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.

Clearance details

Applicant: Newclip Technics
Product code: 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 ↗

Recent devices under product code HRS

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K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261406 — Versalock Proximal Tibial Plating System2026-07-21
K262032 — TriMed Non-Spanning Wrist Fusion Plates (4 models)2026-07-16

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.