Arthrex DynaNite Staples— 510(k) K262451
Substantially EquivalentArthrex, Inc.
FDA 510(k) clearance K262451 for Arthrex DynaNite Staples, Substantially Equivalent on 2026-09-01. Applicant: Arthrex, Inc.. Device class: 2.
Summary
Arthrex DynaNite Staples are from Arthrex, Inc., filed under product code JDR (Staple, Fixation, Bone). The record gives no sizes or configurations.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Arthrex filed from Naples, Florida. The decision came 46 calendar days after FDA received it (July 17 to September 1, 2026).
Clearance details
- Applicant
- Arthrex, Inc.
- Product code
- Product code JDR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Naples, FL, US
Recent devices under product code JDR
view allMore clearances from Arthrex, Inc.
view allAdverse events under product code JDR
product code JDR- Injury
- 726
- Malfunction
- 663
- Other
- 1
- Total
- 1,390
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.