510(k) K203588 · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
ELEOS Limb Salvage System
| Applicant | Onkos Surgical, Parsippany NJ, US |
| Decision | Substantially Equivalent, Feb 5, 2021 |
| Received | Dec 8, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203588
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2025 | Onkos Surgical, Inc. ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants. Open, Classified |
JDI | None listed |
| Aug 25, 2025 | Onkos Surgical, Inc. ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants. Open, Classified |
JDI | None listed |
| Aug 25, 2025 | Onkos Surgical, Inc. ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants. Open, Classified |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.