Chrysalis Intelligence · Sponsors · Onkos Surgical

Onkos Surgical

Parsippany, NJ, US · 9 510(k) clearances · 13 recalls

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Total clearances
9
2020-12-11 → 2026-06-08
Last 12 months
2
Product codes
4
Most recent
2026-06-08
Name variants in FDA filings: Onkos Surgical, Inc. / Onkos Surgical
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QZZ Limb And Joint Salvage Device With Coating For Bacteria Reduction Class II Orthopedic 3 2026-06-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class II Orthopedic 3 2021-06-09
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class II Orthopedic 2 2023-01-30
KRO — — — 1 2021-07-28
Safety

Recalls (13)

Class I (serious)
0
Risk of injury / death
Total recalls
13
Currently ongoing
13
Most recent
2025-07-11
DateSeverityStatusRecall # ProductCodeReason
2025-07-11 Class II Ongoing Z-2425-2025 ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants. — Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
2025-07-11 Class II Ongoing Z-2424-2025 ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filli… — Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
2025-07-11 Class II Ongoing Z-2423-2025 ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants. — Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
2025-05-20 Class II Ongoing Z-2042-2025 My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Sho… — Required inspections were not performed on finished product prior to release and distribution.
2024-09-22 Class II Ongoing Z-1857-2025 ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System — Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
2023-12-22 Class II Ongoing Z-1818-2025 ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with… — 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 st…
2023-12-22 Class II Ongoing Z-1817-2025 ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with… — 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 st…
2023-09-01 Class II Ongoing Z-1884-2025 Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Num… — Potential for breach of Tyvek seals.
2023-09-01 Class II Ongoing Z-1883-2025 Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03… — Potential for breach of Tyvek seals.
2023-09-01 Class II Ongoing Z-1882-2025 Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03… — Potential for breach of Tyvek seals.
2023-09-01 Class II Ongoing Z-1881-2025 Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-1412… — Potential for breach of Tyvek seals.
2023-09-01 Class II Ongoing Z-1880-2025 Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. … — Potential for breach of Tyvek seals.
2023-09-01 Class II Ongoing Z-1879-2025 a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, C… — Potential for breach of Tyvek seals.
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2026-06-08 K253066 ELEOS™ with NanoCept® Technology Limb Salvage System QZZ Class II Orthopedic
2025-10-15 K252920 ELEOS™ Limb Salvage System with NanoCept® Technology QZZ Class II Orthopedic
2024-04-05 DEN210058 ELEOSx™ Limb Salvage System QZZ Class II Orthopedic
2023-01-30 K223348 My3D® Personalized Pelvic Reconstruction LPH Class II Orthopedic
2022-07-06 K212815 My3D® Personalized Pelvic Reconstruction LPH Class II Orthopedic
2021-07-28 K211677 ELEOS Limb Salvage System KRO — —
2021-06-09 K203815 ELEOS Limb Salvage System with BioGrip JDI Class II Orthopedic
2021-02-05 K203588 ELEOS™ Limb Salvage System JDI Class II Orthopedic
2020-12-11 K203090 ELEOS Limb Salvage System featuring BIOGRIP JDI Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence