Kfx Medical: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Kfx Medical” (first 2006, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 71 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 | 79 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 7 | 7 |
Review panels
- Orthopedic (7)
Most recent Kfx Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120841 | APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR | MBI | 2012-06-07 | 79 |
| K101175 | KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER | MBI | 2010-05-20 | 23 |
| K083609 | KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE | MBI | 2009-03-06 | 88 |
| K081598 | SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE | MBI | 2008-07-03 | 27 |
| K080229 | 5.5 MM SUTURE LOCK BONE SCREW ANCHOR | MBI | 2008-02-29 | 30 |
| K072063 | KFX TISSUE FIXATION SYSTEM AND ACCESSORIES | MBI | 2007-10-26 | 91 |
| K061294 | KFX KNOTLESS FIXATION SYSTEM | MBI | 2006-07-19 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Kfx Medical.
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 Kfx Medical?
FDA lists 7 510(k) clearances under the applicant name “Kfx Medical” (first 2006, latest 2012), across 1 product code 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 Kfx Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kfx Medical is 71 days.
Which FDA product codes appear under Kfx Medical?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 7).
Next steps
- See all 7 Kfx Medical clearances with predicates and recalls
- Run predicate analysis for product code MBI, Kfx Medical'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.