Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mtp Solutions, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140970 | ONE-PIECE PEEK FUSION IMPLANT | Mtp Solutions, LLC | 2014-05-13 | 27 | 0 |
| K133235 | THREADED PEEK K-WIRE | Mtp Solutions, LLC | 2014-04-07 | 168 | 0 |
| K133515 | PEEK FUSION IMPLANT | Mtp Solutions, LLC | 2014-03-28 | 133 | 0 |
| K133229 | TITANIUM SUTURE ANCHOR | Mtp Solutions, LLC | 2014-01-30 | 101 | 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