510(k) · Cleared
ClearedImpact CO-CR 1-Piece 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. 3 later devices descend from it.
- Decided
- Sep 19, 1994
- Review
- 146 days
- Class
- Class II
- Product code
- JDG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK942027 Impact CO-CR 1-Piece Femoral ComponentBiomet, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK980020 Activelock Modular Femoral Hip SystemMetagen, LLC · 1998
- Descendant · cites it directly · 1 of its ownK992815 The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2000 · Recalled
- Descendant · 2 generations on · 0 of its ownK032641 Modification to: the Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2004 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K980020Activelock Modular Femoral Hip SystemMetagen, LLC · 1998 · cites it directly2descendants
- K992815The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2000 · cites it directly1descendant
- K032641Modification to: the Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942027 | Impact CO-CR 1-Piece Femoral Component | Biomet, Inc. | 1994 | — |
| +1 | K980020 | Activelock Modular Femoral Hip System | Metagen, LLC | 1998 | — |
| +1 | K992815 | The Margron Hip Replacement System | Portland Orthopaedics Pty., Ltd. | 2000 | 71 |
| +2 | K032641 | Modification to: the Margron Hip Replacement System | Portland Orthopaedics Pty., Ltd. | 2004 | 71 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 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? (3)
2 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, K980020 (Metagen, LLC, 1998) has gone furthest, with 2 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/K942027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942027: Impact CO-CR 1-Piece 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/K942027
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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