Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A.M. Surgical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
196 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191771 | SECURE Screw | A.M. Surgical, Inc. | 2019-10-16 | 106 | 0 |
| K191345 | Pegasus System | A.M. Surgical, Inc. | 2019-07-17 | 58 | 0 |
| K180087 | A.M. Surgical Intramedullary Fixation Device | A.M. Surgical, Inc. | 2018-05-18 | 126 | 0 |
| K080133 | MOUNTABLE ENDOSCOPIC BLADE | A.M. Surgical, Inc. | 2008-03-13 | 55 | 0 |
| K042458 | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION | A.M. Surgical, Inc. | 2004-10-07 | 27 | 0 |
| K982142 | MOUNTABLE ENDOSCOPIC KNIFE | A.M. Surgical, Inc. | 1998-12-30 | 196 | 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