510(k) K203815 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
ELEOS Limb Salvage System with BioGrip
| Applicant | Onkos Surgical, Parsippany NJ, US |
| Decision | Substantially Equivalent, Jun 9, 2021 |
| Received | Dec 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203815
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2025 | Onkos Surgical, Inc. 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 Open, Classified |
JDI | None listed |
| May 23, 2025 | Onkos Surgical, Inc. ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M.
Component of Limb Salvage System with BioGrip. Open, Classified |
JDI | None listed |
| May 23, 2025 | Onkos Surgical, Inc. ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M.
Component of Limb Salvage System with BioGrip. Open, Classified |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.