Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EZX — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
705 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063461 | ANOVA CONTAINMENT DEVICE | Anova Corporation | 2009-08-13 | 1002 | 0 |
| K014200 | OPTIMESH | Spineology, Inc. | 2003-11-26 | 705 | 0 |
| K032344 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10 | Implex Corp. | 2003-10-02 | 64 | 0 |
| K032282 | MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYS | Implex Corp. | 2003-08-21 | 28 | 0 |
| K024169 | MACROPORE OS RECONSTRUCTION | Macropore Biosurgery, Inc. | 2003-07-01 | 195 | 0 |
| K023882 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | Implex Corp. | 2003-02-19 | 90 | 0 |
| K020853 | NUVASIVE MESH | Nuvasive, Inc. | 2002-06-13 | 90 | 0 |
| K983766 | SYNTHES SYNMESH | Synthes (Usa) | 1998-12-18 | 53 | 0 |
| K945027 | TROCHANTER MESH | Acu Med, Inc. | 1995-02-01 | 111 | 0 |
| K900138 | MOTECH TITANIUM SURGICAL MESH | Biedermann Motech GmbH | 1990-03-20 | 68 | 0 |
| K896369 | TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM | Techmedica, Inc. | 1989-11-24 | 18 | 0 |
| K890601 | STUART TITANIUM SURGICAL MESH | Stuart | 1989-03-16 | 38 | 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