Onkos Surgical, Inc.
Parsippany, NJ, US
ONKOS SURGICAL, INC. appears in FDA device records in Parsippany, NJ. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Onkos Surgical, Inc. between 2016 and 2026. The busiest year on record is 2021, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253066 | ELEOS™ with NanoCept® Technology Limb Salvage System | QZZ | Substantially Equivalent | |
| K252920 | ELEOS™ Limb Salvage System with NanoCept® Technology | QZZ | Substantially Equivalent | |
| DEN210058 | ELEOSx™ Limb Salvage System | QZZ | Unknown | |
| K223348 | My3D® Personalized Pelvic Reconstruction | LPH | Substantially Equivalent | |
| K212815 | My3D® Personalized Pelvic Reconstruction | LPH | Substantially Equivalent | |
| K211677 | ELEOS Limb Salvage System | KRO | Substantially Equivalent | |
| K203815 | ELEOS Limb Salvage System with BioGrip | JDI | Substantially Equivalent | |
| K203588 | ELEOS™ Limb Salvage System | JDI | Substantially Equivalent | |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | JDI | Substantially Equivalent | |
| K180130 | ELEOS™ Bipolar Acetabular System | KWY | Substantially Equivalent | |
| K161520 | ELEOS Limb Salvage System | KRO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013450937 | 3013450937 | ONKOS SURGICAL, INC. | 77 E HALSEY RD, Parsippany, NJ 07054 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QZZLimb And Joint Salvage Device With Coating For Bacteria Reduction
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HWTTemplate
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2425-2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants. | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. | Class II | Open, Classified | |
| Z-2424-2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants. | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. | Class II | Open, Classified | |
| Z-2423-2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants. | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. | Class II | Open, Classified | |
| Z-2042-2025 | My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device | Required inspections were not performed on finished product prior to release and distribution. | Class II | Open, Classified | |
| Z-1857-2025 | ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System | Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur. | Class II | Open, Classified | |
| Z-1818-2025 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip. | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems. | Class II | Open, Classified | |
| Z-1817-2025 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip. | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems. | Class II | Open, Classified | |
| Z-1884-2025 | Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM | Potential for breach of Tyvek seals. | Class II | Open, Classified | |
| Z-1883-2025 | Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM | Potential for breach of Tyvek seals. | Class II | Open, Classified | |
| Z-1882-2025 | Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM | Potential for breach of Tyvek seals. | Class II | Open, Classified | |
| Z-1881-2025 | Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM | Potential for breach of Tyvek seals. | Class II | Open, Classified | |
| Z-1880-2025 | Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM | Potential for breach of Tyvek seals. | Class II | Open, Classified | |
| Z-1879-2025 | a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM | Potential for breach of Tyvek seals. | Class II | Open, Classified | |
| Z-2648-2017 | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm | Class II | Terminated | |
| Z-2647-2017 | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm | Class II | Terminated | |
| Z-2646-2017 | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain