ELEOS Limb Salvage System featuring BIOGRIP
FDA 510(k) K203090 · Onkos Surgical
510(k) numberK203090
Submission
- Device name
- ELEOS Limb Salvage System featuring BIOGRIP
- Applicant
- Onkos Surgical
Parsippany, NJ, US - Received
- October 13, 2020
- Decision date
- December 11, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and AugmentsJDI · Traditional | Biomet Orthopedics, Inc. | 08/24/2026SE |
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | Biomet, Inc. | 07/01/2026SE |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadJDI · Traditional | Signature Orthopaedics Pty, Ltd. | 03/12/2026SE |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersJDI · Traditional | Zimmer Biomet | 07/31/2025SE |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…JDI · Traditional | Smith & Nephew, Inc. | 10/21/2024SE |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 08/02/2024SE |
| K240418 | Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/12/2024SE |
| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/26/2023SE |
| K220216 | C-Stem AMT LE ProsthesisJDI · Traditional | Depuy Ireland UC | 07/22/2022SE |
More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K253066 | ELEOS with NanoCept® Technology Limb Salvage SystemQZZ · Traditional | 06/08/2026SE |
| K252920 | ELEOS Limb Salvage System with NanoCept® TechnologyQZZ · Special | 10/15/2025SE |
| K223348 | My3D® Personalized Pelvic ReconstructionLPH · Traditional | 01/30/2023SE |
| K212815 | My3D® Personalized Pelvic ReconstructionLPH · Traditional | 07/06/2022SE |
| K211677 | ELEOS Limb Salvage SystemKRO · Traditional | 07/28/2021SE |
| K203815 | ELEOS Limb Salvage System with BioGripJDI · Traditional | 06/09/2021SE |
| K203588 | ELEOS Limb Salvage SystemJDI · Traditional | 02/05/2021SE |
| K180130 | ELEOS Bipolar Acetabular SystemKWY · Traditional | 02/23/2018SE |
| K161520 | ELEOS Limb Salvage SystemKRO · Traditional | 10/28/2016SE |
Questions and answers
When was ELEOS Limb Salvage System featuring BIOGRIP cleared by the FDA?
ELEOS Limb Salvage System featuring BIOGRIP (K203090) received a 510(k) decision of Substantially Equivalent on December 11, 2020, 59 days after the submission was received.
What is the product code of K203090?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.