510(k) · Cleared
ClearedDurasul Bipolar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centerpulse Orthopedics, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Aug 27, 2004 as substantially equivalent to K873815 (Intermedics Orthopedics, 1987) after a 137-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Aug 27, 2004
- Review
- 137 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K873815 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK873815 Ioi Bipolar ProsthesisIntermedics Orthopedics · 1987
- This deviceK040947 Durasul BipolarCenterpulse Orthopedics, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873815 | Ioi Bipolar Prosthesis | Intermedics Orthopedics | 1987 | — |
| 0 (this device) | K040947 | Durasul Bipolar | Centerpulse Orthopedics, Inc. | 2004 | — |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K873815 | Ioi Bipolar ProsthesisSummary page 1…ncemented Prosthesis (87 KWY) are Class 1Iper 21 CFR §888.3390. PREDICATE DEVICES: * Centerpulse Orthopedics, Inc. Bipolar (K873815) and * Exactech's AcuMatchLU-Series Bipolar (KOl13211). DEVICE DESCRIPTION: The Durasul Bipolar consists of a poly… | 1987 |
| Kept off the family tree | K011321 | FDA’s K011321 is Modification to XPS 3000 System Our reading of the summary gave K011321, FDA’s number for Modification to XPS 3000 System (Medtronic Xomed, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Exactech's AcuMatchLU-Series Bipolar”. Kept off the family tree. | 2001 |
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.
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 Durasul Bipolar is intended for non-cemented use in a hip hemi-arthroplasty in which it assumes the function of the natural femoral head in conjunction with a prosthetic femoral head component. Specific diagnostic indications for use of a bipolar include displaced femoral neck fractures, avascular necrosis of the femoral head, and non-union of femoral neck fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040947 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040947: Durasul Bipolar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040947
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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