Arthocare Corporation: FDA clearances and approvals
Arthocare Corporation has 6 FDA 510(k) clearances (first 2001, latest 2016), across 3 product codes in 2 review panels. Median 510(k) review time: 68 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 72 |
| 2013 | 1 | 94 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 29 |
| 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 | 3 | 3 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Arthocare Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153669 | MultiFIX S Ultra Knotless Fixation System | MBI | 2016-01-19 | 29 |
| K131182 | MULTIFIX S KNOTLESS FIXATION DEVICE | MBI | 2013-07-29 | 94 |
| K120791 | AMBIENT TURBOFLASH 90 IFS | GEI | 2012-12-11 | 271 |
| K123268 | SMARTSTITCH PERFECTPASSER SYSTEM | GAT | 2012-11-07 | 19 |
| K121306 | SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE | GAT | 2012-07-12 | 72 |
| K013334 | ENDOFLIP | MBI | 2001-12-13 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Arthocare Corporation.
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 Arthocare Corporation have?
Arthocare Corporation has 6 FDA 510(k) clearances (first 2001, latest 2016), across 3 product codes in 2 review panels.
How long does FDA take to clear Arthocare Corporation's 510(k)s?
The median time from FDA receipt to decision across Arthocare Corporation's cleared 510(k)s is 68 days.
What devices does Arthocare Corporation make?
Its most frequent FDA product codes are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 3); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 2); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Has Arthocare Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Arthocare Corporation. Related entities may recall under other names.
Next steps
- See all 6 Arthocare Corporation clearances with predicates and recalls
- Run predicate analysis for product code MBI, Arthocare Corporation'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.