510(k) · Cleared
ClearedRX90 Femoral Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Cleared on Sep 19, 1994 after a 146-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Sep 19, 1994
- Review
- 146 days
- Class
- Class II
- Product code
- JDG
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK942028 RX90 Femoral ComponentBiomet, Inc. · 1994
- Descendant · cites it directly · 11 of its ownK052639 Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement…Biomet Manufacturing, Inc. · 2006
- Descendant · 2 generations on · 10 of its ownK130610 Sirius Femoral StemBiomet, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 9 of its ownK142295 Sirius Femoral Stem, Size 30ABiomet, Inc. · 2014
- Descendant · 3 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- Descendant · 4 generations on · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K052639Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement SpacerBiomet Manufacturing, Inc. · 2006 · cites it directly11descendants
- K130610Sirius Femoral StemBiomet, Inc. · 2013 · 2 generations on10descendants
- K142295Sirius Femoral Stem, Size 30ABiomet, Inc. · 2014 · 3 generations on9descendants
- K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 3 generations on8descendants
- K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942028 | RX90 Femoral Component | Biomet, Inc. | 1994 | — |
| +1 | K052639 | Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer | Biomet Manufacturing, Inc. | 2006 | — |
| +2 | K130610 | Sirius Femoral Stem | Biomet, Inc. | 2013 | 2 |
| +3 | K142295 | Sirius Femoral Stem, Size 30A | Biomet, Inc. | 2014 | — |
| +3 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
| +4 | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 JDG? 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 JDG device
- #1 K212431 Biomet Answer/Impact/Integral Distal…score 3.1 · 2 generations · no Class I recall
- #2 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? (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, K052639 (Biomet Manufacturing, Inc., 2006) has gone furthest, with 11 descendants of its own.
How does its category compare?
All JDG devicesJDG Prosthesis, Hip, Femoral Component, Cemented, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDG
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JDG
Too few JDG 510(k)s in any year since 2007 to give a median.
Recalls per year · JDG
4in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDG
263in 2025
MAUDE reports naming product code JDG, 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 | — | 0 | 28 |
| 2008 | 0 | — | 0 | 19 |
| 2009 | 0 | — | 2 | 38 |
| 2010 | 0 | — | 0 | 37 |
| 2011 | 0 | — | 0 | 25 |
| 2012 | 0 | — | 0 | 49 |
| 2013 | 0 | — | 3 | 84 |
| 2014 | 0 | — | 0 | 145 |
| 2015 | 0 | — | 0 | 391 |
| 2016 | 0 | — | 0 | 383 |
| 2017 | 0 | — | 0 | 328 |
| 2018 | 1 | — | 0 | 447 |
| 2019 | 0 | — | 0 | 333 |
| 2020 | 1 | — | 0 | 1,046 |
| 2021 | 0 | — | 4 | 1,206 |
| 2022 | 1 | — | 0 | 886 |
| 2023 | 0 | — | 0 | 289 |
| 2024 | 0 | — | 0 | 300 |
| 2025 | 0 | — | 0 | 263 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K942028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942028: RX90 Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942028
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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