510(k) · Cleared
Recalled · Class II · 2020Osteovation CMF Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Kinetics, LLC · GXP Methyl Methacrylate For Cranioplasty
Cleared on Jul 20, 2005 as substantially equivalent to K051123 (Skeletal Kinetics, LLC, 2005) and 1 other predicate after a 19-day review. Its family tree reaches back 7 generations to 1987. 2 later devices descend from it. It has been recalled 13 times.
- Decided
- Jul 20, 2005
- Review
- 19 days
- Class
- Class II
- Product code
- GXP
- Recalls
- 13
- Predicates
- 2
Its longest line of descent runs back 7 generations to K873689 (1987). 17 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 6 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 5 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 4 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 3 generations backK021440 Bonesource HacStryker Instruments · 2002
- 2 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- 1 generation backK042072 Callos CMF Bone Void FillerSkeletal Kinetics, LLC · 2004 · Recalled
- This deviceK051784 Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC · 2005
- Descendant · cites it directly · 1 of its ownK162864 OsteoVation ImpactSkeletal Kinetics, LLC · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK182742 DB-CMFDimensional Bioceramics, LLC · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −6 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −5 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −4 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −3 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −2 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| −1 | K042072 | Callos CMF Bone Void Filler | Skeletal Kinetics, LLC | 2004 | 10 |
| 0 (this device) | K051784 | Osteovation CMF Bone Void Filler | Skeletal Kinetics, LLC | 2005 | — |
| +1 | K162864 | OsteoVation Impact | Skeletal Kinetics, LLC | 2017 | 7 |
| +2 | K182742 | DB-CMF | Dimensional Bioceramics, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 GXP? 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 GXP device
- #1 K241027 Permatage Settable Bone Puttyscore 16.5 · 9 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 |
|---|---|---|---|
| * | K051123 | Callos Impact and Inject Bone Void FillerSummary page 1…Hydroxyapatite Cement Classification Name: 84 GXP Predicate Devices Callos Bone Void Filler K051123; cleared on June 3,2005 Callos CMF Bone Void Filler K042072; cleared on Sept. 16, 2004 Product Description… | 2005 |
| * | K042072 | Callos CMF Bone Void FillerSummary page 1…84 GXP Predicate Devices Callos Bone Void Filler K051123; cleared on June 3,2005 Callos CMF Bone Void Filler K042072; cleared on Sept. 16, 2004 Product Description OsteoVation is a calcium phosphate bone void filler which can either be injected o… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162864 | OsteoVation Impact | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2020 | Class II | Z-2619-2020 | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include… |
| Apr 6, 2020 | Class II | Z-2616-2020 | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include… |
| Apr 6, 2020 | Class II | Z-2617-2020 | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include… |
| Apr 6, 2020 | Class II | Z-2614-2020 | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include… |
| Apr 6, 2020 | Class II | Z-2615-2020 | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include… |
| Apr 6, 2020 | Class II | Z-2618-2020 | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include… |
| Apr 2, 2020 | Class II | Z-2187-2020 | Vendor change control | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. |
| Apr 2, 2020 | Class II | Z-2189-2020 | Vendor change control | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. |
| Apr 2, 2020 | Class II | Z-2188-2020 | Vendor change control | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. |
| Apr 2, 2020 | Class II | Z-2190-2020 | Vendor change control | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. |
| Apr 2, 2020 | Class II | Z-2191-2020 | Vendor change control | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. |
| Jun 6, 2019 | Class II | Z-0867-2021 | Labeling Change Control | A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received. |
| Jun 6, 2019 | Class II | Z-0866-2021 | Labeling Change Control | A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K162864 (Skeletal Kinetics, LLC, 2017) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K051123.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXP
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GXP
87in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXP
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXP
1in 2025
MAUDE reports naming product code GXP, 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 | 3 | 87 | 0 | 8 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 1 | 22 |
| 2010 | 1 | — | 0 | 59 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 1 | 28 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 1 | — | 2 | 9 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 4 | 85 | 0 | — |
What is it indicated for?
OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm 2. OsteoVation CMF Bone Void Filler may be used in tile restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051784: Osteovation CMF Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051784
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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