510(k) · Cleared
ClearedJ-FX Bipolar Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on May 29, 1998 as substantially equivalent to K945793 (Johnson & Johnson Professionals, Inc., 1995) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- May 29, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K931655 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK931655 P.F.C. Bipolar Hip SystemJohnson & Johnson Orthopaedics, Inc. · 1994
- This deviceK980801 J-FX Bipolar HeadJohnson & Johnson Professionals, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931655 | P.F.C. Bipolar Hip System | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| 0 (this device) | K980801 | J-FX Bipolar Head | Johnson & Johnson Professionals, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K945793 | P.F.C.(R) Bipolar Hip System - 22MM BipolarSummary page 1…tement of Substantial Equivalence The J-FX Bipolar Head is substantially equivalent to the P.F.C.®Bipolar Hip System cleared for marketing under premarket notifications K945793 (April 10, 1995)/ K931655 (June 9, 1994). The devices are identical in material, with the outer shell composed of cobalt-chrome a… | 1995 |
| * | K931655 | P.F.C. Bipolar Hip SystemSummary page 1…valence The J-FX Bipolar Head is substantially equivalent to the P.F.C.®Bipolar Hip System cleared for marketing under premarket notifications K945793 (April 10, 1995)/ K931655 (June 9, 1994). The devices are identical in material, with the outer shell composed of cobalt-chrome alloy and the inner liner c… | 1994 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K945793.
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 J-FX Bipolar Head is indicated for use in partial hip replacement procedures for patients suffering severe pain and disability due to:
femoral fracture
avascular necrosis of the femoral head
osteoarthritis
other abnormalities:
— where the major pathology affects the femoral head,
— where the acetabular cavity is normal and not deformed or weakened, and
— where acetabular replacement is not required or desirable.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980801: J-FX Bipolar Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980801
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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