510(k) · Cleared
ClearedOdc B2 Bipolar Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corp. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Oct 7, 1998 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 7, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 ODC™ B2 Bipolar Cup for the Primaloc™ Hip System is intended for single-use cementless implantation during primary or revision arthroplasty surgery. The bipolar cup allows for primary articulation between the acetabulum and femoral stem to restore patient mobility. Indications for use are: Osteoarthritis, rheumatoid arthritis, or other osteoarthrosis of the hip joint; Certain femoral neck fractures or dislocations; Post-traumatic arthritis…
Read the full statement (108 words)
The ODC™ B2 Bipolar Cup for the Primaloc™ Hip System is intended for single-use cementless implantation during primary or revision arthroplasty surgery. The bipolar cup allows for primary articulation between the acetabulum and femoral stem to restore patient mobility. Indications for use are:
Osteoarthritis, rheumatoid arthritis, or other osteoarthrosis of the hip joint;
Certain femoral neck fractures or dislocations;
Post-traumatic arthritis;
Idiopathic avascular necrosis of the femoral head,
Benign or malignant bone tumors where sufficient bone stock exists to seat the prosthesis;
Previously failed surgery
The ODC™ B2 Bipolar Cup may be used with the Primaloc™ Cementless Hip System, which is cleared for use under Premarket Notification K953977.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982389: Odc B2 Bipolar Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982389
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026