510(k) K161520 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
ELEOS Limb Salvage System
| Applicant | Onkos Surgical, Inc., Parsippany NJ, US |
| Decision | Substantially Equivalent, Oct 28, 2016 |
| Received | Jun 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161520
| 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 |
| May 29, 2025 | Onkos Surgical, Inc. 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-15 Open, Classified |
KRO | None listed |
| May 29, 2025 | Onkos Surgical, Inc. 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- Open, Classified |
KRO | None listed |
| May 29, 2025 | Onkos Surgical, Inc. 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-2015 Open, Classified |
KRO | None listed |
| May 29, 2025 | Onkos Surgical, Inc. 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
Open, Classified |
KRO | None listed |
| May 28, 2025 | Onkos Surgical, Inc. ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E.
Component of ELEOS Limb Salvage System Open, Classified |
KRO | None listed |
| May 23, 2017 | Onkos Surgical, Inc. ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E Terminated |
KRO | None listed |
| May 23, 2017 | Onkos Surgical, Inc. ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E Terminated |
KRO | None listed |
| May 23, 2017 | Onkos Surgical, Inc. ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.