510(k) · Cleared
Clearedb-ONE® Bipolar Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B-One Ortho, Corp. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Apr 13, 2026 as substantially equivalent to K812672 (Depuy, Inc., 1981) after a 195-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Apr 13, 2026
- Review
- 195 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K812672 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK812672 Self-Centering HipDepuy, Inc. · 1981
- This deviceK253357 b-ONE® Bipolar HeadB-One Ortho, Corp. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K812672 | Self-Centering Hip | Depuy, Inc. | 1981 | — |
| 0 (this device) | K253357 | b-ONE® Bipolar Head | B-One Ortho, Corp. | 2026 | — |
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 K243634 Maxx Libertas Bipolar Hip Head (Bipolar Hip)score 10.8 · 4 generations · 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 |
|---|---|---|---|
| * | K812672 | Self-Centering HipSummary page 5…gulation(s) Corresponding Predicate Predicate Device Product Code(s) K812672, DePuy Self Centering Hip 888.3390 KWY (Primary) K800207, Stryker UHR Bipolar 888.336… | 1981 |
| † | K800207 | Uhr UNIVERSAL6HIP Replacement | 1980 |
| † | K855231 | Howmedica Bipolar Prosthesis | 1986 |
| † | K972792 | Duration Stabilized Uhmwpe Acetabular Components | 1997 |
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 no recall.
- 3 other devices also cite its predicate K812672.
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. 2026, 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 Bipolar Head is intended to be used for hemi-hip arthroplasty with evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem and is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3.…
Read the full statement (129 words)
The Bipolar Head is intended to be used for hemi-hip arthroplasty with evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem and is indicated in the following conditions:
1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253357 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253357: b-ONE® Bipolar Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253357
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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