Devices descending from K991585
414 later devices reach Bipolar Shoulder Prosthesis through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +5 | K222482 | AGILON XO Shoulder System | Implantcast GmbH | 2022 | 3 | — |
| +5 | K213856 | Identity Shoulder System | Zimmer, Inc. | 2022 | 4 | — |
| +5 | K220418 | Tornier Perform Humeral System – Stemless | Tornier, Inc. | 2022 | 0 | 1 |
| +5 | K213349 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2022 | 2 | — |
| +5 | K213117 | FX V135 Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2022 | 4 | — |
| +5 | K221232 | Univers Revers Humeral Cup Implant | Arthrex, Inc. | 2022 | 1 | — |
| +5 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 | 7 | — |
| +5 | K212435 | Comprehensive Humeral Fracture Positioning Sleeves | Biomet, Inc. | 2021 | 0 | — |
| +5 | K212415 | Arthrex Modular Glenoid System-Titanium Glenosphere | Arthrex, Inc. | 2021 | 0 | — |
| +5 | K201905 | SMR 140° Reverse Humeral Body | Lima Corporate S.P.A. | 2020 | 0 | — |
| +5 | K191698 | TiN Coated Humeral Head | Fx Shoulder USA, Inc. | 2020 | 0 | — |
| +5 | K193372 | Univers Revers Modular Glenoid System (Augemented baseplates) | Arthrex, Inc. | 2020 | 13 | — |
| +5 | K191960 | Arthrex Univers Revers Modular Glenoid System | Arthrex, Inc. | 2019 | 0 | — |
| +5 | K190588 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2019 | 4 | — |
| +5 | K192365 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | 2019 | 2 | — |
| +5 | K191811 | Catalyst OrthoScience CSR Shoulder System | Catalyst Orthoscience, Inc. | 2019 | 0 | — |
| +5 | K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | Wrightmedicaltechnologyinc | 2019 | 0 | — |
| +5 | K182039 | Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay | Arthrex, Inc. | 2018 | 0 | — |
| +5 | K181742 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System… | Stryker GmbH | 2018 | 9 | — |
| +5 | K181557 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | 2018 | 0 | — |
| +5 | K173717 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2018 | 3 | — |
| +5 | K170414 | Arthrex Univers Revers Apex Humeral Stems | Arthrex, Inc. | 2017 | 1 | — |
| +5 | K162903 | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies | Exactech, Inc. | 2017 | 1 | — |
| +5 | K162697 | Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative… | Custom Orthopaedic Solutions, Inc. | 2017 | 5 | — |
| +5 | K162024 | AltiVate Anatomic Shoulder System | Encore Medical L.P. | 2016 | 34 | 6 |
| +5 | K161620 | Anatomical Shoulder Domelock Dome centric | Zimmer GmbH | 2016 | 3 | — |
| +5 | K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | Biomet, Inc. | 2016 | 3 | 5 |
| +5 | K152754 | Comprehensive Vault Reconstruction System (VRS) | Biomet Manufacturing Corp | 2016 | 22 | 1 |
| +5 | K153115 | Arthrex Univers Apex, Size 5 Stem | Arthrex, Inc. | 2015 | 2 | — |
| +5 | K151500 | Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) | Custom Orthopaedic Solutions | 2015 | 7 | — |
| +5 | K151501 | OrthoVis Web Portal | Custom Orthopaedic Solutions, Inc. | 2015 | 7 | — |
| +5 | K151568 | Arthrex OrthoVis Preoperative Plan | Custom Orthopaedic Solutions, Inc. | 2015 | 20 | — |
| +5 | K150730 | Zimmer PSI Shoulder System | Zimmer | 2015 | 11 | — |
| +5 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | 31 | — |
| +5 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 96 | 2 |
| +5 | K121493 | Ascend Shoulder System | Tornier, Inc. | 2012 | 97 | — |
| +5 | K113309 | Exactech Equinoxe Cage Glenoids | Exactech, Inc. | 2011 | 3 | 8 |
| +5 | K110865 | Aequalis Ascend Modular Anatomic Shoulder System | Tornier, Inc. | 2011 | 0 | — |
| +5 | K103419 | Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM | Exactech, Inc. | 2010 | 22 | 2 |
| +6 | K262955 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2026 | 0 | — |
| +6 | K261683 | Augment Off-Axis Instrument System | Zimmer, Inc. | 2026 | 0 | — |
| +6 | K253992 | Veritas Reverse Total Shoulder System | Restor3D | 2026 | 0 | — |
| +6 | K254154 | FX V135 EASYTECH® Shoulder System | FX Shoulder Solutions, Inc. | 2026 | 0 | — |
| +6 | K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | 2026 | 0 | — |
| +6 | K260104 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026 | 1 | — |
| +6 | K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. | 2025 | 0 | 1 |
| +6 | K250848 | Identity Shoulder System | Zimmer, Inc. | 2025 | 0 | — |
| +6 | K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | Arthrex, Inc. | 2024 | 0 | — |
