Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Small Bone Innovations, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
179 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130147 | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKIN | Small Bone Innovations, Inc. | 2013-05-03 | 101 | 0 |
| K112982 | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING | Small Bone Innovations, Inc. | 2012-04-02 | 179 | 0 |
| K102180 | RHEAD RADIAL HEAD EXTENDED STEMS | Small Bone Innovations, Inc. | 2010-12-20 | 140 | 2 |
| K092754 | SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 | Small Bone Innovations, Inc. | 2010-01-19 | 132 | 0 |
| K093550 | MINI RAIL EXTERNAL FIXATOR SYSTEM | Small Bone Innovations, Inc. | 2010-01-07 | 51 | 0 |
| K073635 | SBI SR MTP TOE IMPLANT | Small Bone Innovations, Inc. | 2008-03-19 | 84 | 0 |
| K071541 | SBI TWISTOFIX | Small Bone Innovations, Inc. | 2007-09-10 | 97 | 0 |
| K063635 | SBI FOREFOOT SET | Small Bone Innovations, Inc. | 2007-08-29 | 266 | 0 |
| K071656 | SBI ARTFIX | Small Bone Innovations, Inc. | 2007-08-27 | 90 | 0 |
| K071540 | SBI TITANIUM THREADED PIN | Small Bone Innovations, Inc. | 2007-08-08 | 64 | 0 |
| K071549 | SBI RHEAD PLATING SYSTEM | Small Bone Innovations, Inc. | 2007-08-07 | 62 | 0 |
| K071479 | SBI STAFIX | Small Bone Innovations, Inc. | 2007-08-02 | 65 | 0 |
| K071394 | MODIFICATION TO:SBI RINGFIX | Small Bone Innovations, Inc. | 2007-06-29 | 39 | 1 |
| K070793 | SBI DISTAL RADIUS VOLAR PLATING SYSTEM | Small Bone Innovations, Inc. | 2007-05-30 | 69 | 0 |
| K070236 | SBI LATERAL RADIO CAPITELLUM | Small Bone Innovations, Inc. | 2007-02-21 | 27 | 2 |
| K062898 | SBI LATERAL RHEAD IMPLANT | Small Bone Innovations, Inc. | 2006-11-13 | 47 | 1 |
| K062903 | SBI CARPAL FUSION PLATE | Small Bone Innovations, Inc. | 2006-10-20 | 23 | 0 |
| K062040 | SBI TRIHEDRON MTP HEMI GT | Small Bone Innovations, Inc. | 2006-10-03 | 76 | 0 |
| K061146 | SBI ULNAR HEAD IMPLANT | Small Bone Innovations, Inc. | 2006-07-19 | 85 | 2 |
| K060038 | SBI RADIO-CAPITELLAR IMPLANT | Small Bone Innovations, Inc. | 2006-03-30 | 83 | 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