Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bionx Implants, Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
169 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030388 | IMPACT SUTURE ANCHOR. MODEL 433510 | Bionx Implants, Ltd. | 2003-04-24 | 78 | 0 |
| K020056 | DUET SUTURE ANCHOR | Bionx Implants, Ltd. | 2002-06-26 | 169 | 0 |
| K012000 | 1.5MM BONE FIXATION KIT | Bionx Implants, Ltd. | 2001-07-18 | 21 | 0 |
| K012001 | SMARTSCREW | Bionx Implants, Ltd. | 2001-07-18 | 21 | 0 |
| K003077 | SMARTSCREW MODEL 222006...227510 | Bionx Implants, Ltd. | 2001-04-26 | 205 | 0 |
| K003757 | THERMOFX MESH | Bionx Implants, Ltd. | 2001-02-07 | 63 | 0 |
| K000616 | SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 43082 | Bionx Implants, Ltd. | 2000-03-23 | 28 | 0 |
| K993074 | SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531 | Bionx Implants, Ltd. | 1999-12-10 | 87 | 0 |
| K993073 | SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 23802 | Bionx Implants, Ltd. | 1999-12-06 | 83 | 0 |
| K993453 | MENISCUS ARROW, MODELS 531110, 531113, 531116 | Bionx Implants, Ltd. | 1999-11-09 | 27 | 0 |
| K992947 | CANNULATED SMARTSCREW MODELS 224540C, 224570C | Bionx Implants, Ltd. | 1999-09-21 | 20 | 0 |
| K992567 | ANATOMICAL BANKART TACK, MODEL 523520A | Bionx Implants, Ltd. | 1999-08-27 | 25 | 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