Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Bionx Implants, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
263 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023022 | NUGEN FX SCREW | Bionx Implants, Inc. | 2002-10-04 | 23 | 0 |
| K011569 | BIOSORBFX O/M 2.0/2/4 SYSTEM | Bionx Implants, Inc. | 2002-02-22 | 277 | 0 |
| K013546 | MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6 | Bionx Implants, Inc. | 2001-11-21 | 28 | 0 |
| K013057 | BIOCUFF,C, MODELS 236018, 236028, 236036 | Bionx Implants, Inc. | 2001-10-12 | 30 | 0 |
| K012334 | CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 | Bionx Implants, Inc. | 2001-09-19 | 57 | 0 |
| K010983 | PLLA PIN | Bionx Implants, Inc. | 2001-06-13 | 72 | 0 |
| K010554 | MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA20 | Bionx Implants, Inc. | 2001-05-25 | 88 | 0 |
| K010687 | BIOSORBFX AND BIOSORBPDX MESH | Bionx Implants, Inc. | 2001-03-14 | 6 | 0 |
| K003659 | PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,17 | Bionx Implants, Inc. | 2001-02-20 | 84 | 0 |
| K003970 | CONTOUR LABRAL NAIL, MODEL 533520A | Bionx Implants, Inc. | 2001-01-12 | 21 | 0 |
| K003756 | BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FA | Bionx Implants, Inc. | 2001-01-03 | 28 | 0 |
| K001378 | BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 2357 | Bionx Implants, Inc. | 2000-07-28 | 88 | 0 |
| K000836 | BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM | Bionx Implants, Inc. | 2000-06-08 | 86 | 0 |
| K982721 | BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTE | Bionx Implants, Inc. | 1999-02-17 | 197 | 0 |
| K982139 | BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM | Bionx Implants, Inc. | 1998-09-15 | 90 | 0 |
| K972783 | BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR | Bionx Implants, Inc. | 1998-04-14 | 263 | 0 |
| K972919 | BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED | Bionx Implants, Inc. | 1998-03-27 | 232 | 0 |
| K974876 | BIONX DISTAL RADIUS SCREW | Bionx Implants, Inc. | 1998-03-20 | 81 | 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