510(k) · Cleared
Recalled · Class II · 2020Callos 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 Sep 16, 2004 as substantially equivalent to K030554 (Skeletal Kinetics, LLC, 2003) and 2 other predicates after a 45-day review. Its family tree reaches back 6 generations to 1987. 3 later devices descend from it. It has been recalled 10 times.
- Decided
- Sep 16, 2004
- Review
- 45 days
- Class
- Class II
- Product code
- GXP
- Recalls
- 10
- Predicates
- 3
Its longest line of descent runs back 6 generations to K873689 (1987). 15 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 5 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 4 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 3 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 2 generations backK021440 Bonesource HacStryker Instruments · 2002
- 1 generation backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- This deviceK042072 Callos CMF Bone Void FillerSkeletal Kinetics, LLC · 2004
- Descendant · cites it directly · 2 of its ownK051784 Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC · 2005 · Recalled
- Descendant · 2 generations on · 1 of its ownK162864 OsteoVation ImpactSkeletal Kinetics, LLC · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK182742 DB-CMFDimensional Bioceramics, LLC · 2019
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 |
|---|---|---|---|---|---|
| −6 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −5 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −4 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −3 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −2 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −1 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| 0 (this device) | K042072 | Callos CMF Bone Void Filler | Skeletal Kinetics, LLC | 2004 | — |
| +1 | K051784 | Osteovation CMF Bone Void Filler | Skeletal Kinetics, LLC | 2005 | 13 |
| +2 | K162864 | OsteoVation Impact | Skeletal Kinetics, LLC | 2017 | 7 |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K030554 | CallosSummary page 1…Generic/Common Name: Hydroxyapatite Ceiment Predicate flevices Callos Bone Void Filler K030554 BoneSource 11AC (Hydroxyapatite Cement) K032366 Synthes Fast Set Putty (Norian CRS)… | 2003 |
| * | K032366 | Bonesource Hac Fast Setting CementSummary page 1…vices Callos Bone Void Filler K030554 BoneSource 11AC (Hydroxyapatite Cement) K032366 Synthes Fast Set Putty (Norian CRS) K012589 Intended Jse Callos CMF Bone Void Filler i… | 2003 |
| * | K012589 | Fast Set PuttySummary page 1…30554 BoneSource 11AC (Hydroxyapatite Cement) K032366 Synthes Fast Set Putty (Norian CRS) K012589 Intended Jse Callos CMF Bone Void Filler is a calcium phosphate bone void fillcr indicated for the repair or filling of neurosur… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051784 | Osteovation CMF Bone Void Filler | 2005 | 2 |
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-2627-2020 | 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-2628-2020 | 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-2605-2020 | 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-2600-2020 | 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-2604-2020 | 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-2602-2020 | 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-2603-2020 | 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-2629-2020 | 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-2632-2020 | 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-2601-2020 | 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… |
The 5 latest of 10 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 17 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K051784 (Skeletal Kinetics, LLC, 2005) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K030554.
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?
Callos 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. Callos CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeleton, including fronto-orbital, malar, and mental areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042072 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042072: Callos CMF Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042072
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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