FDA Product Code
FDA Product Code KWS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3660
510(k) Clearances — 191 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260721 | Tornier Perform Advanced Glenoid | Tornier, Inc. | 2026-07-22 | Traditional | PDF ↗ |
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | 2026-04-06 | Traditional | PDF ↗ |
| K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2025-11-06 | Traditional | PDF ↗ |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | 2025-10-29 | Traditional | PDF ↗ |
| K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International S.A. | 2025-01-30 | Traditional | PDF ↗ |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | Stryker Corporation (Tornier, Inc.) | 2024-12-06 | Traditional | PDF ↗ |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) | 2024-09-10 | Traditional | PDF ↗ |
| K230513 | Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. | 2023-09-26 | Traditional | PDF ↗ |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with Markers | Encore Medical L.P. | 2023-06-23 | Abbreviated | PDF ↗ |
| K230572 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-07 | Traditional | PDF ↗ |
| K220847 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-01-03 | Traditional | PDF ↗ |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | 2022-11-10 | Traditional | PDF ↗ |
| K213387 | AltiVate® Anatomic Shoulder AG e+ with Markers | Encore Medical L.P. | 2022-07-07 | Traditional | PDF ↗ |
| K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | Limacorporate | 2022-05-13 | Special | PDF ↗ |
| K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) | Smith & Nephew, Inc. | 2022-03-11 | Traditional | PDF ↗ |
| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | 2022-03-04 | Traditional | PDF ↗ |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | Biomet, Inc. | 2021-12-10 | Traditional | PDF ↗ |
| K210861 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH | 2021-09-03 | Traditional | PDF ↗ |
| K210050 | Augmented VaultLock Glenoid | Arthrex, Inc. | 2021-06-07 | Traditional | PDF ↗ |
| K203315 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2021-04-15 | Traditional | PDF ↗ |
| K203230 | Global Shoulder and Delta CTA systems | Depuy Lnc. | 2021-04-02 | Traditional | PDF ↗ |
| K203026 | AltiVate® Anatomic Pegged Glenoid with Markers | Encore Medical L.P. | 2020-12-23 | Traditional | PDF ↗ |
| K202289 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH | 2020-12-16 | Traditional | PDF ↗ |
| K193180 | Alliance Augmented Glenoid | Zimmer, Inc. | 2020-02-24 | Traditional | PDF ↗ |
| K191247 | SmartSPACE Shoulder System | Techmah Medical, LLC | 2019-11-15 | Traditional | PDF ↗ |
| K191814 | Alliance Glenoid | Zimmer, Inc. | 2019-10-23 | Traditional | PDF ↗ |
| K190286 | Materialise Glenoid Positioning System | Materialise NV | 2019-07-08 | Traditional | PDF ↗ |
| K191318 | AEQUALIS FLEX REVIVE Shoulder System | Tornier, Inc. | 2019-06-14 | Special | PDF ↗ |
| K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019-06-12 | Special | PDF ↗ |
| K190290 | AltiVate Reverse Humeral Stem, 48mm | Encore Medical L.P. | 2019-04-26 | Special | PDF ↗ |
| K182799 | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads | Arthrex, Inc. | 2019-03-08 | Traditional | PDF ↗ |
| K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH | 2019-02-15 | Traditional | PDF ↗ |
| K183042 | SMR Lateralized Connectors with screws | Lima Corporate S.P.A. | 2019-01-25 | Traditional | PDF ↗ |
