Orthopro, LLC: FDA clearances and approvals
Orthopro, LLC has 7 FDA 510(k) clearances (first 2006, latest 2013), across 4 product codes in 1 review panel. Median 510(k) review time: 136 days. openFDA lists 1 product recall by a recalling firm named Orthopro, LLC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 231 |
| 2013 | 1 | 157 |
| 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 | 2 | 2 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Orthopro, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122936 | ANKLE TRAUMA SYSTEM | HRS | 2013-02-28 | 157 |
| K113006 | I-FUSE HAMMER TOE SYSTEMS | HWC | 2012-05-25 | 231 |
| K093055 | CSTS SCREW | HWC | 2010-11-22 | 418 |
| K073228 | DC ULNAR SHORTENING SYSTEM | HRS | 2008-02-29 | 106 |
| K070555 | ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES | HTY | 2007-07-13 | 136 |
| K071243 | METAL HEMI IMPLANT | KWD | 2007-05-23 | 20 |
| K062908 | ORTHROPRO HEMI TOE | KWD | 2006-11-13 | 47 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-05-29.
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 Orthopro, LLC have?
Orthopro, LLC has 7 FDA 510(k) clearances (first 2006, latest 2013), across 4 product codes in 1 review panel.
How long does FDA take to clear Orthopro, LLC's 510(k)s?
The median time from FDA receipt to decision across Orthopro, LLC's cleared 510(k)s is 136 days.
What devices does Orthopro, LLC make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 2); HWC (Screw, Fixation, Bone, 2); KWD (Prosthesis, Toe, Hemi-, Phalangeal, 2).
Has Orthopro, LLC had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Orthopro, LLC; the most recent began 2008-05-29. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Orthopro, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, Orthopro, LLC'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.