Onkos Surgical, Inc.
Medical device manufacturer in Parsippany, NJ.
10510(k) clearances
0PMA approvals
16recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253066 | ELEOS with NanoCept® Technology Limb Salvage SystemQZZ · Traditional | 06/08/2026SE |
| K252920 | ELEOS Limb Salvage System with NanoCept® TechnologyQZZ · Special | 10/15/2025SE |
| K223348 | My3D® Personalized Pelvic ReconstructionLPH · Traditional | 01/30/2023SE |
| K212815 | My3D® Personalized Pelvic ReconstructionLPH · Traditional | 07/06/2022SE |
| K211677 | ELEOS Limb Salvage SystemKRO · Traditional | 07/28/2021SE |
| K203815 | ELEOS Limb Salvage System with BioGripJDI · Traditional | 06/09/2021SE |
| K203588 | ELEOS Limb Salvage SystemJDI · Traditional | 02/05/2021SE |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIPJDI · Traditional | 12/11/2020SE |
| K180130 | ELEOS Bipolar Acetabular SystemKWY · Traditional | 02/23/2018SE |
| K161520 | ELEOS Limb Salvage SystemKRO · Traditional | 10/28/2016SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2425-2025 Class II | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED.…Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. | 07/11/2025Open, Classified |
| Z-2424-2025 Class II | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED…Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. | 07/11/2025Open, Classified |
| Z-2423-2025 Class II | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem…Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. | 07/11/2025Open, Classified |
| Z-2042-2025 Class II | My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component…Required inspections were not performed on finished product prior to release and distribution. | 05/20/2025Open, Classified |
| Z-1857-2025 Class II | ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb…Potential challenge with intraoperative assembly of the external taper of a single midsection with the… | 09/22/2024Open, Classified |
| Z-1818-2025 Class II | ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component…Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in… | 12/22/2023Open, Classified |
| Z-1817-2025 Class II | ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component…Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in… | 12/22/2023Open, Classified |
| Z-1884-2025 Class II | Male-Female Midsection with the following sizes and model numbers. a. Male-Female…Potential for breach of Tyvek seals. | 09/01/2023Open, Classified |
| Z-1883-2025 Class II | Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M…Potential for breach of Tyvek seals. | 09/01/2023Open, Classified |
| Z-1882-2025 Class II | Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M…Potential for breach of Tyvek seals. | 09/01/2023Open, Classified |
| Z-1881-2025 Class II | Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M…Potential for breach of Tyvek seals. | 09/01/2023Open, Classified |
| Z-1880-2025 Class II | Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M…Potential for breach of Tyvek seals. | 09/01/2023Open, Classified |
| Z-1879-2025 Class II | a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M…Potential for breach of Tyvek seals. | 09/01/2023Open, Classified |
| Z-2648-2017 Class II | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM…The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm | 05/23/2017Terminated |
| Z-2647-2017 Class II | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM…The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm | 05/23/2017Terminated |
| Z-2646-2017 Class II | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM…The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm | 05/23/2017Terminated |