ELEOS Limb Salvage System— 510(k) K211677

Name: FDA 510(k) clearance K211677
Creator: U.S. Food and Drug Administration
Published: 2021-07-28

Substantially Equivalent

Onkos Surgical

FDA 510(k) clearance K211677 for ELEOS Limb Salvage System, Substantially Equivalent on 2021-07-28. Applicant: Onkos Surgical. Device class: 2.

Clearance details

Applicant: Onkos Surgical
Product code: Code KRO
Device class: Class 2
Regulation: 21 CFR 888.3510
Advisory panel: Orthopedic
Date received: 2021-06-01
Decision date: 2021-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRO

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K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System2026-08-06
K252898 — Triathlon® Tritanium® Asymmetric Patella +5 more2025-12-15
K252303 — Stem Extension Line (USTAR II System)2025-08-22
K251665 — Triathlon® Hinge Knee System2025-07-25
K242871 — ATTUNE Revision Hinge Knee2024-11-21

More clearances from Onkos Surgical

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DEN210058 — ELEOSx Limb Salvage System2024-04-05
K212815 — My3D® Personalized Pelvic Reconstruction2022-07-06
K203815 — ELEOS Limb Salvage System with BioGrip2021-06-09
K203588 — ELEOS Limb Salvage System2021-02-05
K203090 — ELEOS Limb Salvage System featuring BIOGRIP2020-12-11

Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.