Xpert Ankle— 510(k) K261511

Name: FDA 510(k) clearance K261511
Creator: U.S. Food and Drug Administration
Published: 2026-07-28

Substantially Equivalent

Newclip Technics

FDA 510(k) clearance K261511 for Xpert Ankle, Substantially Equivalent on 2026-07-28. Applicant: Newclip Technics. Device class: 2.

Summary

Xpert Ankle from Newclip Technics is filed under HRS, bone fixation plates. The name points to the ankle, but the record doesn't list plate types or sizes.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).

Newclip Technics filed from Haute-Goulaine, France. Review took 82 calendar days (May 7 to July 28, 2026).

Clearance details

Applicant: Newclip Technics
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-05-07
Decision date: 2026-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haute-Goulaine, FR

Download summary PDF View on FDA.gov ↗

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K262649 — Alians Forearm2026-09-28
K261892 — ProRib Fixation System2026-09-23
K262098 — EnHAnce PEEK Bunion System2026-09-18
K262963 — TMC Implant Fixation System2026-09-15

More clearances from Newclip Technics

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K261191 — Alians Elbow S2026-07-08
K261038 — Xpert PFP2026-05-29
K253906 — Xpert Hand2026-03-11
K250767 — Newclip Patient-matched instrumentation non sterile PSI2025-10-01
K250155 — Xpert Knee2025-04-23

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.