Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rotation Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
180 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140300 | COLLAGEN TENDON SHEET-DDI (CTS-DDI) | Rotation Medical, Inc. | 2014-03-26 | 48 | 0 |
| K131635 | ROTATION MEDICAL BONE STAPLE (RMB STAPLE) | Rotation Medical, Inc. | 2013-08-29 | 86 | 0 |
| K131637 | ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) | Rotation Medical, Inc. | 2013-07-12 | 38 | 2 |
| K122048 | COLLAGEN TENDON SHEET-D | Rotation Medical, Inc. | 2013-01-08 | 180 | 0 |
| K112423 | COLLAGEN TENDON SHEET | Rotation Medical, Inc. | 2011-12-22 | 121 | 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