Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HSD — Predicate Candidate Screening
71 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
242 days90th percentile
71clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233260 | Univers Revers CA Head and Adapter | Arthrex, Inc. | 2024-02-12 | 136 | 0 |
| K221232 | Univers Revers Humeral Cup Implant | Arthrex, Inc. | 2022-05-19 | 20 | 0 |
| K191433 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2020-11-12 | 533 | 0 |
| K193122 | Biocore9 Humeral Resurfacing System | Biocore9, LLC | 2020-05-15 | 185 | 0 |
| K173964 | OVOMotion Shoulder Arthroplasty System | Arthrosurface, Inc. | 2018-04-18 | 110 | 0 |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2016-11-21 | 145 | 0 |
| K161620 | Anatomical Shoulder Domelock Dome centric | Zimmer GmbH | 2016-11-01 | 141 | 0 |
| K151527 | Arthrex Univers Revers CA Heads and Adapters | Arthrex, Inc. | 2016-04-19 | 316 | 0 |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | Arthrosurface, Inc. | 2014-12-19 | 66 | 0 |
| K131298 | EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM | Exactech, Inc. | 2013-11-26 | 204 | 0 |
| K130759 | HUMELOCK II CEMENTLESS SHOULDER SYSTEM | Fx Solutions | 2013-11-09 | 234 | 0 |
| K130675 | ARTHREX UNIVERS II CA HEADS | Arthrex, Inc. | 2013-10-30 | 231 | 0 |
| K130635 | SEVIIN SURFACE REPLACEMENT SHOULDER | Ingen Orthopedics, LLC | 2013-08-26 | 168 | 0 |
| K121714 | SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS | Smith & Nephew, Inc. | 2012-09-07 | 88 | 0 |
| K112900 | SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL | Lima Corporate S.P.A. | 2012-06-01 | 242 | 0 |
| K112983 | SPACER-S | Tecres S.P.A. | 2011-12-12 | 67 | 0 |
| K111097 | HUMELOCK CEMENTED SHOULDER PROSTHESIS | Fx Solutions | 2011-11-09 | 203 | 0 |
| K082715 | DEPUY GLOBAL AP CTA HUMERAL HEAD | DePuy Orthopaedics, Inc. | 2008-12-18 | 92 | 0 |
| K080990 | DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER | DePuy Orthopaedics, Inc. | 2008-08-08 | 123 | 0 |
| K073331 | DVO EXTENDED ARTICULATION HUMERAL HEADS | Dvo Extremity Solutions, LLC | 2008-02-19 | 84 | 0 |
| K072578 | SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM | Synthes (Usa) | 2007-11-28 | 76 | 0 |
| K071064 | ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/H | Ascension Orthopedics, Inc. | 2007-06-22 | 67 | 0 |
| K070963 | REUNION HA FRACTURE STEM | Howmedica Osteonics Corp. | 2007-05-04 | 29 | 1 |
| K063578 | PROMOS MODULAR SHOULDER SYSTEM | Plus Orthopedics AG | 2007-03-02 | 92 | 4 |
| K062661 | AEQUALIS RESURFACING HEAD | Tornier | 2006-12-22 | 106 | 0 |
| K062845 | MODULAR REPLACEMENT ELBOW SYSTEM | Howmedica Osteonics Corp. | 2006-12-13 | 82 | 0 |
| K063081 | AEQUALIS SHOULDER SYSTEM | Tornier | 2006-11-09 | 30 | 0 |
| K062861 | ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM | Ascension Orthopedics, Inc. | 2006-10-31 | 36 | 0 |
| K061862 | AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM | Axiom Orthopaedics, Inc. | 2006-08-28 | 59 | 0 |
| K061677 | SOLAR PUREFIX HA SHOULDER | Howmedica Osteonics Corp. | 2006-07-10 | 25 | 1 |
| K061454 | EXACTECH EQUINOXE SHOULDER STEMS | Exactech, Inc. | 2006-06-12 | 18 | 0 |
| K060535 | SPACER-S TEMPORARY SHOULDER SPACER | Tecres S.P.A. | 2006-05-24 | 85 | 0 |
| K051843 | COPELAND EAS HUMERAL RESURFACING HEADS | Biomet, Inc. | 2005-09-29 | 84 | 0 |
| K040432 | SOLAR 2 ANATOMIC SHOULDER | Stryker Orthopaedics | 2005-01-07 | 323 | 0 |
| K040128 | MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STE | Howmedica Osteonics Corp. | 2004-03-26 | 65 | 0 |
| K032126 | PROMOS SHOULDER | Plus Orthopedics | 2004-01-08 | 182 | 0 |
| K033516 | DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS | DePuy Orthopaedics, Inc. | 2003-12-03 | 26 | 0 |
| K031971 | GLOBAL CAP RESURFACING REPLACEMENT SHOULDER | DePuy Orthopaedics, Inc. | 2003-09-24 | 90 | 0 |
| K032264 | MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM | Howmedica Osteonics Corp. | 2003-08-08 | 16 | 0 |
| K023096 | CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACIN | Std Mfg., Inc. | 2003-04-10 | 204 | 5 |
| K012377 | OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES | Corin USA | 2002-03-11 | 228 | 0 |
| K010827 | COPELAND MB/HA RESURFACING HUMERAL HEADS | Biomet Orthopedics, Inc. | 2001-09-14 | 178 | 0 |
| K010657 | COPELAND MB RESURFACING HUMERAL HEADS | Biomet Manufacturing, Inc. | 2001-09-14 | 192 | 0 |
| K011942 | AEQUALIS PRESS-FIT SHOULDER PROSTHESIS | Tornier | 2001-07-13 | 22 | 0 |
| K010664 | COPELAND RESURFACING HUMERAL HEADS | Biomet Manufacturing, Inc. | 2001-04-05 | 30 | 0 |
| K003044 | COPELAND RESURFACING HEADS | Biomet, Inc. | 2000-12-13 | 75 | 0 |
| K003428 | ISS OFFSET HEADS | Biomet, Inc. | 2000-11-24 | 21 | 0 |
| K001419 | SOLAR SHOULDER OFFSET HUMERAL HEAD | Howmedica Osteonics Corp. | 2000-07-27 | 83 | 0 |
| K992525 | ACUMED MODULAR SHOULDER SYSTEM | Acu Med, Inc. | 2000-02-04 | 191 | 1 |
| K992394 | BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT | Endotec, Inc. | 1999-10-15 | 88 | 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