Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
269 daysmedian FDA review time
487 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192745 | DePuy Synthes Trauma Screws | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2019-11-26 | 57 | 0 |
| K181933 | DePuy Synthes Sterilization Container System | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2019-05-09 | 294 | 0 |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2018-11-01 | 269 | 0 |
| K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – M | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2018-06-21 | 267 | 0 |
| K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditio | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2017-06-30 | 487 | 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