Arthrex, Inc.: FDA clearances and approvals
Arthrex, Inc. has 353 FDA 510(k) clearances (first 1992, latest 2026), across 41 product codes in 4 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 88 days, against 108 days for all cleared 510(k)s in the same product codes. openFDA lists 28 product recalls by a recalling firm named Arthrex, Inc. It is the industry lead sponsor of 7 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 7 | 50 |
| 2013 | 10 | 123 |
| 2014 | 12 | 52 |
| 2015 | 13 | 74 |
| 2016 | 11 | 131 |
| 2017 | 10 | 164 |
| 2018 | 16 | 109 |
| 2019 | 19 | 136 |
| 2020 | 26 | 68 |
| 2021 | 11 | 106 |
| 2022 | 17 | 90 |
| 2023 | 18 | 50 |
| 2024 | 10 | 90 |
| 2025 | 21 | 58 |
| 2026 | 15 | 105 |
Review time against the same product codes
Since 2017, Arthrex, Inc.'s cleared 510(k)s took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 52 | 52 |
| HWC | Screw, Fixation, Bone | 46 | 46 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 46 | 46 |
| HRS | Plate, Fixation, Bone | 39 | 39 |
| HRX | Arthroscope | 27 | 27 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 19 | 19 |
| HTN | Washer, Bolt Nut | 16 | 16 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 15 | 15 |
| HTY | Pin, Fixation, Smooth | 13 | 13 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 11 | 11 |
Plus 31 more product codes.
Review panels
- Orthopedic (314)
- General and Plastic Surgery (35)
- General Hospital (3)
- Radiology (1)
Most recent Arthrex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262451 | Arthrex DynaNite Staples | JDR | 2026-09-01 | 46 |
| K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | MAI | 2026-08-07 | 28 |
| K260624 | Arthrex Radial Head Replacement System | KWI | 2026-07-30 | 154 |
| K260018 | Arthrex FiberButton | MBI | 2026-06-26 | 172 |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw System | HWC | 2026-06-25 | 105 |
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | MAI | 2026-05-28 | 170 |
| K254215 | Arthrex Beaming System | HWC | 2026-05-08 | 130 |
| K260561 | Arthrex FiberTak Suture Anchor | MBI | 2026-03-20 | 29 |
| K252016 | Arthrex Humeral Nails | HSB | 2026-03-20 | 266 |
| K260405 | FiberTape Button | MBI | 2026-03-09 | 28 |
343 earlier clearances. See the full list in Caduvo.
Recalls
28 product recalls in 18 recall events; 2 initiated in the last five years. Most recent: 2022-11-02.
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.
Device clinical trials
Arthrex, Inc. is the industry lead sponsor of 7 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT05765266: ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial (Completed, started 2024-05-13)
- NCT05981833: Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears (Recruiting, started 2023-09-25)
- NCT05046600: Registry of Arthrex Hand and Wrist Products (Recruiting, started 2021-07-20)
- NCT04743895: Study Comparing Steel Wire to a Flat, Braided Suture to Close the Breastbone (Completed, started 2021-01-04)
- NCT04715139: Evaluate the Continued Safety and Performance of the Foot and Ankle Products (Recruiting, started 2020-12-01)
Frequently asked questions
How many FDA 510(k) clearances does Arthrex, Inc. have?
Arthrex, Inc. has 353 FDA 510(k) clearances (first 1992, latest 2026), across 41 product codes in 4 review panels.
How long does FDA take to clear Arthrex, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Arthrex, Inc.'s cleared 510(k)s is 90 days. Since 2017: 88 days, versus 108 days for all cleared 510(k)s in the same product codes.
What devices does Arthrex, Inc. make?
Its most frequent FDA product codes are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 52); HWC (Screw, Fixation, Bone, 46); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 46).
Has Arthrex, Inc. had device recalls?
openFDA lists 28 product recalls in 18 recall events by a recalling firm whose name matches Arthrex, Inc; the most recent began 2022-11-02. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 353 Arthrex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MBI, Arthrex, 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.