510(k) · Cleared
ClearedCobalt MV with Gentamicin (Aka Cobalt G-MV) 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 Oct 27, 2009 as substantially equivalent to K051532 (Biomet, Inc., 2005) and 1 other predicate after a 103-day review. Its family tree reaches back 3 generations to 1984. 1 later device descends from it.
- Decided
- Oct 27, 2009
- Review
- 103 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P810020 (1984). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 2 generations backK030086 Palacos R Bone Cement with GentamicinBiomet, Inc. · 2003
- 1 generation backK051532 Cobalt G HV Bone CementBiomet, Inc. · 2005
- This deviceK092150 Cobalt MV with Gentamicin (Aka Cobalt G-MV) Bone CementBiomet, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK192379 Hi-Fatigue G Bone CementOsartis GmbH · 2019
Most influential descendants
Showing 1 of 1 · See all- K192379Hi-Fatigue G Bone CementOsartis GmbH · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −2 | K030086 | Palacos R Bone Cement with Gentamicin | Biomet, Inc. | 2003 | — |
| −1 | K051532 | Cobalt G HV Bone Cement | Biomet, Inc. | 2005 | — |
| 0 (this device) | K092150 | Cobalt MV with Gentamicin (Aka Cobalt G-MV) Bone Cement | Biomet, Inc. | 2009 | — |
| +1 | K192379 | Hi-Fatigue G Bone Cement | Osartis GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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 |
|---|---|---|---|
| * | K051532 | Cobalt G HV Bone CementSummary page 1…MBB (bone cement, antibiotic), LOD (bone cement) Legally Marketed Devices to Which Substantial Equivalence is Claimed: Cobalt TM G-HV Bone Cement K051532 Biomet Manufacturing Corp. Simplex® P with Tobramycin Bone Cement K014199 Stryker Howmedica Osteonics Device Description: Co… | 2005 |
| * | K014199 | Surgical Simplex P with TobramycinSummary page 1…Devices to Which Substantial Equivalence is Claimed: Cobalt TM G-HV Bone Cement K051532 Biomet Manufacturing Corp. Simplex® P with Tobramycin Bone Cement K014199 Stryker Howmedica Osteonics Device Description: Cobalt TM G-MV Bone Cement is a methyl methacrylate-styrene copolymer based acr… | 2003 |
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 |
|---|---|---|---|
| K192379 | Hi-Fatigue G Bone Cement | 2019 | 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?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K192379 (Osartis GmbH, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K051532.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Cobalt TM MV with Gentamicin 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/K092150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092150: Cobalt MV with Gentamicin (Aka Cobalt G-MV) 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/K092150
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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