510(k) · Cleared
ClearedHowmedica Bipolar Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Feb 27, 1986 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Feb 27, 1986
- Review
- 59 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK855231 Howmedica Bipolar ProsthesisHowmedica Corp. · 1986
- Descendant · cites it directly · 16 of its ownK972792 Duration Stabilized Uhmwpe Acetabular ComponentsHowmedica Corp. · 1997
- Descendant · 2 generations on · 15 of its ownK992153 PE-Plus Acetabular CupPlus Orthopedics · 1999
- Descendant · 3 generations on · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · 4 generations on · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
- Descendant · 4 generations on · 4 of its ownK152903 REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K972792Duration Stabilized Uhmwpe Acetabular ComponentsHowmedica Corp. · 1997 · cites it directly16descendants
- K992153PE-Plus Acetabular CupPlus Orthopedics · 1999 · 2 generations on15descendants
- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · 3 generations on13descendants
- K141327Minima S SystemLima Corporate S.P.A. · 2014 · 4 generations on5descendants
- K152903REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K855231 | Howmedica Bipolar Prosthesis | Howmedica Corp. | 1986 | — |
| +1 | K972792 | Duration Stabilized Uhmwpe Acetabular Components | Howmedica Corp. | 1997 | — |
| +2 | K992153 | PE-Plus Acetabular Cup | Plus Orthopedics | 1999 | — |
| +3 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +4 | K141327 | Minima S System | Lima Corporate S.P.A. | 2014 | — |
| +4 | K152903 | REVIVAL (TM) Modular Revision Hip Stem | Corin USA | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 182 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, K972792 (Howmedica Corp., 1997) has gone furthest, with 16 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 | — |
https://510kreport.com/device/K855231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K855231: Howmedica Bipolar Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K855231
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026