Iconn Orthopedics, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Iconn Orthopedics, LLC” (first 2014, latest 2018), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 104 days. Since 2017 the median was 82 days, against 89 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 230 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 104 |
| 2018 | 3 | 59 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Iconn Orthopedics, LLC took a median 82 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 4 | 4 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Iconn Orthopedics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180670 | ICONN Campbell Interference Screw | HWC | 2018-12-07 | 268 |
| K182264 | ICONN Revolution Knotless Suture Anchor | MBI | 2018-10-19 | 59 |
| K181680 | ICONN Answer II Suture Anchor | MBI | 2018-08-09 | 44 |
| K172491 | ICONN Square 2.5MM Suture Anchor | MBI | 2017-11-29 | 104 |
| K132724 | ICONN ANSWER SUTURE ANCHOR | MBI | 2014-04-17 | 230 |
Recalls
openFDA lists no recalls under a recalling firm named Iconn Orthopedics, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Iconn Orthopedics, LLC?
FDA lists 5 510(k) clearances under the applicant name “Iconn Orthopedics, LLC” (first 2014, latest 2018), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Iconn Orthopedics, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Iconn Orthopedics, LLC is 104 days. Since 2017: 82 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Iconn Orthopedics, LLC?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 4); HWC (Screw, Fixation, Bone, 1).
Next steps
- See all 5 Iconn Orthopedics, LLC clearances with predicates and recalls
- Run predicate analysis for product code MBI, Iconn Orthopedics, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.