510(k) · Cleared
ClearedELEOS™ Bipolar Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onkos Surgical, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Feb 23, 2018 as substantially equivalent to K062693 (Wrightmedicaltechnologyinc, 2006) after a 37-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Feb 23, 2018
- Review
- 37 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062693 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK062693 Gladiator Bipolar SystemWrightmedicaltechnologyinc · 2006 · Recalled
- This deviceK180130 ELEOS™ Bipolar Acetabular SystemOnkos Surgical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062693 | Gladiator Bipolar System | Wrightmedicaltechnologyinc | 2006 | 6 |
| 0 (this device) | K180130 | ELEOS™ Bipolar Acetabular System | Onkos Surgical, Inc. | 2018 | — |
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 KWY? 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 KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K062693 | Gladiator Bipolar SystemSummary page 4…Metal/Polymer, Cemented or uncemented – Class II Regulatory Class: II Product Code: KWY III. PREDICATE DEVICE GLADIATOR® Bipolar System, K062693 Reference Device: EVOLUTION Cementless Femur, K140735 IV. DEVICE DESCRIPTION ELEOS™ Bipolar Acetabular System is a bipolar hi… | 2006 |
| † | K140735 | Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K062693.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, 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 | 0 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ELEOS™ Bipolar Acetabular System is indicated for the following conditions:
1) pathological fractures of the femoral neck
2) non-union of femoral neck fractures
3) aseptic necrosis of the femoral head and neck
4) primary pathology involving the femoral head or femur but with a non-deformed acetabulum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180130 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180130: ELEOS™ Bipolar Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180130
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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