Iconacy Orthopedic Implants, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Iconacy Orthopedic Implants, LLC” (first 2012, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 124 days. 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 |
|---|---|---|
| 2012 | 1 | 152 |
| 2013 | 1 | 95 |
| 2014 | 2 | 156 |
| 2015 | 0 | — |
| 2016 | 2 | 175 |
| 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 5 | 5 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Iconacy Orthopedic Implants, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160266 | ICONACY(TM) I-Hip(TM) | LPH | 2016-04-08 | 66 |
| K151307 | ICONACY(TM) I-Hip (TM) | LZO | 2016-02-26 | 284 |
| K132572 | I-HIP TOTAL HIP SYSTEM | LPH | 2014-03-28 | 225 |
| K133228 | ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM | LPH | 2014-01-17 | 88 |
| K131279 | ICONACY I-HIP SYSTEM | LPH | 2013-08-09 | 95 |
| K121034 | IOI TOTAL HIP | LPH | 2012-09-04 | 152 |
Recalls
openFDA lists no recalls under a recalling firm named Iconacy Orthopedic Implants, 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 Iconacy Orthopedic Implants, LLC?
FDA lists 6 510(k) clearances under the applicant name “Iconacy Orthopedic Implants, LLC” (first 2012, latest 2016), 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 Iconacy Orthopedic Implants, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Iconacy Orthopedic Implants, LLC is 124 days.
Which FDA product codes appear under Iconacy Orthopedic Implants, LLC?
The most frequent FDA product codes under this applicant name are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 5); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 1).
Next steps
- See all 6 Iconacy Orthopedic Implants, LLC clearances with predicates and recalls
- Run predicate analysis for product code LPH, Iconacy Orthopedic Implants, 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.