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Sign in to claim this brandONKOS SURGICAL, INC.
US
Last updated September 17, 2026
What ONKOS SURGICAL, INC. makes
Onkos Surgical, Inc. manufactures orthopaedic fixation and reconstruction devices, including general internal fixation systems, femoral and tibial extension stems, knee femur stems, and bone screws. Their portfolio also covers reusable orthopaedic instruments, bone-resection reamers, and personalized pelvic reconstruction implants designed for limb salvage procedures.
The company’s devices are classified under FDA’s Class I, Class II, and Class III categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Onkos Surgical, Inc. manufacture?
Onkos Surgical, Inc. specializes in orthopaedic devices used for fixation and reconstruction. Their portfolio includes general internal orthopaedic fixation system implantation kits, femoral and tibial extension stems, knee femur stems, bone screws (both non-sliding and non-bioabsorbable), reusable orthopaedic instruments, bone-resection reamers, and personalized pelvic reconstruction implants. These devices are designed for procedures like limb salvage, where preserving limb function is critical.
Where is Onkos Surgical, Inc. based, and what does that mean for their regulatory oversight?
Onkos Surgical, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s risk-based system (Class I, II, or III) and potential listing in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track devices post-market for safety and performance monitoring.
Which regulatory registries or databases list Onkos Surgical, Inc.’s devices?
Onkos Surgical, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling transparent identification, tracking, and traceability throughout the supply chain and post-market surveillance. This helps healthcare providers and regulators verify device details like model, batch, and expiration.
How are Onkos Surgical, Inc.’s devices classified under FDA regulations?
Onkos Surgical, Inc.’s devices fall into FDA’s Class I, Class II, or Class III categories based on their risk level and intended use. Class I devices pose the lowest risk (e.g., some reusable instruments), Class II requires special controls to ensure safety and effectiveness (e.g., bone screws), and Class III includes higher-risk devices like certain orthopaedic prostheses that require pre-market approval due to substantial risk of illness or injury. Classification determines the regulatory pathway for authorization.
What distinguishes Onkos Surgical, Inc.’s orthopaedic devices from others in the market?
Onkos Surgical, Inc. focuses on advanced orthopaedic solutions, particularly for limb salvage and personalized reconstruction. Their portfolio includes reusable instruments and systems like the ELEOS™ Limb Salvage System and My3D® Personalized Pelvic Reconstruction, which are tailored to complex cases requiring precise bone alignment and fixation. These devices are designed to address high-risk procedures where traditional implants may fall short, emphasizing customization and durability.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 77 E HALSEY RD, Parsippany, NJ, 07054
- Website
- onkossurgical.com
- —
- —
- [email protected]
- Phone
- +1(844)767-2766
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3013450937
- DUNS Number
- 080254074
Catalogue (800)
Page 11 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Eleos™ | BT-16152-03N | FDA UDI | Class I | Active |
| Eleos™ | 2500R002E | FDA UDI | Class II | Active |
| Eleos™ | RT-17500-03N | FDA UDI | Class I | Active |
| ELEOS Limb Salvage System With BioGrip | HR-IMPAC-03N | FDA UDI | Class I | Active |
| ELEOS Limb Salvage System | HR-30000-03M | FDA UDI | Class II | Active |
| My3D® Personalized Pelvic Reconstruction | CS-65055-04M | FDA UDI | Class II | Active |
| Eleos™ | KPONTP41E | FDA UDI | Class II | Active |
| My3D® Personalized Pelvic Reconstruction | DG-LS100-04N | FDA UDI | Class II | Active |
| Eleos™ | 2500BP12E | FDA UDI | Class II | Active |
| My3D® Personalized Pelvic Reconstruction | TP-65050-04N | FDA UDI | Class II | Active |
| Eleos™ | SI-7501E-03N | FDA UDI | Class I | Active |
| Eleos™ | BT-18152-03N | FDA UDI | Class I | Active |
| Eleos™ | 25001050E | FDA UDI | Class II | Active |
| ELEOS™ Limb Salvage System | TB-2204E-01M | FDA UDI | Class II | Active |
| ELEOS Limb Salvage System | CB-17152-03M | FDA UDI | Class II | Active |
| Eleos™ | 25107400E | FDA UDI | Class I | Active |
