Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arthocare Corporation · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
271 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153669 | MultiFIX S Ultra Knotless Fixation System | Arthocare Corporation | 2016-01-19 | 29 | 0 |
| K131182 | MULTIFIX S KNOTLESS FIXATION DEVICE | Arthocare Corporation | 2013-07-29 | 94 | 0 |
| K120791 | AMBIENT TURBOFLASH 90 IFS | Arthocare Corporation | 2012-12-11 | 271 | 0 |
| K123268 | SMARTSTITCH PERFECTPASSER SYSTEM | Arthocare Corporation | 2012-11-07 | 19 | 0 |
| K121306 | SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HAND | Arthocare Corporation | 2012-07-12 | 72 | 0 |
| K013334 | ENDOFLIP | Arthocare Corporation | 2001-12-13 | 65 | 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