Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Custom Orthopaedic Solutions, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
136 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162697 | Arthrex Glenoid Intelligent Reusable Instrument System, Arth | Custom Orthopaedic Solutions, Inc. | 2017-02-10 | 136 | 0 |
| K153612 | ArthrexVIP Web Portal | Custom Orthopaedic Solutions, Inc. | 2016-03-15 | 89 | 0 |
| K153215 | SmartBase for Arthrex Glenoid IRIS | Custom Orthopaedic Solutions, Inc. | 2016-02-19 | 106 | 0 |
| K151501 | OrthoVis Web Portal | Custom Orthopaedic Solutions, Inc. | 2015-10-02 | 120 | 0 |
| K151568 | Arthrex OrthoVis Preoperative Plan | Custom Orthopaedic Solutions, Inc. | 2015-07-31 | 51 | 0 |
| K142072 | GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS | Custom Orthopaedic Solutions, Inc. | 2014-11-24 | 124 | 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