510(k) · Cleared
ClearedG3 40 Radiopaque Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G21, S.R.L. · LOD Bone Cement
Cleared on Mar 19, 2020 as substantially equivalent to K030902 (Heraeus Kulzer GmbH & Co. KG, 2003) and 1 other predicate after a 139-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- Mar 19, 2020
- Review
- 139 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to P810020 (1984). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 5 generations backK023012 Smartset HV Bone CementDePuy Orthopaedics, Inc. · 2003
- 4 generations backK033563 Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · Recalled
- 3 generations backK041656 Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV…DePuy Orthopaedics, Inc. · 2004
- 2 generations backK053002 Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005
- 1 generation backK173494 OrthoSteady G Bone CementG21, S.R.L. · 2018
- This deviceK193061 G3 40 Radiopaque Bone CementG21, S.R.L. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −5 | K023012 | Smartset HV Bone Cement | DePuy Orthopaedics, Inc. | 2003 | — |
| −4 | K033563 | Smartset GHV Gentamicin Bone Cement | DePuy Orthopaedics, Inc. | 2004 | 1 |
| −3 | K041656 | Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance… | DePuy Orthopaedics, Inc. | 2004 | — |
| −2 | K053002 | Depuy CMW 1 Gentamicin Bone Cement | DePuy Orthopaedics, Inc. | 2005 | — |
| −1 | K173494 | OrthoSteady G Bone Cement | G21, S.R.L. | 2018 | — |
| 0 (this device) | K193061 | G3 40 Radiopaque Bone Cement | G21, S.R.L. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 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 LOD? 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 LOD device
- #1 K254107 Refobacin Bone Cement R (110034355)score 11.8 · 3 generations · 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 |
|---|---|---|---|
| * | K030902 | Palacos RSummary page 4…ory Class: Class II Product codes LOD III. PREDICATE DEVICES Primary Predicate Device: Heraeus Kulzer Palacos R (K030902) Additional Predicate: G21 OrthoSteady G (K173494)… | 2003 |
| * | K173494 | OrthoSteady G Bone CementSummary page 4…LOD III. PREDICATE DEVICES Primary Predicate Device: Heraeus Kulzer Palacos R (K030902) Additional Predicate: G21 OrthoSteady G (K173494) K193061… | 2018 |
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?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 12 ancestors have a recall of any class.
- 8 other devices also cite its predicate K030902.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LOD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOD
277in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOD
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOD
355in 2025
MAUDE reports naming product code LOD, 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 | 2 | — | 0 | 78 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 3 | 103 | 0 | 170 |
| 2010 | 0 | — | 0 | 291 |
| 2011 | 0 | — | 0 | 428 |
| 2012 | 0 | — | 0 | 412 |
| 2013 | 2 | — | 0 | 501 |
| 2014 | 1 | — | 1 | 465 |
| 2015 | 4 | 138 | 0 | 529 |
| 2016 | 1 | — | 0 | 615 |
| 2017 | 3 | 96 | 4 | 817 |
| 2018 | 2 | — | 0 | 1,295 |
| 2019 | 4 | 90 | 0 | 2,307 |
| 2020 | 3 | 139 | 1 | 1,294 |
| 2021 | 4 | 95 | 0 | 782 |
| 2022 | 3 | 277 | 2 | 472 |
| 2023 | 2 | — | 0 | 475 |
| 2024 | 1 | — | 0 | 492 |
| 2025 | 1 | — | 0 | 355 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
G3 40 Radiopaque Bone Cement is intended for use in arthroplasty procedures of the hip, knee, ankle, shoulder and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
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/K193061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193061: G3 40 Radiopaque Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193061
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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