# K203815: ELEOS Limb Salvage System with BioGrip

- Pathway: 510(k) (Traditional)
- Applicant: Onkos Surgical
- Decided: Jun 9, 2021 after 162 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K932222 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203090: ELEOS Limb Salvage System featuring BIOGRIP, Onkos Surgical (2020) Summary page 5.
- K161520: ELEOS Limb Salvage System, Onkos Surgical, Inc. (2016) Summary page 5.

## Recalls of this device
- Dec 22, 2023 · Class II · Z-1817-2025: 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 stated on the package. The corresponding 1
- Dec 22, 2023 · Class II · Z-1818-2025: 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 stated on the package. The corresponding 1
- Sep 1, 2023 · Class II · Z-1883-2025: Potential for breach of Tyvek seals.

## Indications for use
ELEOS™ Limb Salvage System Hip Components: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia; 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; 3) Correction of functional deformity 4) Revision procedures where other treatments or devices have failed; and, 5) Treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/or total femur is required with the following conditions: 1) Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications. 3) Metastatic diseases ELEOS™ Limb Salvage System with Knee Components: Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and 5) Treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions: 1) Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications. 3) Metastatic diseases

Source page: https://510kreport.com/device/K203815
Methodology: https://510kreport.com/methodology