D.N.E. External Fixation System— 510(k) K151580

Name: FDA 510(k) clearance K151580
Creator: U.S. Food and Drug Administration
Published: 2016-02-16

Substantially Equivalent

Dne, LLC

FDA 510(k) clearance K151580 for D.N.E. External Fixation System, Substantially Equivalent on 2016-02-16. Applicant: Dne, LLC. Device class: 2.

Clearance details

Applicant: Dne, LLC
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2015-06-11
Decision date: 2016-02-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Slatington, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTT

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K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System2026-06-11
K260900 — DYNEX® External Fixation Systems2026-04-17
K260112 — QuikFix External Fixator: Knee-Spanning Pack2026-03-23
K253291 — Excelsior System2026-01-20
K253202 — Hoffmann LRF System2025-12-19

More clearances from Dne, LLC

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K140158 — S.E.A.L. FRACTURE FUSION TUBE2014-05-29
K113106 — DNE EXTERNAL FIXATION SYSTEM2012-01-04

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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 →

Recalls naming K151580

K-number listed on FDA's recall record

Z-2513-2025 — Medshape Universal Joints, REF: DNE-9000-UJClass II·Ongoing·Medshape, INC.·20250602

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151580.

Data sourced from openFDA. This site is unofficial and independent of the FDA.