Arthrex
Medical device makerAI in United StatesAI. FDA records under 2 spellings of its name, each linked to the record.
- Records across the group: 387, 2 entitiesAI
- 510(k) clearances: 359
- Device recalls: 28
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Arthrex and its 1 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Oct 29, 2026 | Arthrex Plates, Screws and Pins, and WashersK263602 · HRS | 510(k) clearances |
| Oct 27, 2026 | Arthrex FiberButtonK263477 · MBI | 510(k) clearances |
| Sep 25, 2026 | Arthrex Beaming SystemK262975 · HWC | 510(k) clearances |
| Sep 24, 2026 | Arthrex Spine Compression FT ScrewK262618 · MRW | 510(k) clearances |
| Sep 1, 2026 | Arthrex DynaNite StaplesK262451 · JDR | 510(k) clearances |
| Aug 7, 2026 | Arthrex Bioabsorbable PushLock Suture AnchorsK262357 · MAI | 510(k) clearances |
| Jul 30, 2026 | Arthrex Radial Head Replacement SystemK260624 · KWI | 510(k) clearances |
| Jun 26, 2026 | Arthrex FiberButtonK260018 · MBI | 510(k) clearances |
| Nov 2, 2022 | Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.Class II · The devices may be packaged with the wrong reamer size. | Device recalls |
| Mar 25, 2022 | K-Wire, 1.35 mm x 170 mmClass II · Products do not meet length and diameter specifications. | Device recalls |
| Jun 14, 2021 | Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCCClass II · Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch. | Device recalls |
| Mar 11, 2021 | Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proxClass II · It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. | Device recalls |
| Feb 24, 2021 | Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.Class II · The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color. | Device recalls |
| Jun 24, 2020 | Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone scClass II · Screws provided in packaging are 5mm shorter than intended | Device recalls |
| Dec 17, 2019 | Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting GuideClass II · There is a potential for blockage of the Hub Attachment Tube. | Device recalls |
| Oct 1, 2019 | Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is inteClass II · Screws provided in the device package are 6 mm longer than intended. | Device recalls |
Subsidiaries and Divisions
1 firms in the Arthrex group, most records first- Arthrex Arthroscopy Instruments2 records
Canada and Imports
Across the Arthrex group, matched by company name- Active Health Canada device licences
- 178, as of Nov 10, 2026
Names and Identifiers
- Appears as
- Website
- arthrex.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built