Onkos Surgical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
10
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2423-2025Class IIELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.July 11, 2025
Z-2425-2025Class IIELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal fillingJuly 11, 2025
Z-2424-2025Class IIELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3July 11, 2025
Z-2042-2025Class IIMy3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a CuMay 20, 2025
Z-1857-2025Class IIELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage SystemSeptember 22, 2024
Z-1818-2025Class IIELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of LimbDecember 22, 2023
Z-1817-2025Class IIELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of LimbDecember 22, 2023
Z-1884-2025Class IIMale-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mSeptember 1, 2023
Z-1881-2025Class IISegmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FSeptember 1, 2023
Z-1880-2025Class IISegmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-September 1, 2023
Z-1882-2025Class IISegmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13September 1, 2023
Z-1879-2025Class IIa. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. September 1, 2023
Z-1883-2025Class IIEthos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11September 1, 2023
Z-2647-2017Class IIELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHTMay 23, 2017
Z-2646-2017Class IIELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHTMay 23, 2017
Z-2648-2017Class IIELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHTMay 23, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K252920ELEOS™ Limb Salvage System with NanoCept® TechnologyOctober 15, 2025
DEN210058ELEOSx™ Limb Salvage SystemApril 5, 2024
K223348My3D® Personalized Pelvic ReconstructionJanuary 30, 2023
K212815My3D® Personalized Pelvic ReconstructionJuly 6, 2022
K211677ELEOS Limb Salvage SystemJuly 28, 2021
K203815ELEOS Limb Salvage System with BioGripJune 9, 2021
K203588ELEOS™ Limb Salvage SystemFebruary 5, 2021
K203090ELEOS Limb Salvage System featuring BIOGRIPDecember 11, 2020
K180130ELEOS™ Bipolar Acetabular SystemFebruary 23, 2018
K161520ELEOS Limb Salvage SystemOctober 28, 2016