Devices descending from K943462
428 later devices reach Darwin Knee System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +6 | K212992 | LINK® Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021 | 0 | — |
| +6 | K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint… | Conformis, Inc. | 2021 | 8 | — |
| +6 | K212307 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021 | 0 | — |
| +6 | K210790 | Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | 2021 | 1 | — |
| +6 | K210717 | Bone Screws dia. 5,0 mm | Lima Corporate S.P.A. | 2021 | 8 | — |
| +6 | K210899 | LINK Embrace Shoulder System- Anatomical Configuration | Waldemar Link GmbH & Co. KG | 2021 | 0 | — |
| +6 | K210809 | iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) | Conformis, Inc. | 2021 | 4 | 1 |
| +6 | K203421 | Triathlon AS-1 | Conformis, Inc. | 2021 | 0 | — |
| +6 | K210554 | Physica system | Lima Corporate S.P.A. | 2021 | 2 | — |
| +6 | K203697 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021 | 2 | — |
| +6 | K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | 5 | — |
| +6 | K191146 | Humelock TiN Coated Glenosphere | Fx Shoulder USA, Inc. | 2020 | 0 | 1 |
| +6 | K193394 | Humeral Cup Stability & Humeral Cup 135/145o Stability | Fx Shoulder USA, Inc. | 2020 | 3 | — |
| +6 | K192799 | Glenoid Baseplate with Screw | Fx Shoulder USA, Inc. | 2020 | 2 | — |
| +6 | K192206 | 32mm Glenosphere and Humeral Cup | Fx Shoulder USA, Inc. | 2019 | 4 | 1 |
| +6 | K191811 | Catalyst OrthoScience CSR Shoulder System | Catalyst Orthoscience, Inc. | 2019 | 0 | — |
| +6 | K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019 | 12 | — |
| +6 | K182500 | Catalyst CSR Press-Fit Humeral Components | Catalyst Orthoscience, Inc. | 2019 | 2 | — |
| +6 | K181742 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System… | Stryker GmbH | 2018 | 9 | — |
| +6 | K181287 | Catalyst CSR Shoulder System | Catalyst Orthoscience, Inc. | 2018 | 3 | — |
| +6 | K173964 | OVOMotion Shoulder Arthroplasty System | Arthrosurface, Inc. | 2018 | 0 | — |
| +6 | K163669 | Humeris Shoulder | Fx Solutions | 2017 | 20 | — |
| +6 | K162697 | Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative… | Custom Orthopaedic Solutions, Inc. | 2017 | 5 | — |
| +6 | K162455 | Humelock Reversed Shoulder | Fx Solutions | 2017 | 17 | — |
| +6 | K161668 | ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) | Conformis, Inc. | 2016 | 17 | 4 |
| +6 | K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | Conformis, Inc. | 2016 | 18 | — |
| +6 | K151500 | Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) | Custom Orthopaedic Solutions | 2015 | 7 | — |
| +6 | K151501 | OrthoVis Web Portal | Custom Orthopaedic Solutions, Inc. | 2015 | 7 | — |
| +6 | K151568 | Arthrex OrthoVis Preoperative Plan | Custom Orthopaedic Solutions, Inc. | 2015 | 20 | — |
| +6 | K150730 | Zimmer PSI Shoulder System | Zimmer | 2015 | 11 | — |
| +6 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | 31 | — |
| +6 | K111379 | Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /… | Exactech, Inc. | 2011 | 21 | 2 |
| +7 | K261683 | Augment Off-Axis Instrument System | Zimmer, Inc. | 2026 | 0 | — |
| +7 | K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | 2026 | 0 | — |
| +7 | K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | 2025 | 0 | — |
| +7 | K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA… | Encore Medical L.P. | 2025 | 0 | — |
| +7 | K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024 | 1 | — |
| +7 | K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | 2024 | 3 | — |
| +7 | K240278 | Full Wedge Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | 2024 | 0 | — |
| +7 | K234105 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2024 | 0 | — |
| +7 | K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2023 | 0 | — |
| +7 | K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Exactech, Inc. | 2023 | 2 | 1 |
| +7 | K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | Conformis, Inc. | 2023 | 2 | — |
| +7 | K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate… | Conformis, Inc. | 2023 | 1 | — |
| +7 | K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | 3 | — |
| +7 | K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023 | 3 | — |
| +7 | K222317 | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | 2022 | 1 | — |
| +7 | K222936 | Humeris® 135 Shoulder System | Fx Shoulder USA, Inc. | 2022 | 0 | — |
