510(k) · Cleared
ClearedCobalt G HV Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LOD Bone Cement
Cleared on Aug 3, 2005 as substantially equivalent to K030086 (Biomet, Inc., 2003) and 1 other predicate after a 55-day review. Its family tree reaches back 2 generations to 1984. 23 later devices descend from it.
- Decided
- Aug 3, 2005
- Review
- 55 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P810020 (1984). 3 ancestors in all. 23 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 1 generation backK030086 Palacos R Bone Cement with GentamicinBiomet, Inc. · 2003
- This deviceK051532 Cobalt G HV Bone CementBiomet, Inc. · 2005
- Descendant · cites it directly · 20 of its ownK062273 Spacer-G Temporary Hip ProsthesisTecres S.P.A. · 2008
- Descendant · 2 generations on · 19 of its ownK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
- Descendant · 3 generations on · 16 of its ownK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
- Descendant · 4 generations on · 5 of its ownK183017 Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019
- Descendant · 4 generations on · 5 of its ownK173967 Remedy Acetabular CupOsteoremedies, LLC · 2018
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K062273Spacer-G Temporary Hip ProsthesisTecres S.P.A. · 2008 · cites it directly20descendants
- K101356Spacer-G and Spacer-KTecres S.P.A. · 2011 · 2 generations on19descendants
- K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012 · 3 generations on16descendants
- K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019 · 4 generations on5descendants
- K173967Remedy Acetabular CupOsteoremedies, LLC · 2018 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −1 | K030086 | Palacos R Bone Cement with Gentamicin | Biomet, Inc. | 2003 | — |
| 0 (this device) | K051532 | Cobalt G HV Bone Cement | Biomet, Inc. | 2005 | — |
| +1 | K062273 | Spacer-G Temporary Hip Prosthesis | Tecres S.P.A. | 2008 | — |
| +2 | K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011 | — |
| +3 | K112470 | 2GC Hip/Knee Modular Spacer | Mandell Horwitz Consultants, LLC | 2012 | — |
| +4 | K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | 2019 | — |
| +4 | K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 6 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K030086 | Palacos R Bone Cement with GentamicinSummary page 1…PMMA Bone Cement Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Predicate Device: Palacos®RG Bone Cement Cleared by: Biomet 5 10(k) Notification (K030086) Manufacturer: Biomet Inc.; 56 East Bel] Drive; Warsaw, IN 46582 Predicate Device: Generation 4®g Bone Cement Cleared by: 510(k)… | 2003 |
| * | K993836 | Generation 4 Bone CementSummary page 1…(k) Notification (K030086) Manufacturer: Biomet Inc.; 56 East Bel] Drive; Warsaw, IN 46582 Predicate Device: Generation 4®g Bone Cement Cleared by: 510(k) Notification (K993836) Manufacturer: Biomet Inc.; 56 East Bell Drive; Warsaw, IN 46582 (Relevant to packaging and sterilization processes cleared for t… | 2001 |
What descends from it? (23)
See all 232 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?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 19.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K062273 (Tecres S.P.A., 2008) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K030086.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
CobaItTM G HV Bone Cement is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051532: Cobalt G HV 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/K051532
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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