# Onkos Surgical

- Location (FDA's records): Parsippany, NJ
- FDA decisions: 11 (2016–2026): 10 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Onkos Surgical (6); Onkos Surgical, Inc. (5)
- Product codes: JDI (3), QZZ (3), LPH (2), KRO (2), KWY (1)
- 510(k) review time since 2016: median 74 days, against 162 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 17 (10 its own); citations of its devices by later devices: 10 (10 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wrightmedicaltechnologyinc: 4 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)
- Dow Corning Wright: 1 (https://510kreport.com/company/dow-corning-wright)

## Its most-cited devices
- K161520: ELEOS Limb Salvage System (2016), cited by 6
- DEN210058: ELEOSx™ Limb Salvage System (2024), cited by 2
- K203090: ELEOS Limb Salvage System featuring BIOGRIP (2020), cited by 1
- K212815: My3D® Personalized Pelvic Reconstruction (2022), cited by 1

## Recent decisions
- K253066: ELEOS™ with NanoCept® Technology Limb Salvage System (Jun 8, 2026)
- K252920: ELEOS™ Limb Salvage System with NanoCept® Technology (Oct 15, 2025)
- DEN210058: ELEOSx™ Limb Salvage System (Apr 5, 2024)
- K223348: My3D® Personalized Pelvic Reconstruction (Jan 30, 2023)
- K212815: My3D® Personalized Pelvic Reconstruction (Jul 6, 2022)
- K211677: ELEOS Limb Salvage System (Jul 28, 2021)
- K203815: ELEOS Limb Salvage System with BioGrip (Jun 9, 2021)
- K203588: ELEOS™ Limb Salvage System (Feb 5, 2021)

Source page: https://510kreport.com/company/onkos-surgical