Company · US
Onkos Surgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (2 in 12 months)
18recalls (2 in 12 months)
16recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 11 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 9 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 4 |
| QZZ | Limb And Joint Salvage Device With Coating For Bacteria Reduction | 4 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| QHQ | Total Shoulder Arthroplasty System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2026 | K263628 | ELEOS Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C) Onkos Surgical, Inc. | QZZ |
| Jun 8, 2026 | K253066 | ELEOS with NanoCept® Technology Limb Salvage System Onkos Surgical, Inc. | QZZ |
| Oct 15, 2025 | K252920 | ELEOS Limb Salvage System with NanoCept® Technology Onkos Surgical, Inc. | QZZ |
| Apr 5, 2024 | DEN210058 | ELEOSx Limb Salvage System Onkos Surgical | QZZ |
| Jan 30, 2023 | K223348 | My3D® Personalized Pelvic Reconstruction Onkos Surgical, Inc. | LPH |
| Jul 6, 2022 | K212815 | My3D® Personalized Pelvic Reconstruction Onkos Surgical | LPH |
| Jul 28, 2021 | K211677 | ELEOS Limb Salvage System Onkos Surgical | KRO |
| Jun 9, 2021 | K203815 | ELEOS Limb Salvage System with BioGrip Onkos Surgical | JDI |
| Feb 5, 2021 | K203588 | ELEOS Limb Salvage System Onkos Surgical | JDI |
| Dec 11, 2020 | K203090 | ELEOS Limb Salvage System featuring BIOGRIP Onkos Surgical | JDI |
| Feb 23, 2018 | K180130 | ELEOS Bipolar Acetabular System Onkos Surgical, Inc. | KWY |
| Oct 28, 2016 | K161520 | ELEOS Limb Salvage System Onkos Surgical, Inc. | KRO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2026 | Onkos Surgical, Inc. Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left
REF PV-ACREC-04M Open, Classified |
LPH | K212815 K223348 |
| Oct 6, 2026 | Onkos Surgical, Inc. Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left
REF PV-ACREC-04M Open, Classified |
LPH | K212815 K223348 |
| Aug 25, 2025 | Onkos Surgical, Inc. ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants. Open, Classified |
JDI | K161520 K203588 |
| 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 | K161520 K203588 |
| Aug 25, 2025 | Onkos Surgical, Inc. ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants. Open, Classified |
JDI | K161520 K203588 |
| Jun 27, 2025 | Onkos Surgical, Inc. My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003.
It is a component of a Custom Constrained Shoulder Arthroplasty Device Open, Classified |
QHQ | 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 | K161520 |
| 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 | K203815 |
| 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 | K161520 |
| 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 | K161520 |
| May 29, 2025 | Onkos Surgical, Inc. 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 Open, Classified |
KRO | 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 | K161520 |
| May 28, 2025 | Onkos Surgical, Inc. ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E.
Component of ELEOS Limb Salvage System Open, Classified |
KRO | K161520 |
| 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 | K203815 |
| 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 | K203815 |
| 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 | K161520 |
| 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 | K161520 |
| 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 | K161520 |