# K161520: ELEOS Limb Salvage System

- Pathway: 510(k) (Traditional)
- Applicant: Onkos Surgical, Inc.
- Decided: Oct 28, 2016 after 148 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932222 (1994). 4 ancestors in all.
6 later devices descend from it; 6 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013035: Guardian Limb Salvage System, Wrightmedicaltechnologyinc (2001) Summary page 5.
- K973524: Advance Modular Tibial Component, Wrightmedicaltechnologyinc (1997) Summary page 5.
- K002149: Lineage Acetabular System, Wrightmedicaltechnologyinc (2000) Summary page 5.
- K932222: SLT Femoral Head, Dow Corning Wright (1994) Summary page 5.

## Most influential descendants
- K203090: ELEOS Limb Salvage System featuring BIOGRIP (2020), 1 descendant of its own
- K253066: ELEOS™ with NanoCept® Technology Limb Salvage System (2026), 0 descendants of its own
- K252920: ELEOS™ Limb Salvage System with NanoCept® Technology (2025), 0 descendants of its own
- K211677: ELEOS Limb Salvage System (2021), 0 descendants of its own
- K203815: ELEOS Limb Salvage System with BioGrip (2021), 0 descendants of its own

## Recalls of this device
- Jul 11, 2025 · Class II · Z-2425-2025: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
- Jul 11, 2025 · Class II · Z-2423-2025: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
- Jul 11, 2025 · Class II · Z-2424-2025: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
- Sep 22, 2024 · Class II · Z-1857-2025: Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
- Sep 1, 2023 · Class II · Z-1881-2025: Potential for breach of Tyvek seals.
- Sep 1, 2023 · Class II · Z-1879-2025: Potential for breach of Tyvek seals.
- Sep 1, 2023 · Class II · Z-1882-2025: Potential for breach of Tyvek seals.
- Sep 1, 2023 · Class II · Z-1884-2025: Potential for breach of Tyvek seals.
- May 23, 2017 · Class II · Z-2647-2017: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
- May 23, 2017 · Class II · Z-2648-2017: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
- May 23, 2017 · Class II · Z-2646-2017: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm

## 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 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/K161520
Methodology: https://510kreport.com/methodology