| K181555 | Arthrex Fracture Adapter Hemi Shoulder Prosthesis | Arthrex, Inc. | 2018-12-21 | Traditional | PDF ↗ |
| K181742 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH | 2018-09-27 | Traditional | PDF ↗ |
| K181420 | Aequalis Flex Revive Shoulder System | Tornier, Inc. | 2018-09-20 | Traditional | PDF ↗ |
| K171841 | Arthrex Shoulder System | Arthrex, Inc. | 2018-03-29 | Traditional | PDF ↗ |
| K172054 | Materialise Glenoid Positioning System | Materialise NV | 2017-11-03 | Traditional | PDF ↗ |
| K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert | Encore Medical L.P. | 2017-10-30 | Traditional | PDF ↗ |
| K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker Trauma AG | 2017-10-02 | Traditional | PDF ↗ |
| K170910 | Medacta Anatomic Shoulder Prosthesis | Medacta International S.A. | 2017-08-16 | Traditional | PDF ↗ |
| K170893 | Materialise Glenoid Positioning System | Materialise NV | 2017-06-19 | Traditional | PDF ↗ |
| K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017-02-22 | Traditional | PDF ↗ |
| K162697 | Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal | Custom Orthopaedic Solutions, Inc. | 2017-02-10 | Traditional | PDF ↗ |
| K161789 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016-12-27 | Traditional | PDF ↗ |
| K161863 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) | Stryker GmbH | 2016-11-23 | Traditional | PDF ↗ |
| K162024 | AltiVate Anatomic Shoulder System | Encore Medical L.P. | 2016-11-21 | Traditional | PDF ↗ |
| K161108 | Arthrex VaultLock Glenoid | Arthrex, Inc. | 2016-08-29 | Special | PDF ↗ |
| K160975 | Aequalis PerFORM+ Shoulder System | Tornier, Inc. | 2016-06-10 | Special | PDF ↗ |
| K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016-06-10 | Special | PDF ↗ |
| K153602 | Materialise Glenoid Positioning System | Materialise NV | 2016-04-26 | Traditional | PDF ↗ |
| K153722 | SMR 3-Pegs Glenoids | Lima Corporate S.P.A. | 2016-04-06 | Traditional | PDF ↗ |
| K160085 | Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System | Zimmer GmbH | 2016-03-08 | Special | PDF ↗ |
| K153215 | SmartBase for Arthrex Glenoid IRIS | Custom Orthopaedic Solutions, Inc. | 2016-02-19 | Traditional | PDF ↗ |
| K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid | Ascension Orthopedics | 2015-12-23 | Traditional | PDF ↗ |
| K152267 | Remedy® Shoulder Spacer | Osteoremedies, LLC | 2015-12-15 | Traditional | PDF ↗ |
| K153115 | Arthrex Univers Apex, Size 5 Stem | Arthrex, Inc. | 2015-11-23 | Special | PDF ↗ |
| K151500 | Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) | Custom Orthopaedic Solutions | 2015-10-05 | Traditional | PDF ↗ |
| K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015-09-24 | Special | PDF ↗ |
| K143256 | SMR Modular Glenoid | Lima Corporate S.P.A. | 2015-05-28 | Special | PDF ↗ |
| K150583 | Aequalis PerFORM+ Shoulder System | Tornier, Inc. | 2015-04-23 | Special | PDF ↗ |
| K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015-04-08 | Traditional | PDF ↗ |
| K142072 | GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) | Custom Orthopaedic Solutions, Inc. | 2014-11-24 | Traditional | PDF ↗ |
| K142403 | Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System | Zimmer GmbH | 2014-11-24 | Traditional | PDF ↗ |
| K142413 | TITAN Modular Total Shoulder System | Ascension Orthopedics | 2014-11-14 | Traditional | PDF ↗ |
| K133349 | SMR TT METAL BACK GLENOID | Lima Corporate S.P.A. | 2014-06-03 | Traditional | PDF ↗ |
| K133834 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | Depuy(Ireland) | 2014-04-03 | Traditional | PDF ↗ |
