510(k) · Cleared
Recalled · 2007Gladiator Bipolar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Sep 29, 2006 after an 18-day review. The FDA summary names no predicate by number. 10 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 29, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 6
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK062693 Gladiator Bipolar SystemWrightmedicaltechnologyinc · 2006
- Descendant · cites it directly · 5 of its ownK101670 United U2 Bipolar ImplantUnited Orthopedic Corp. · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK152439 U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016
- Descendant · cites it directly · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
- Descendant · 3 generations on · 1 of its ownK162957 U2 Femoral HeadUnited Orthopedic Corporation · 2017
- Descendant · cites it directly · 0 of its ownK240046 Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K101670United U2 Bipolar ImplantUnited Orthopedic Corp. · 2010 · cites it directly5descendants
- K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016 · 2 generations on3descendants
- K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · cites it directly1descendant
- K162957U2 Femoral HeadUnited Orthopedic Corporation · 2017 · 3 generations on1descendant
- K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062693 | Gladiator Bipolar System | Wrightmedicaltechnologyinc | 2006 | — |
| +1 | K101670 | United U2 Bipolar Implant | United Orthopedic Corp. | 2010 | 1 |
| +2 | K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | 2016 | — |
| +1 | K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) | 2018 | — |
| +3 | K162957 | U2 Femoral Head | United Orthopedic Corporation | 2017 | — |
| +1 | K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2007 | Not classified | Z-0572-2007 | Other | Product specification failure which could result in improper locking of the cup onto the femoral head. |
| Jan 3, 2007 | Not classified | Z-0569-2007 | Other | Product specification failure which could result in improper locking of the cup onto the femoral head. |
| Jan 3, 2007 | Not classified | Z-0570-2007 | Other | Product specification failure which could result in improper locking of the cup onto the femoral head. |
| Jan 3, 2007 | Not classified | Z-0571-2007 | Other | Product specification failure which could result in improper locking of the cup onto the femoral head. |
| Jan 3, 2007 | Not classified | Z-0567-2007 | Other | Product specification failure which could result in improper locking of the cup onto the femoral head. |
| Jan 3, 2007 | Not classified | Z-0568-2007 | Other | Product specification failure which could result in improper locking of the cup onto the femoral head. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101670 (United Orthopedic Corp., 2010) has gone furthest, with 5 descendants of its own.
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.
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 GLADIATOR TM Bipolar 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 in the young involving the femoral head but with a non-deformed acetabulum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062693: Gladiator Bipolar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062693
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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