Orthopaedic Implant Company: FDA clearances and approvals
Orthopaedic Implant Company has 10 FDA 510(k) clearances (first 2014, latest 2024), across 5 product codes in 1 review panel. Median 510(k) review time: 114 days. Since 2017 its median was 106 days, against 103 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 117 |
| 2015 | 1 | 118 |
| 2016 | 0 | — |
| 2017 | 1 | 155 |
| 2018 | 0 | — |
| 2019 | 1 | 101 |
| 2020 | 0 | — |
| 2021 | 2 | 120 |
| 2022 | 1 | 231 |
| 2023 | 2 | 85 |
| 2024 | 1 | 92 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Orthopaedic Implant Company's cleared 510(k)s took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 4 | 4 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| HTN | Washer, Bolt Nut | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Orthopaedic Implant Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233531 | OIC FLEX-FIX System | HTN | 2024-02-02 | 92 |
| K223761 | OIC Intramedullary Screw System | HWC | 2023-02-13 | 60 |
| K223118 | OIC Variable Angle Small Fragment Locking Plate System | HRS | 2023-01-21 | 110 |
| K212601 | DRPx Locking Distal Radius Plate System | HRS | 2022-04-05 | 231 |
| K202971 | DRPx Locking Distal Radius Plate System | HRS | 2021-05-06 | 218 |
| K211112 | OIC External Fixation System | KTT | 2021-05-05 | 21 |
| K183682 | OIC External Fixation System | KTT | 2019-04-08 | 101 |
| K171211 | OIC External Fixation System | KTT | 2017-09-27 | 155 |
| K150655 | OIC Intramedullary Nail System | HSB | 2015-07-09 | 118 |
| K140357 | OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM | HRS | 2014-06-09 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Orthopaedic Implant Company.
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 Orthopaedic Implant Company have?
Orthopaedic Implant Company has 10 FDA 510(k) clearances (first 2014, latest 2024), across 5 product codes in 1 review panel.
How long does FDA take to clear Orthopaedic Implant Company's 510(k)s?
The median time from FDA receipt to decision across Orthopaedic Implant Company's cleared 510(k)s is 114 days. Since 2017: 106 days, versus 103 days for all cleared 510(k)s in the same product codes.
What devices does Orthopaedic Implant Company make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 4); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 3); HSB (Rod, Fixation, Intramedullary And Accessories, 1).
Has Orthopaedic Implant Company had device recalls?
openFDA lists no recalls under a recalling firm name matching Orthopaedic Implant Company. Related entities may recall under other names.
Next steps
- See all 10 Orthopaedic Implant Company clearances with predicates and recalls
- Run predicate analysis for product code HRS, Orthopaedic Implant Company'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.