Arthrotek, Inc.: FDA clearances and approvals
Arthrotek, Inc. has 17 FDA 510(k) clearances (first 1987, latest 2006), across 7 product codes in 3 review panels. Median 510(k) review time: 78 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 4 | 4 |
| JDR | Staple, Fixation, Bone | 4 | 4 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 4 | 4 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| NFQ | Device, Dental Sonography, For Monitoring Jaw Sounds | 1 | 1 |
Review panels
- Orthopedic (14)
- General and Plastic Surgery (2)
- Dental (1)
Most recent Arthrotek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061776 | ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE | JDR | 2006-09-25 | 94 |
| K061801 | 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS | JDR | 2006-08-07 | 42 |
| K061657 | HITCH LACTOSORB SUTURE ANCHOR | JDR | 2006-07-25 | 42 |
| K061389 | ALLTHREAD LACTOSORB SUTURE ANCHOR | JDR | 2006-07-19 | 62 |
| K060693 | MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR | HWC | 2006-06-06 | 83 |
| K053461 | EZLOC FEMORAL FIXATION DEVICE | MBI | 2006-02-03 | 52 |
| K051069 | NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER | MBI | 2005-06-29 | 64 |
| K042460 | TI - SCREW ANCHOR SP | MBI | 2004-10-29 | 49 |
| K041274 | RESORBABLE INTERFERENCE SCREW | HWC | 2004-07-28 | 77 |
| K041261 | FEMORAL HOOK | MBI | 2004-06-07 | 27 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Arthrotek, Inc..
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 Arthrotek, Inc. have?
Arthrotek, Inc. has 17 FDA 510(k) clearances (first 1987, latest 2006), across 7 product codes in 3 review panels.
How long does FDA take to clear Arthrotek, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Arthrotek, Inc.'s cleared 510(k)s is 78 days.
What devices does Arthrotek, Inc. make?
Its most frequent FDA product codes are HWC (Screw, Fixation, Bone, 4); JDR (Staple, Fixation, Bone, 4); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 4).
Has Arthrotek, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Arthrotek, Inc. Related entities may recall under other names.
Next steps
- See all 17 Arthrotek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Arthrotek, Inc.'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.