510(k) · Cleared
Recalled · Class II · 2017Cobalt 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 4, 2005 as substantially equivalent to P810020 (Smith & Nephew Richards, Inc., 1984) and 1 other predicate after a 59-day review. Its family tree reaches back 1 generation to 1984. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 4, 2005
- Review
- 59 days
- Class
- Class II
- Product code
- LOD
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 1 generation to P810020 (1984). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- This deviceK051496 Cobalt Bone CementBiomet, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK091608 Cobalt MV Bone CementBiomet Manufacturing Corp · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK192394 Hi-Fatigue Bone CementOsartis GmbH · 2019
- Descendant · cites it directly · 0 of its ownK070015 Cobalt V Radiopaque Vertebroplasty Bone CementBiomet Manufacturing Corp · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| 0 (this device) | K051496 | Cobalt Bone Cement | Biomet, Inc. | 2005 | — |
| +1 | K091608 | Cobalt MV Bone Cement | Biomet Manufacturing Corp | 2009 | 2 |
| +2 | K192394 | Hi-Fatigue Bone Cement | Osartis GmbH | 2019 | — |
| +1 | K070015 | Cobalt V Radiopaque Vertebroplasty Bone Cement | Biomet Manufacturing Corp | 2007 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | P810020 | Palacos R Bone CementSummary page 1…e: CobaltTm HV Bone Cement Common Name: Bone Cement Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Device: Palacosg R Bone Cement Approved by-M (P810020, SOO I. S002, S003, S004) reclassified into Class 11 Manufacturer: Biornet Inc.; 56 East Bell Drive; Warsaw, IN 46582 Predicate… | 1984 |
| * | K993836 | Generation 4 Bone CementSummary page 1…classified into Class 11 Manufacturer: Biornet Inc.; 56 East Bell Drive; Warsaw, IN 46582 Predicate Device: Generation 4®R Bone Cement Cleared by: 5 10(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? (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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2017 | Class II | Z-0067-2018 | Vendor change control | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. |
| Jun 26, 2017 | Class II | Z-0064-2018 | Vendor change control | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. |
| Apr 13, 2017 | Class II | Z-2056-2017 | Under Investigation by firm | Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device. |
| Jul 26, 2016 | Class II | Z-2606-2016 | Labeling mix-ups | The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
CobaltTM HV 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 of 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/K051496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051496: Cobalt 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/K051496
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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