KWS
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- Advisory panel
- Orthopedic
- Total cleared
- 190
Adverse events under product code KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KWS
1–100 of 190- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K252418 — Catalyst F1x Shoulder System
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
- K241292 — MyShoulder Planner (5.3SSWPL)
- K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
- K241609 — Tornier Humeral Reconstruction System (Tornier HRS)
- K230513 — Arthrex Univers Apex OptiFit Humeral Stem
- K222592 — AltiVate® Anatomic Shoulder AG e+ with Markers
- K230572 — AETOS Shoulder System
- K220847 — AETOS Shoulder System
- K222317 — Catalyst EA Convertible Stemmed Shoulder
- K213387 — AltiVate® Anatomic Shoulder AG e+ with Markers
- K213785 — SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
- 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)
- K212356 — Exactech® Equinoxe® Laser Cage Glenoid
- K212435 — Comprehensive Humeral Fracture Positioning Sleeves
- K210861 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K210050 — Augmented VaultLock Glenoid
- K203315 — BLUEPRINT Patient Specific Instrumentation
- K203230 — Global Shoulder and Delta CTA systems
- K203026 — AltiVate® Anatomic Pegged Glenoid with Markers
- K202289 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K193180 — Alliance Augmented Glenoid
- K191247 — SmartSPACE Shoulder System
- K191814 — Alliance Glenoid
- K190286 — Materialise Glenoid Positioning System
- K191318 — AEQUALIS FLEX REVIVE Shoulder System
- K190521 — Aequalis Ascend Flex Shoulder System
- K190290 — AltiVate Reverse Humeral Stem, 48mm
- K182799 — Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
- K183039 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K183042 — SMR Lateralized Connectors with screws
- K181555 — Arthrex Fracture Adapter Hemi Shoulder Prosthesis
- K181742 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K181420 — Aequalis Flex Revive Shoulder System
- K171841 — Arthrex Shoulder System
- K172054 — Materialise Glenoid Positioning System
- K172351 — AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
- K172210 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K170910 — Medacta Anatomic Shoulder Prosthesis
- K170893 — Materialise Glenoid Positioning System
- K162800 — BLUEPRINT Patient Specific Instrumentation
- K162697 — Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal
- K161789 — BLUEPRINT Patient Specific Instrumentation
- K161863 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
- K162024 — AltiVate Anatomic Shoulder System
- K161108 — Arthrex VaultLock Glenoid
- K160555 — BLUEPRINT Patient Specific Instrumentation
- K160975 — Aequalis PerFORM+ Shoulder System
- K153602 — Materialise Glenoid Positioning System
- K153722 — SMR 3-Pegs Glenoids
- K160085 — Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
- K153215 — SmartBase for Arthrex Glenoid IRIS
- K152047 — INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
- K152267 — Remedy® Shoulder Spacer
- K153115 — Arthrex Univers Apex, Size 5 Stem
- K151500 — Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)
- K151293 — Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
- K143256 — SMR Modular Glenoid
- K150583 — Aequalis PerFORM+ Shoulder System
- K143374 — BLUEPRINT Patient Specific Instrumentation
- K142072 — GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
- K142403 — Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
- K142413 — TITAN Modular Total Shoulder System
- K133349 — SMR TT METAL BACK GLENOID
- K133834 — DEPUY GLOBAL UNITE SHOULDER SYSTEM
- K140063 — EQUINOXE EXTRA SHORT HUMERAL HEAD
- K133462 — DUOCENTRIC REVERSED SHOULDER PROSTHESIS
- K130048 — REVERSE SHOULDER PROSTHESIS MONOBLOCK
- K131559 — MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
- K131633 — ARTHREX UNIVERS APEX
- K131277 — SEVIIN FRACTURE SHOULDER
- K131129 — CAS PSI SHOULDER
- K130050 — TITAN REVERSE SHOULDER SYSTEM
- K130642 — SMR 3-PEGS GLENOIDS
- K131112 — LIMACORPORATE SMR CTA HUMERAL HEADS
- K130129 — UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
- K123122 — GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
- K123982 — TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
- K122698 — AEQUALIS ASCEND FLEX SHOULDER SYSTEM
- K121220 — EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
- K121493 — ASCEND SHOULDER SYSTEM
- K120794 — ASCEND SHOULDER SYSTEM
- K112438 — TITAN MODULAR TOTAL SHOULDER SYSTEM
- K113413 — ASCEND SHOULDER SYSTEM
- K120044 — ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED
- K113012 — PROMOS MODULAR SHOULDER SYSTEM
- K113309 — EXACTECH EQUINOXE CAGE GLENOIDS
- K111902 — AEQUALIS SHOULDER SYSTEM
- K111212 — SMR SHOULDER SYSTEM- REVISION STEMS
- K110847 — SMR SHOULDER SYSTEM - CTA HUMERAL HEADS
- K111596 — TOTAL SHOULDER SYSTEM
- K111379 — EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
- K110905 — TOTAL SHOULDER SYSTEM
- 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
- K110865 — AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
- K102924 — AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
- K102670 — TOTAL SHOULDER SYSTEM
- K103466 — ARTHREX UNIVERS II SHOULDER PROSTHESIS
- K103419 — EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
Data sourced from openFDA. This site is unofficial and independent of the FDA.