Ortho Solutions Limited: FDA clearances and approvals
Ortho Solutions Limited has 6 FDA 510(k) clearances (first 2011, latest 2014), across 4 product codes in 1 review panel. Median 510(k) review time: 116 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 113 |
| 2013 | 0 | — |
| 2014 | 1 | 21 |
| 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 | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Ortho Solutions Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141784 | ORTHO SOLUTIONS ULTOS PLATING SYSTEM | HRS | 2014-07-23 | 21 |
| K121575 | OXFORD ANKLE FUSION NAIL(AFN) SYSTEM | HSB | 2012-09-14 | 107 |
| K120360 | ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS | HRS | 2012-05-29 | 113 |
| K111678 | ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS | HRS | 2012-02-07 | 237 |
| K110895 | ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS | HWC | 2011-12-19 | 264 |
| K102743 | ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES | HWE | 2011-01-20 | 120 |
Recalls
openFDA lists no recalls under a recalling firm named Ortho Solutions Limited.
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 Ortho Solutions Limited have?
Ortho Solutions Limited has 6 FDA 510(k) clearances (first 2011, latest 2014), across 4 product codes in 1 review panel.
How long does FDA take to clear Ortho Solutions Limited's 510(k)s?
The median time from FDA receipt to decision across Ortho Solutions Limited's cleared 510(k)s is 116 days.
What devices does Ortho Solutions Limited make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 3); HSB (Rod, Fixation, Intramedullary And Accessories, 1); HWC (Screw, Fixation, Bone, 1).
Has Ortho Solutions Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Ortho Solutions Limited. Related entities may recall under other names.
Next steps
- See all 6 Ortho Solutions Limited clearances with predicates and recalls
- Run predicate analysis for product code HRS, Ortho Solutions Limited'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.