Bonutti Research, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Bonutti Research, Inc.” (first 1997, latest 2016), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 86 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 | 1 | 150 |
| 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 5 | 5 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| HTY | Pin, Fixation, Smooth | 3 | 3 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 3 | 3 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
Review panels
Most recent Bonutti Research, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161628 | JAS Pulse(TM) Ultrasonic Therapy | IMI | 2016-11-10 | 150 |
| K093078 | UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS | HWC | 2010-06-23 | 266 |
| K090175 | UNITY BETA PLLA SYSTEM | HWC | 2009-09-10 | 230 |
| K082906 | UNITY BETA ANCHOR SYSTEM | HWC | 2008-10-30 | 30 |
| K062820 | UNITY ALPHA SYSTEM | HWC | 2007-03-15 | 176 |
| K060283 | TRANSET SYSTEM | HTY | 2006-02-22 | 19 |
| K052799 | MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM | MAI | 2005-12-16 | 74 |
| K033717 | TRANSET FRACTURE FIXATION SYSTEM | HTY | 2004-02-25 | 91 |
| K013177 | MULTITAK SUTURE SNAP SYSTEM | GAM | 2001-12-19 | 86 |
| K012465 | MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR | MAI | 2001-10-29 | 89 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bonutti Research, 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 Bonutti Research, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Bonutti Research, Inc.” (first 1997, latest 2016), across 6 product codes in 3 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 Bonutti Research, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bonutti Research, Inc. is 86 days.
Which FDA product codes appear under Bonutti Research, Inc.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 5); HWC (Screw, Fixation, Bone, 4); HTY (Pin, Fixation, Smooth, 3).
Next steps
- See all 17 Bonutti Research, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MBI, Bonutti Research, 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.