510(k) · Cleared
ClearedP.F.C. Bipolar Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Orthopaedics, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Jun 9, 1994 after a 430-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jun 9, 1994
- Review
- 430 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 4 citing it directly.
- This deviceK931655 P.F.C. Bipolar Hip SystemJohnson & Johnson Orthopaedics, Inc. · 1994
- Descendant · cites it directly · 4 of its ownK100761 Biopro Polar HeadBiopro, Inc. · 2010 · Recalled
- Descendant · cites it directly · 4 of its ownK100151 Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM)…Omnlife Science · 2010
- Descendant · 2 generations on · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
- Descendant · 2 generations on · 1 of its ownK191297 iNSitu Bipolar Hip SystemTheken Companies, LLC · 2019 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K100761Biopro Polar HeadBiopro, Inc. · 2010 · cites it directly4descendants
- K100151Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM)Omnlife Science · 2010 · cites it directly4descendants
- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · 2 generations on2descendants
- K241472Icona Hip StemCorin U.S.A. Limited · 2024 · 3 generations on1descendant
- K191297iNSitu Bipolar Hip SystemTheken Companies, LLC · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931655 | P.F.C. Bipolar Hip System | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| +1 | K100761 | Biopro Polar Head | Biopro, Inc. | 2010 | 1 |
| +1 | K100151 | Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44… | Omnlife Science | 2010 | — |
| +2 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
| +3 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
| +2 | K191297 | iNSitu Bipolar Hip System | Theken Companies, LLC | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2010 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (12)
See all 124 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, K100761 (Biopro, Inc., 2010) has gone furthest, with 4 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/K931655 · printed Nov 5, 2026
Cite this page
510(k) Report. “K931655: P.F.C. Bipolar Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K931655
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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