Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Synthes (Usa), LLC — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
340 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180821 | TruMatch Graft Cage - Long Bone | Synthes (Usa), LLC | 2018-12-21 | 266 | 0 |
| K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | Synthes USA, LLC | 2016-11-10 | 171 | 0 |
| K152239 | Zero-P Natural Plate System | Synthes (Usa), LLC | 2015-12-02 | 114 | 0 |
| K130146 | SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM | Synthes (Usa), LLC | 2013-05-20 | 118 | 0 |
| K112030 | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM | Synthes USA, LLC | 2012-06-19 | 340 | 1 |
| K120275 | SYNTHES ACIS/VERTEBRAL SPACER CR | Synthes (Usa), LLC | 2012-05-25 | 116 | 0 |
| K101536 | 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM | Synthes (Usa), LLC | 2010-09-15 | 104 | 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