The Orthopaedic Implant Company: FDA clearances and approvals
The Orthopaedic Implant Company has 5 FDA 510(k) clearances (first 2012, latest 2024), across 5 product codes in 1 review panel. Median 510(k) review time: 85 days. Since 2017 its median was 85 days, against 94 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 83 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 313 |
| 2017 | 0 | — |
| 2018 | 2 | 88 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 27 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, The Orthopaedic Implant Company's cleared 510(k)s took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent The Orthopaedic Implant Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242995 | OIC Small / Mini Fragment Plate System | HRS | 2024-10-23 | 27 |
| K182736 | OIC Suture Anchor System | MBI | 2018-12-28 | 91 |
| K181184 | OIC Intramedullary Nail System | HSB | 2018-07-27 | 85 |
| K160222 | OIC Cervical PEEK Spacer | ODP | 2016-12-07 | 313 |
| K113123 | OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM | KTT | 2012-01-12 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named The 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 The Orthopaedic Implant Company have?
The Orthopaedic Implant Company has 5 FDA 510(k) clearances (first 2012, latest 2024), across 5 product codes in 1 review panel.
How long does FDA take to clear The Orthopaedic Implant Company's 510(k)s?
The median time from FDA receipt to decision across The Orthopaedic Implant Company's cleared 510(k)s is 85 days. Since 2017: 85 days, versus 94 days for all cleared 510(k)s in the same product codes.
What devices does The Orthopaedic Implant Company make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 1); HSB (Rod, Fixation, Intramedullary And Accessories, 1); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 1).
Has The Orthopaedic Implant Company had device recalls?
openFDA lists no recalls under a recalling firm name matching The Orthopaedic Implant Company. Related entities may recall under other names.
Next steps
- See all 5 The Orthopaedic Implant Company clearances with predicates and recalls
- Run predicate analysis for product code HRS, The 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.