| +7 | K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022 | 2 | 3 |
| +7 | K222482 | AGILON XO Shoulder System | Implantcast GmbH | 2022 | 3 | — |
| +7 | K213117 | FX V135 Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2022 | 4 | — |
| +7 | K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2022 | 7 | — |
| +7 | K211895 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021 | 0 | — |
| +7 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | 5 | — |
| +7 | K201315 | PERFORM Humeral System – Stem | Tornier, Inc. | 2020 | 11 | 1 |
| +7 | K191698 | TiN Coated Humeral Head | Fx Shoulder USA, Inc. | 2020 | 0 | — |
| +7 | K193523 | ArthrexVIP Web Portal | Arthrex, Inc. | 2020 | 0 | — |
| +7 | K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System… | Conformis, Inc. | 2020 | 15 | — |
| +7 | K190738 | MyShoulder Placement Guides | Medacta International S.A. | 2019 | 4 | — |
| +7 | K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | 10 | — |
| +7 | K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System… | Stryker GmbH | 2019 | 8 | — |
| +7 | K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2018 | 17 | 4 |
| +7 | K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2017 | 15 | 1 |
| +7 | K161789 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | 0 | — |
| +7 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | 25 | — |
| +7 | K153612 | ArthrexVIP Web Portal | Custom Orthopaedic Solutions, Inc. | 2016 | 0 | — |
| +7 | K153215 | SmartBase for Arthrex Glenoid IRIS | Custom Orthopaedic Solutions, Inc. | 2016 | 0 | — |
| +7 | K121220 | Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right | Exactech, Inc. | 2012 | 20 | 2 |
| +8 | K254154 | FX V135 EASYTECH® Shoulder System | FX Shoulder Solutions, Inc. | 2026 | 0 | — |
| +8 | K260583 | Equinoxe® Shoulder System | Exactech, Inc. | 2026 | 0 | — |
| +8 | K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2025 | 0 | — |
| +8 | K252129 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | 2025 | 0 | — |
| +8 | K243448 | Equinoxe® Shoulder System | Exactech, Inc. | 2025 | 0 | — |
| +8 | K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.P.A. | 2025 | 1 | — |
| +8 | K243509 | Archer PSI System | 3D-Side | 2025 | 0 | — |
| +8 | K241944 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2025 | 1 | — |
| +8 | K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -… | Stryker Corporation (Tornier, Inc.) | 2024 | 1 | — |
| +8 | K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2024 | 2 | — |
| +8 | K231657 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2024 | 2 | — |
| +8 | K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | 2024 | 1 | — |
| +8 | K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | 1 | — |
| +8 | K223801 | FX V135(TM) Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2023 | 2 | — |
| +8 | K223655 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2023 | 0 | — |
| +8 | K220418 | Tornier Perform Humeral System – Stemless | Tornier, Inc. | 2022 | 0 | 1 |
| +8 | K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2022 | 6 | — |
| +8 | K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | Lima Corporate S.P.A. | 2022 | 2 | 2 |
| +8 | K212560 | Signature™ ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2021 | 7 | — |
| +8 | K211991 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | 3 | — |
| +8 | K203375 | OVOMotion Reverse Shoulder Arthroplasty System | Arthrosurface, Inc. | 2021 | 0 | — |
| +8 | K202289 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System… | Stryker GmbH | 2020 | 2 | — |
| +8 | K191433 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2020 | 3 | — |
| +8 | K200615 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2020 | 8 | — |
| +8 | K192074 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | 9 | — |
| +8 | K173372 | ExactechGPS Total Shoulder Application | Blue Ortho | 2017 | 14 | 1 |
| +8 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | 23 | — |
| +9 | K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | Lima Corporate S.P.A. | 2026 | 0 | — |
| +9 | K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. | 2025 | 0 | 1 |
| +9 | K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2025 | 1 | — |
| +9 | K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | Arthrex, Inc. | 2024 | 0 | — |
| +9 | K232425 | Signature™ ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023 | 2 | — |