Small Bone Innovations, Inc.: FDA clearances and approvals
Small Bone Innovations, Inc. has 24 FDA 510(k) clearances (first 2005, latest 2013), across 11 product codes in 1 review panel. Median 510(k) review time: 69 days. openFDA lists 3 product recalls by a recalling firm named Small Bone Innovations, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 179 |
| 2013 | 1 | 101 |
| 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 5 | 5 |
| HWC | Screw, Fixation, Bone | 5 | 5 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 2 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (24)
Most recent Small Bone Innovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130147 | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL) | HSB | 2013-05-03 | 101 |
| K112982 | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) | HSB | 2012-04-02 | 179 |
| K102180 | RHEAD RADIAL HEAD EXTENDED STEMS | JDB | 2010-12-20 | 140 |
| K092754 | SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 | HWC | 2010-01-19 | 132 |
| K093550 | MINI RAIL EXTERNAL FIXATOR SYSTEM | KTT | 2010-01-07 | 51 |
| K073635 | SBI SR MTP TOE IMPLANT | KWD | 2008-03-19 | 84 |
| K071541 | SBI TWISTOFIX | HWC | 2007-09-10 | 97 |
| K063635 | SBI FOREFOOT SET | HWC | 2007-08-29 | 266 |
| K071656 | SBI ARTFIX | HWC | 2007-08-27 | 90 |
| K071540 | SBI TITANIUM THREADED PIN | JDW | 2007-08-08 | 64 |
14 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2014-05-19.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Small Bone Innovations, Inc. have?
Small Bone Innovations, Inc. has 24 FDA 510(k) clearances (first 2005, latest 2013), across 11 product codes in 1 review panel.
How long does FDA take to clear Small Bone Innovations, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Small Bone Innovations, Inc.'s cleared 510(k)s is 69 days.
What devices does Small Bone Innovations, Inc. make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 5); HWC (Screw, Fixation, Bone, 5); JDB (Prosthesis, Elbow, Semi-Constrained, Cemented, 3).
Has Small Bone Innovations, Inc. had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches Small Bone Innovations, Inc; the most recent began 2014-05-19. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 24 Small Bone Innovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Small Bone Innovations, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.