| +6 | K222592 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2023 | 0 | — |
| +6 | K223801 | FX V135(TM) Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2023 | 2 | — |
| +6 | K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | 3 | — |
| +6 | K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023 | 3 | — |
| +6 | K221968 | StageOne™ Shoulder Cement Spacer Molds | Biomet, Inc. | 2022 | 0 | — |
| +6 | K213387 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2022 | 1 | — |
| +6 | K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | 2022 | 2 | 1 |
| +6 | K211074 | Univers Revers Modular Glenoid System, Standard Augment Baseplates | Arthrex, Inc. | 2021 | 0 | — |
| +6 | K202232 | Comprehensive Vault Reconstruction System | Biomet Manufacturing Corp | 2021 | 0 | — |
| +6 | K202338 | SpaceFlex Shoulder | G21, S.R.L. | 2021 | 1 | — |
| +6 | K203026 | AltiVate® Anatomic Pegged Glenoid with Markers | Encore Medical L.P. | 2020 | 2 | — |
| +6 | K200895 | Univers Revers Modular Glenoid System, Half Augment Baseplate | Arthrex, Inc. | 2020 | 0 | — |
| +6 | K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | Encore Medical L.P. | 2020 | 4 | — |
| +6 | K193523 | ArthrexVIP Web Portal | Arthrex, Inc. | 2020 | 0 | — |
| +6 | K190738 | MyShoulder Placement Guides | Medacta International S.A. | 2019 | 4 | — |
| +6 | K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | 10 | — |
| +6 | K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System… | Stryker GmbH | 2019 | 8 | — |
| +6 | K181999 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2018 | 2 | — |
| +6 | K173073 | AltiVate Anatomic to Reverse Conversion Module | Encore Medical L.P. | 2017 | 3 | — |
| +6 | K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2017 | 15 | 1 |
| +6 | K161789 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | 0 | — |
| +6 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | 25 | — |
| +6 | K153612 | ArthrexVIP Web Portal | Custom Orthopaedic Solutions, Inc. | 2016 | 0 | — |
| +6 | K153215 | SmartBase for Arthrex Glenoid IRIS | Custom Orthopaedic Solutions, Inc. | 2016 | 0 | — |
| +6 | K140082 | Aequalis (TM) Ascent (TM) Flex Shoulder System | Tornier S.A.S. | 2014 | 29 | — |
| +6 | K111379 | Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /… | Exactech, Inc. | 2011 | 21 | 2 |
| +7 | K261510 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026 | 0 | — |
| +7 | K252443 | SpaceFix Shoulder Spacer | G21, S.R.L. | 2025 | 0 | — |
| +7 | K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.P.A. | 2025 | 1 | — |
| +7 | K243509 | Archer PSI System | 3D-Side | 2025 | 0 | — |
| +7 | K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2024 | 2 | — |
| +7 | K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2023 | 0 | — |
| +7 | K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | 1 | — |
| +7 | K212560 | Signature™ ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2021 | 7 | — |
| +7 | K203375 | OVOMotion Reverse Shoulder Arthroplasty System | Arthrosurface, Inc. | 2021 | 0 | — |
| +7 | K202289 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System… | Stryker GmbH | 2020 | 2 | — |
| +7 | K200615 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2020 | 8 | — |
| +7 | K192074 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | 9 | — |
| +7 | K181420 | Aequalis Flex Revive Shoulder System | Tornier, Inc. | 2018 | 4 | — |
| +7 | K173372 | ExactechGPS Total Shoulder Application | Blue Ortho | 2017 | 14 | 1 |
| +7 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | 23 | — |
| +7 | K121220 | Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right | Exactech, Inc. | 2012 | 20 | 2 |
| +8 | K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | Lima Corporate S.P.A. | 2026 | 0 | — |
| +8 | K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2025 | 1 | — |
| +8 | K241609 | Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) | 2024 | 0 | — |
| +8 | K222510 | Blueprint Mixed Reality system | Tornier S.A.S. | 2023 | 0 | 10 |
| +8 | K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2022 | 8 | 1 |
| +8 | K210153 | NextAR RSA Platform | Medacta International S.A. | 2021 | 5 | 1 |
| +8 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | 18 | — |
| +8 | K191247 | SmartSPACE Shoulder System | Techmah Medical, LLC | 2019 | 3 | — |
| +8 | K191318 | AEQUALIS FLEX REVIVE Shoulder System | Tornier, Inc. | 2019 | 3 | 2 |
| +8 | K150583 | Aequalis PerFORM+ Shoulder System | Tornier, Inc. | 2015 | 16 | — |