | — |
| +7 | K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with… | Conformis, Inc. | 2023 | 0 | — |
| +7 | K230202 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023 | 10 | 1 |
| +7 | K222405 | Smart SPACE Shoulder Planner and 3D Positioners | Lima Corporate S.P.A. | 2022 | 0 | — |
| +7 | K221928 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | 2022 | 8 | — |
| +7 | K220733 | OptiVu ROSA MxR | Orthosoft Inc (D/B/A Zimmer Cas) | 2022 | 1 | — |
| +7 | K213873 | SkyWalker Total Knee System | Microport Navibot International, LLC | 2022 | 0 | — |
| +7 | K213708 | ROSA® Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2022 | 0 | — |
| +7 | K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2022 | 8 | 1 |
| +7 | K211359 | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient… | Tornier, Inc. | 2021 | 8 | 2 |
| +7 | K210998 | ROSA Hip System | Orthosoft D/B/A Zimmer Cas | 2021 | 1 | — |
| +7 | K202151 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2021 | 1 | — |
| +7 | K202454 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2020 | 1 | — |
| +7 | K193515 | Mako Total Knee Application | Mako Surgical Corp. | 2020 | 1 | 6 |