510(k) · Cleared
ClearedProgeny Forged Cocr Cemented Femoral Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stelkast Company · JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Cleared on Sep 27, 2000 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Sep 27, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- JDG
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK001984 Progeny Forged Cocr Cemented Femoral ComponentStelkast Company · 2000
- Descendant · cites it directly · 0 of its ownK254043 TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001984 | Progeny Forged Cocr Cemented Femoral Component | Stelkast Company | 2000 | — |
| +1 | K254043 | TRIVANCE™ Hip Stem | Globus Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254043 | TRIVANCE™ Hip Stem | 2026 | 0 |
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, K254043 (Globus Medical, Inc., 2026) has gone furthest, with 0 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 | — |
What is it indicated for?
1. Joint impairment from arthritis (rheumatoid, osteo and posttraumatic).
2. Revision of Wed femoral head replacements.
3. When alternative reconstructive techniques are not viable.
4. When arthrodesis is contraindicated.
5. Avascular necrosis or fracture of the femoral head.
6. Congenital defects that will allow adequate fanctbn of the system
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/K001984 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001984: Progeny Forged Cocr Cemented 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/K001984
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026