Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bonutti Research, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
230 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161628 | JAS Pulse(TM) Ultrasonic Therapy | Bonutti Research, Inc. | 2016-11-10 | 150 | 0 |
| K093078 | UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS | Bonutti Research, Inc. | 2010-06-23 | 266 | 0 |
| K090175 | UNITY BETA PLLA SYSTEM | Bonutti Research, Inc. | 2009-09-10 | 230 | 0 |
| K082906 | UNITY BETA ANCHOR SYSTEM | Bonutti Research, Inc. | 2008-10-30 | 30 | 0 |
| K062820 | UNITY ALPHA SYSTEM | Bonutti Research, Inc. | 2007-03-15 | 176 | 0 |
| K060283 | TRANSET SYSTEM | Bonutti Research, Inc. | 2006-02-22 | 19 | 0 |
| K052799 | MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM | Bonutti Research, Inc. | 2005-12-16 | 74 | 0 |
| K033717 | TRANSET FRACTURE FIXATION SYSTEM | Bonutti Research, Inc. | 2004-02-25 | 91 | 0 |
| K013177 | MULTITAK SUTURE SNAP SYSTEM | Bonutti Research, Inc. | 2001-12-19 | 86 | 0 |
| K012465 | MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR | Bonutti Research, Inc. | 2001-10-29 | 89 | 0 |
| K010479 | MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR | Bonutti Research, Inc. | 2001-05-08 | 77 | 0 |
| K993115 | MULTITAK SS | Bonutti Research, Inc. | 1999-12-17 | 88 | 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