Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KWT — Predicate Candidate Screening
71 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
254 days90th percentile
71clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Steml | Exactech, Inc. | 2025-12-01 | 266 | 0 |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. | 2025-10-30 | 150 | 1 |
| K241944 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2025-03-10 | 251 | 0 |
| K241817 | InSet Total Shoulder System | Shoulder Innovations, Inc. | 2025-02-11 | 232 | 0 |
| K231657 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2024-02-16 | 254 | 0 |
| K223631 | Comprehensive Segmental Revision System(SRS) | Biomet Orthopedics | 2023-07-12 | 219 | 0 |
| K222482 | AGILON XO Shoulder System | Implantcast GmbH | 2022-09-28 | 42 | 0 |
| K210899 | LINK Embrace Shoulder System- Anatomical Configuration | Waldemar Link GmbH & Co. KG | 2021-06-21 | 87 | 0 |
| K191698 | TiN Coated Humeral Head | Fx Shoulder USA, Inc. | 2020-07-16 | 387 | 0 |
| K192365 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | 2019-11-29 | 91 | 0 |
| K191811 | Catalyst OrthoScience CSR Shoulder System | Catalyst Orthoscience, Inc. | 2019-09-11 | 68 | 0 |
| K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-06-05 | 90 | 0 |
| K182500 | Catalyst CSR Press-Fit Humeral Components | Catalyst Orthoscience, Inc. | 2019-01-11 | 121 | 0 |
| K181287 | Catalyst CSR Shoulder System | Catalyst Orthoscience, Inc. | 2018-07-12 | 57 | 0 |
| K173812 | Catalyst CSR 3 Peg Glenoids | Catalyst Orthoscience, Inc. | 2018-03-09 | 84 | 0 |
| K162903 | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Sm | Exactech, Inc. | 2017-02-27 | 133 | 0 |
| K161476 | SMR Shoulder System | Lima Corporate S.P.A. | 2016-06-24 | 28 | 0 |
| K152825 | Catalyst CSR Shoulder System | Catalyst Orthoscience, LLC | 2016-05-11 | 225 | 0 |
| K150730 | Zimmer PSI Shoulder System | Zimmer | 2015-06-16 | 88 | 0 |
| K143659 | Equinoxe Mega Prosthesis | Exactech, Inc. | 2015-04-09 | 107 | 0 |
| K140071 | HUMELOCK II CEMENTED SHOULDER SYSTEM | Fx Solutions | 2014-07-28 | 196 | 0 |
| K123814 | HUMELOCK II CEMENTED SHOULDER SYSTEM | Fx Solutions | 2013-08-13 | 244 | 0 |
| K121543 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES | Zimmer, Inc. | 2012-10-11 | 139 | 0 |
| K111746 | COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) | Biomet, Inc. | 2011-12-15 | 177 | 1 |
| K110791 | BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION | Zimmer, Inc. | 2011-09-02 | 165 | 1 |
| K110706 | EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD | Exactech, Inc. | 2011-05-17 | 64 | 0 |
| K103404 | ANA0TOMICAL SHOULDER TM COMBINED SYSTEM | Zimmer GmbH | 2011-03-15 | 116 | 1 |
| K101263 | LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LT | Lima-Lto S.P.A. | 2011-01-28 | 268 | 0 |
| K100858 | LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR S | Lima-Lto S.P.A. | 2010-12-10 | 259 | 2 |
| K071147 | NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM | Nexa Orthopedics, Inc. | 2007-07-20 | 87 | 0 |
| K050761 | ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM | Zimmer, Inc. | 2005-04-11 | 18 | 6 |
| K043505 | DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM | Biomet, Inc. | 2005-02-09 | 51 | 0 |
| K042321 | MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUME | Biomet Manufacturing Corp | 2005-01-28 | 155 | 0 |
| K041549 | ZIMMER TRABECULAR METAL HUMERAL STEM | Zimmer, Inc. | 2004-09-01 | 84 | 8 |
| K032507 | INTERLOK BIO-MODULAR HUMERAL STEMS | Biomet, Inc. | 2003-09-05 | 22 | 0 |
| K030710 | BIO-MODULAR SHOULDER SYSTEM | Biomet, Inc. | 2003-06-04 | 90 | 1 |
| K023063 | COMPREHENSIVE HUMERAL FRACTURE SYSTEM | Biomet Orthopedics, Inc. | 2002-12-13 | 88 | 1 |
| K022377 | THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SH | Implex Corp. | 2002-12-10 | 141 | 8 |
| K022079 | SHORT AND LONG SOFT TISSUE ATTACHMENT | Biomet, Inc. | 2002-09-24 | 90 | 0 |
| K020045 | 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM | Biomet Orthopedics, Inc. | 2002-01-30 | 23 | 0 |
| K014049 | EPOCA CODR STEM AND HEAD | Stelkast Company | 2002-01-09 | 30 | 0 |
| K010869 | EPOCA CUSTOM OFFSET SHOULDER SYSTEM | Argomedical AG | 2001-10-11 | 202 | 0 |
| K002998 | BIOMET BI-POLAR SHOULDER SYSTEM | Biomet, Inc. | 2000-10-06 | 10 | 1 |
| K991585 | BIPOLAR SHOULDER PROSTHESIS | Biomet, Inc. | 1999-08-18 | 103 | 0 |
| K991603 | GRIT BLASTED HUMERAL STEM | Encore Orthopedics, Inc. | 1999-06-29 | 50 | 0 |
| K984541 | GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD | DePuy Orthopaedics, Inc. | 1999-01-14 | 24 | 0 |
| K982981 | NEW ZIMMER SHOULDER SYSTEM | Zimmer, Inc. | 1998-12-17 | 113 | 0 |
| K970567 | SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS | Intermedics Orthopedics | 1997-02-27 | 14 | 0 |
| K962315 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | Intermedics Orthopedics | 1996-09-03 | 78 | 0 |
| K960424 | BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) N | Endotec, Inc. | 1996-08-26 | 210 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda