510(k) · Cleared
Recalled · Class II · 2025ELEOS Limb Salvage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onkos Surgical, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Oct 28, 2016 as substantially equivalent to K013035 (Wrightmedicaltechnologyinc, 2001) and 3 other predicates after a 148-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it. It has been recalled 11 times.
- Decided
- Oct 28, 2016
- Review
- 148 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 11
- Predicates
- 4
Its longest line of descent runs back 1 generation to K932222 (1994). 4 ancestors in all. 6 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK932222 SLT Femoral HeadDow Corning Wright · 1994
- This deviceK161520 ELEOS Limb Salvage SystemOnkos Surgical, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK203090 ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical · 2020
- Descendant · cites it directly · 0 of its ownK253066 ELEOS™ with NanoCept® Technology Limb Salvage SystemOnkos Surgical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252920 ELEOS™ Limb Salvage System with NanoCept® TechnologyOnkos Surgical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK211677 ELEOS Limb Salvage SystemOnkos Surgical · 2021
- Descendant · cites it directly · 0 of its ownK203815 ELEOS Limb Salvage System with BioGripOnkos Surgical · 2021 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K203090ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical · 2020 · cites it directly1descendant
- K253066ELEOS™ with NanoCept® Technology Limb Salvage SystemOnkos Surgical, Inc. · 2026 · cites it directly0descendants
- K252920ELEOS™ Limb Salvage System with NanoCept® TechnologyOnkos Surgical, Inc. · 2025 · cites it directly0descendants
- K211677ELEOS Limb Salvage SystemOnkos Surgical · 2021 · cites it directly0descendants
- K203815ELEOS Limb Salvage System with BioGripOnkos Surgical · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932222 | SLT Femoral Head | Dow Corning Wright | 1994 | — |
| 0 (this device) | K161520 | ELEOS Limb Salvage System | Onkos Surgical, Inc. | 2016 | — |
| +1 | K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | 2020 | — |
| +1 | K253066 | ELEOS™ with NanoCept® Technology Limb Salvage System | Onkos Surgical, Inc. | 2026 | — |
| +1 | K252920 | ELEOS™ Limb Salvage System with NanoCept® Technology | Onkos Surgical, Inc. | 2025 | — |
| +1 | K211677 | ELEOS Limb Salvage System | Onkos Surgical | 2021 | — |
| +1 | K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | 2021 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KRO device
- #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013035 | Guardian Limb Salvage SystemSummary page 5…JDI/KRO JWH LPH LZO III. PREDICATE DEVICE GUARDIAN® Limb Salvage System, K013035 ADVANCE® Modular Tibial Component, K973524 LINEAGE® Acetabular System, K002149 SLT Femoral Heads, K932222 No reference devices w… | 2001 |
| * | K973524 | Advance Modular Tibial ComponentSummary page 5…JWH LPH LZO III. PREDICATE DEVICE GUARDIAN® Limb Salvage System, K013035 ADVANCE® Modular Tibial Component, K973524 LINEAGE® Acetabular System, K002149 SLT Femoral Heads, K932222 No reference devices were used in this submission. === Page 6 ==… | 1997 |
| * | K002149 | Lineage Acetabular SystemSummary page 5…H LZO III. PREDICATE DEVICE GUARDIAN® Limb Salvage System, K013035 ADVANCE® Modular Tibial Component, K973524 LINEAGE® Acetabular System, K002149 SLT Femoral Heads, K932222 No reference devices were used in this submission.… | 2000 |
| * | K932222 | SLT Femoral HeadSummary page 5…LZO III. PREDICATE DEVICE GUARDIAN® Limb Salvage System, K013035 ADVANCE® Modular Tibial Component, K973524 LINEAGE® Acetabular System, K002149 SLT Femoral Heads, K932222 No reference devices were used in this submission.… | 1994 |
What descends from it? (6)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | 2020 | 1 |
| K253066 | ELEOS™ with NanoCept® Technology Limb Salvage System | 2026 | 0 |
| K252920 | ELEOS™ Limb Salvage System with NanoCept® Technology | 2025 | 0 |
| K211677 | ELEOS Limb Salvage System | 2021 | 0 |
| K203815 | ELEOS Limb Salvage System with BioGrip | 2021 | 0 |
| K203588 | ELEOS™ Limb Salvage System | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 11, 2025 | Class II | Z-2425-2025 | Under Investigation by firm | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| Jul 11, 2025 | Class II | Z-2423-2025 | Under Investigation by firm | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| Jul 11, 2025 | Class II | Z-2424-2025 | Under Investigation by firm | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| Sep 22, 2024 | Class II | Z-1857-2025 | Nonconforming Material/Component | 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 | Packaging change control | Potential for breach of Tyvek seals. |
| Sep 1, 2023 | Class II | Z-1879-2025 | Packaging change control | Potential for breach of Tyvek seals. |
| Sep 1, 2023 | Class II | Z-1882-2025 | Packaging change control | Potential for breach of Tyvek seals. |
| Sep 1, 2023 | Class II | Z-1884-2025 | Packaging change control | Potential for breach of Tyvek seals. |
| May 23, 2017 | Class II | Z-2647-2017 | Process control | 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 | Process control | 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 | Process control | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 2025
MAUDE reports naming product code KRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 37 |
| 2008 | 3 | 126 | 3 | 44 |
| 2009 | 3 | 86 | 8 | 66 |
| 2010 | 1 | — | 0 | 110 |
| 2011 | 2 | — | 1 | 119 |
| 2012 | 2 | — | 1 | 173 |
| 2013 | 3 | 189 | 2 | 194 |
| 2014 | 2 | — | 0 | 406 |
| 2015 | 6 | 113 | 1 | 333 |
| 2016 | 3 | 148 | 5 | 369 |
| 2017 | 1 | — | 4 | 543 |
| 2018 | 0 | — | 1 | 614 |
| 2019 | 3 | 244 | 0 | 759 |
| 2020 | 1 | — | 0 | 749 |
| 2021 | 3 | 57 | 1 | 770 |
| 2022 | 1 | — | 0 | 892 |
| 2023 | 4 | 148 | 0 | 746 |
| 2024 | 3 | 87 | 0 | 855 |
| 2025 | 3 | 56 | 1 | 915 |
| 2026 | 1 | — | 14 | — |
What is it indicated for?
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…
Read the full statement (283 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161520: ELEOS Limb Salvage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161520
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026