Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kfx Medical — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
91 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120841 | APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR | Kfx Medical | 2012-06-07 | 79 | 0 |
| K101175 | KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER | Kfx Medical | 2010-05-20 | 23 | 0 |
| K083609 | KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER | Kfx Medical | 2009-03-06 | 88 | 0 |
| K081598 | SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE ( | Kfx Medical | 2008-07-03 | 27 | 0 |
| K080229 | 5.5 MM SUTURE LOCK BONE SCREW ANCHOR | Kfx Medical | 2008-02-29 | 30 | 0 |
| K072063 | KFX TISSUE FIXATION SYSTEM AND ACCESSORIES | Kfx Medical | 2007-10-26 | 91 | 0 |
| K061294 | KFX KNOTLESS FIXATION SYSTEM | Kfx Medical | 2006-07-19 | 71 | 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