Bionx Implants, Inc.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Bionx Implants, Inc.” (first 1998, latest 2003), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 75 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 11 | 11 |
| HWC | Screw, Fixation, Bone | 10 | 10 |
| JEY | Plate, Bone | 7 | 7 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
Review panels
- Orthopedic (23)
- Dental (7)
Most recent Bionx Implants, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030388 | IMPACT SUTURE ANCHOR. MODEL 433510 | HWC | 2003-04-24 | 78 |
| K023022 | NUGEN FX SCREW | HWC | 2002-10-04 | 23 |
| K020056 | DUET SUTURE ANCHOR | HWC | 2002-06-26 | 169 |
| K011569 | BIOSORBFX O/M 2.0/2/4 SYSTEM | JEY | 2002-02-22 | 277 |
| K013546 | MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 | HWC | 2001-11-21 | 28 |
| K013057 | BIOCUFF,C, MODELS 236018, 236028, 236036 | MAI | 2001-10-12 | 30 |
| K012334 | CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 | MAI | 2001-09-19 | 57 |
| K012001 | SMARTSCREW | HWC | 2001-07-18 | 21 |
| K012000 | 1.5MM BONE FIXATION KIT | HWC | 2001-07-18 | 21 |
| K010983 | PLLA PIN | HTY | 2001-06-13 | 72 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bionx Implants, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bionx Implants, Inc.?
FDA lists 30 510(k) clearances under the applicant name “Bionx Implants, Inc.” (first 1998, latest 2003), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bionx Implants, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bionx Implants, Inc. is 75 days.
Which FDA product codes appear under Bionx Implants, Inc.?
The most frequent FDA product codes under this applicant name are MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 11); HWC (Screw, Fixation, Bone, 10); JEY (Plate, Bone, 7).
Next steps
- See all 30 Bionx Implants, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAI, Bionx Implants, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.