Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Synthes — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
145 daysmedian FDA review time
285 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123723 | SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM | Synthes | 2013-09-05 | 275 | 0 |
| K122455 | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERN | Synthes | 2013-04-11 | 241 | 2 |
| K113071 | SYNTHECEL DURA REPLACEMENT DEVICES | Synthes | 2012-01-09 | 84 | 0 |
| K110604 | VBB SYSTEM | Synthes | 2011-12-13 | 285 | 1 |
| K093772 | SYNTHES STERNAL FIXATION SYSTEM | Synthes | 2010-03-29 | 111 | 0 |
| K013072 | CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) | Synthes | 2002-11-26 | 439 | 0 |
| K020602 | SYNTHES PILON PLATE | Synthes | 2002-05-20 | 87 | 0 |
| K010108 | USS-LINE EXTENSION | Synthes | 2001-06-06 | 145 | 0 |
| K003836 | SYNTHES SYNEX SPACER SYSTEM | Synthes | 2001-05-29 | 168 | 11 |
| K003061 | SYNTHES USS (10.0MM SIDE OPENING SCREWS) | Synthes | 2000-10-30 | 28 | 0 |
| K982732 | SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS) | Synthes | 1998-10-08 | 64 | 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