510(k) · Cleared
Recalled · Class II · 2017Cobalt MV Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · LOD Bone Cement
Cleared on Sep 17, 2009 as substantially equivalent to K051496 (Biomet, Inc., 2005) after a 106-day review. Its family tree reaches back 2 generations to 1984. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Sep 17, 2009
- Review
- 106 days
- Class
- Class II
- Product code
- LOD
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to P810020 (1984). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 1 generation backK051496 Cobalt Bone CementBiomet, Inc. · 2005 · Recalled
- This deviceK091608 Cobalt MV Bone CementBiomet Manufacturing Corp · 2009
- Descendant · cites it directly · 0 of its ownK192394 Hi-Fatigue Bone CementOsartis GmbH · 2019
Most influential descendants
Showing 1 of 1 · See all- K192394Hi-Fatigue 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 |
|---|---|---|---|---|---|
| −2 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −1 | K051496 | Cobalt Bone Cement | Biomet, Inc. | 2005 | 4 |
| 0 (this device) | K091608 | Cobalt MV Bone Cement | Biomet Manufacturing Corp | 2009 | — |
| +1 | K192394 | Hi-Fatigue Bone Cement | Osartis GmbH | 2019 | — |
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 |
|---|---|---|
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051496 | Cobalt Bone CementSummary page 1…ent (21 CFR §888.3027) Product Code: LOD Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Cobalt5 m HV Bone Cement K051496 Biomet Manufacturing Corp. Simplex®g P Radiopaque Bone Cement N17004* Stryker Howmedica Osteonics, De… | 2005 |
| Kept off the family tree | K017004 | Simplex®g P Radiopaque Bone Cement Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
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 |
|---|---|---|---|
| K192394 | Hi-Fatigue Bone Cement | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2017 | Class II | Z-0066-2018 | Vendor change control | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. |
| Jun 26, 2017 | Class II | Z-0065-2018 | Vendor change control | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 21.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K192394 (Osartis GmbH, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K051496.
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?
CobaltTM MV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck,6fof the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091608: Cobalt 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/K091608
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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