| K140063 | EQUINOXE EXTRA SHORT HUMERAL HEAD | Exactech, Inc. | 2014-02-11 | Special | PDF ↗ |
| K133462 | DUOCENTRIC REVERSED SHOULDER PROSTHESIS | Aston Medical | 2014-02-07 | Traditional | PDF ↗ |
| K130048 | REVERSE SHOULDER PROSTHESIS MONOBLOCK | Encore Medical L.P. | 2013-10-29 | Traditional | PDF ↗ |
| K131559 | MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES | Materialise NV | 2013-09-27 | Traditional | PDF ↗ |
| K131633 | ARTHREX UNIVERS APEX | Arthrex, Inc. | 2013-09-27 | Traditional | PDF ↗ |
| K131277 | SEVIIN FRACTURE SHOULDER | Ingen Orthopedics, LLC | 2013-08-28 | Traditional | PDF ↗ |
| K131129 | CAS PSI SHOULDER | Zimmer Cas | 2013-08-20 | Traditional | PDF ↗ |
| K130050 | TITAN REVERSE SHOULDER SYSTEM | Ascension Orthopedic | 2013-06-18 | Traditional | PDF ↗ |
| K130642 | SMR 3-PEGS GLENOIDS | Lima Corporate S.P.A. | 2013-06-12 | Traditional | PDF ↗ |
| K131112 | LIMACORPORATE SMR CTA HUMERAL HEADS | Lima Corporate S.P.A. | 2013-06-07 | Special | PDF ↗ |
| K130129 | UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM | Arthrex, Inc. | 2013-05-31 | Traditional | PDF ↗ |
| K123122 | GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) | Cleveland Clinic | 2013-04-05 | Traditional | PDF ↗ |
| K123982 | TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ | Encore Medical L.P. | 2013-01-23 | Special | PDF ↗ |
| K122698 | AEQUALIS ASCEND FLEX SHOULDER SYSTEM | Tornier S.A.S. | 2013-01-08 | Traditional | PDF ↗ |
| K121220 | EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT | Exactech, Inc. | 2012-11-20 | Special | PDF ↗ |
| K121493 | ASCEND SHOULDER SYSTEM | Tornier, Inc. | 2012-06-20 | Special | PDF ↗ |
| K120794 | ASCEND SHOULDER SYSTEM | Tornier, Inc. | 2012-04-13 | Special | PDF ↗ |
| K112438 | TITAN MODULAR TOTAL SHOULDER SYSTEM | Ascension Orthopedic | 2012-04-11 | Special | PDF ↗ |
| K113413 | ASCEND SHOULDER SYSTEM | Tornier, Inc. | 2012-03-09 | Special | PDF ↗ |
| K120044 | ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED | Arthrex, Inc. | 2012-03-08 | Special | PDF ↗ |
| K113012 | PROMOS MODULAR SHOULDER SYSTEM | Smith & Nephew, Inc. | 2012-01-05 | Traditional | PDF ↗ |
| K113309 | EXACTECH EQUINOXE CAGE GLENOIDS | Exactech, Inc. | 2011-12-08 | Special | PDF ↗ |
| K111902 | AEQUALIS SHOULDER SYSTEM | Tornier | 2011-11-03 | Traditional | PDF ↗ |
| K111212 | SMR SHOULDER SYSTEM- REVISION STEMS | Lima Corporate S.P.A. | 2011-07-28 | Traditional | PDF ↗ |
| K110847 | SMR SHOULDER SYSTEM - CTA HUMERAL HEADS | Lima Corporate S.P.A. | 2011-07-15 | Traditional | PDF ↗ |
| K111596 | TOTAL SHOULDER SYSTEM | Shoulder Innovations, LLC | 2011-07-05 | Special | PDF ↗ |
| K111379 | EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT | Exactech, Inc. | 2011-06-08 | Special | PDF ↗ |
| K110905 | TOTAL SHOULDER SYSTEM | Shoulder Innovations, LLC | 2011-05-24 | Special | PDF ↗ |
| K103835 | REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N | Howmedica Osteonics Corp. | 2011-05-05 | Traditional | PDF ↗ |
| K110865 | AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM | Tornier, Inc. | 2011-04-27 | Special | PDF ↗ |
| K102924 | AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM | Tornier, Inc. | 2011-01-31 | Traditional | PDF ↗ |
| K102670 | TOTAL SHOULDER SYSTEM | Shoulder Innovations, LLC | 2011-01-24 | Traditional | PDF ↗ |
| K103466 | ARTHREX UNIVERS II SHOULDER PROSTHESIS | Arthrex, Inc. | 2010-12-22 | Special | PDF ↗ |
Product code KWS · Class II · Orthopedic. Data: openFDA.