Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PKC · Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
167 daysmedian FDA review time
274 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254154 | FX V135 EASYTECH® Shoulder System | FX Shoulder Solutions, Inc. | 2026-05-01 | 130 | 0 |
| K252129 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | 2025-10-03 | 88 | 0 |
| K243248 | INHANCE INTACT™ | Depuy Ireland UC | 2024-12-23 | 73 | 0 |
| K241873 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2024-12-11 | 167 | 0 |
| K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | 2024-11-20 | 250 | 0 |
| K221758 | SMR Stemless Anatomic | Lima Corporate S.P.A. | 2023-03-17 | 274 | 0 |
| K220418 | Tornier Perform Humeral System – Stemless | Tornier, Inc. | 2022-09-14 | 212 | 1 |
| K213615 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | 2022-03-11 | 116 | 0 |
| K212683 | GLOBAL ICON Stemless Shoulder System | Depuy(Ireland) | 2022-01-19 | 148 | 0 |
| K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021-07-16 | 274 | 0 |
| K201391 | Easytech® Anatomical Shoulder System | Fx Shoulder USA, Inc. | 2021-02-16 | 265 | 0 |
| K203100 | Arthrex Eclipse Titanium Humeral Head | Arthrex, Inc. | 2020-11-20 | 37 | 0 |
| K201542 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | 2020-07-08 | 29 | 0 |
| K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | Encore Medical L.P. | 2020-06-03 | 194 | 0 |
| K192097 | Exactech® Equinoxe® Stemless Humeral Components | Exactech, Inc. | 2020-04-29 | 268 | 0 |
| K182516 | Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp | 2019-04-22 | 221 | 0 |
| K173388 | Exactech Equinoxe Stemless Shoulder | Exactech, Inc. | 2018-03-09 | 130 | 0 |
| K171858 | Sidus Stem-Free Shoulder | Zimmer GmbH | 2017-12-18 | 180 | 0 |
| K143552 | Simpliciti Shoulder System | Tornier, Inc. | 2015-03-04 | 79 | 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