510(k) · Cleared
ClearedStelkast Bipolar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stelkast Company · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Nov 4, 1997 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it.
- Decided
- Nov 4, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK972961 Stelkast Bipolar SystemStelkast Company · 1997
- Descendant · cites it directly · 10 of its ownK112019 Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd. · 2011
- Descendant · 2 generations on · 8 of its ownK121665 Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012
- Descendant · 2 generations on · 7 of its ownK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- Descendant · 3 generations on · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
- Descendant · 3 generations on · 4 of its ownK172806 Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd. · 2011 · cites it directly10descendants
- K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012 · 2 generations on8descendants
- K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015 · 2 generations on7descendants
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 3 generations on6descendants
- K172806Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972961 | Stelkast Bipolar System | Stelkast Company | 1997 | — |
| +1 | K112019 | Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup | Corentec Co., Ltd. | 2011 | — |
| +2 | K121665 | Bencox Foret & Bencox Delta | Corentec Co., Ltd. | 2012 | — |
| +2 | K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015 | — |
| +3 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
| +3 | K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · 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? (13)
See all 132 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K112019 (Corentec Co., Ltd., 2011) has gone furthest, with 10 descendants of its own.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
1. Fractures of the proximal femur
2. Non-unions of proximal femoral neck fractures.
3. Aseptic necrosis of the femoral head.
4. Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum.
5. Salvage of failed total hip arthroplasty.
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/K972961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972961: Stelkast 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/K972961
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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