Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Artimplant AB — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
331 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071887 | SPORTMESH OR ARTELON TISSUE REINFORCEMENT | Artimplant AB | 2007-09-18 | 71 | 0 |
| K061956 | ARTELON STT SPACER | Artimplant AB | 2007-06-07 | 331 | 0 |
| K061954 | ARTELON CMC SPACER ARTHRO | Artimplant AB | 2007-06-01 | 325 | 0 |
| K052830 | SPORTMESH | Artimplant AB | 2006-01-19 | 106 | 0 |
| K052482 | ARTELON SURGICAL SUTURE | Artimplant AB | 2005-10-17 | 38 | 0 |
| K040070 | ARTELON SPACER CMC-1 | Artimplant AB | 2004-09-21 | 251 | 0 |
| K032160 | ARTELON SURGICAL SUTURE | Artimplant AB | 2003-11-17 | 125 | 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