| ELEOS Limb Salvage System | FB-11152-03M | FDA UDI | Class II | Active |
| Eleos™ | K0051022E | FDA UDI | Class I | Active |
| Eleos™ | 26012802E | FDA UDI | Class II | Active |
| Eleos™ | K0052003E | FDA UDI | Class I | Active |
| Eleos™ | 25107110E | FDA UDI | Class I | Active |
| My3D® Personalized Pelvic Reconstruction | LS-50030-04M | FDA UDI | Class II | Active |
| Eleos™ | 2500BP18E | FDA UDI | Class II | Active |
| Eleos™ | K0051012E | FDA UDI | Class I | Active |
| My3D® Personalized Pelvic Reconstruction | LS-50036-04M | FDA UDI | Class II | Active |
| Eleos™ | RT-ADAPT-03N | FDA UDI | Class I | Active |
| Eleos™ | 25107803E | FDA UDI | Class I | Active |
| Eleos™ | 25104009E | FDA UDI | Class I | Active |
| Eleos™ | 002-03-00010 | FDA UDI | Class I | Active |
| My3D® Personalized Pelvic Reconstruction | PV-ACREC-04M | FDA UDI | Class II | Active |
| ELEOS Limb Salvage System | FS-12120-03M | FDA UDI | Class II | Active |
| Eleos™ | KSP22100E | FDA UDI | Class II | Active |
| My3D® Personalized Pelvic Reconstruction | LS-50040-04M | FDA UDI | Class II | Active |
| Eleos™ | 25100061E | FDA UDI | Class I | Active |
| Eleos™ | K0053019E | FDA UDI | Class I | Active |
| Eleos™ | KSC01665E | FDA UDI | Class II | Active |
| Jts Extendible Distal Femoral Implant | imtprhp/Sm | FDA UDI | Class II | Active |
| Eleos™ | K0053041E | FDA UDI | Class I | Active |
| ELEOS™ Limb Salvage System | RF-L002E-01M | FDA UDI | Class II | Active |
| Jts Extendible Distal Femoral Implant | tckaxl/Std | FDA UDI | Class II | Active |
| My3D® Personalized Pelvic Reconstruction | PV-65TRY-04T | FDA UDI | Class II | Active |
| Eleos™ | SPSETB15E | FDA UDI | Class I | Active |
| ELEOS™ Limb Salvage System | RF-R002E-01M | FDA UDI | Class II | Active |
| Eleos™ | K0001006E | FDA UDI | Class I | Active |
| My3D® Personalized Pelvic Reconstruction | HD-35TRQ-04N | FDA UDI | Class II | Active |
| ELEOS Limb Salvage System | FS-19120-03M | FDA UDI | Class II | Active |
| Eleos™ | 25102305E | FDA UDI | Class I | Active |
| Eleos™ | KTAGB305E | FDA UDI | Class II | Active |
| Eleos™ | KSP16140E | FDA UDI | Class II | Active |
| Eleos™ | 002-03-00011 | FDA UDI | Class I | Active |
Related Companies
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FDA Recalls (16)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Onkos Surgical, Inc. has 16 recall records initiated between May 23, 2017, and July 11, 2025, with statuses recorded as open, classified, or terminated. The reasons cited include failures to perform required inspections before distribution, labeling errors such as incorrect collar sizes and mislabeled modular components, the presence of an unidentified substance on devices, potential seal breaches, and challenges with intraoperative assembly compatibility.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 11, 2025 | Z-2424-2025 | — | open, classified | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| Jul 11, 2025 | Z-2423-2025 | — | open, classified | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| Jul 11, 2025 | Z-2425-2025 | — | open, classified | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| May 20, 2025 | Z-2042-2025 | — | open, classified | Required inspections were not performed on finished product prior to release and distribution. |
| Sep 22, 2024 | Z-1857-2025 | — | open, classified | Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur. |
| Dec 22, 2023 | Z-1818-2025 | — | open, classified | 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. |
| Dec 22, 2023 | Z-1817-2025 | — | open, classified | 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. |
| Sep 1, 2023 | Z-1882-2025 | — | open, classified | Potential for breach of Tyvek seals. |
| Sep 1, 2023 | Z-1880-2025 | — | open, classified | Potential for breach of Tyvek seals. |
| Sep 1, 2023 | Z-1884-2025 | — | open, classified | Potential for breach of Tyvek seals. |
| Sep 1, 2023 | Z-1883-2025 | — | open, classified | Potential for breach of Tyvek seals. |
| Sep 1, 2023 | Z-1881-2025 | — | open, classified | Potential for breach of Tyvek seals. |
| Sep 1, 2023 | Z-1879-2025 | — | open, classified | Potential for breach of Tyvek seals. |
| May 23, 2017 | Z-2646-2017 | — | terminated | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm |
| May 23, 2017 | Z-2648-2017 | — | terminated | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm |
| May 23, 2017 | Z-2647-2017 | — | terminated | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm |