510(k) · Cleared
Recalled · Class II · 2020Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Kinetics, LLC · MQV Filler, Bone Void, Calcium Compound
Cleared on Jul 20, 2010 as substantially equivalent to K082918 (Medtronic Sofamor Danek, 2009) and 4 other predicates after a 102-day review. Its family tree reaches back 6 generations to 1999. It has been recalled 11 times.
- Decided
- Jul 20, 2010
- Review
- 102 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 11
- Predicates
- 5
Its longest line of descent runs back 6 generations to K990131 (1999). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 5 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 4 generations backK032268 MBCPBiomatlante · 2003
- 3 generations backK043005 Modification to MBCPBiomatlante · 2005
- 2 generations backK051885 MBCPBiomatlante · 2005
- 1 generation backK082917 Mastergraft Resorbable Ceramic GranulesMedtronic Sofamor Danek · 2009
- This deviceK100986 Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler…Skeletal Kinetics, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −5 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −4 | K032268 | MBCP | Biomatlante | 2003 | — |
| −3 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −2 | K051885 | MBCP | Biomatlante | 2005 | — |
| −1 | K082917 | Mastergraft Resorbable Ceramic Granules | Medtronic Sofamor Danek | 2009 | — |
| 0 (this device) | K100986 | Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation | Skeletal Kinetics, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 MQV? 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 MQV device
- #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K082918 | Mastergraft Resorbable Ceramic GranulesSummary page 1…tially equivalent in safety and effectiveness to the following legally marketed devices (predicates): I. MasterGraft®D Resorbable Ceramic Granules of Medtronic (K0829 18) II. MasterGraft®& Resorbable Ceramic Granules of Medtronic (K0829 17) III. MBCPTM of Biomatlante (KO5 1774) LV.… | 2009 |
| * | K082917 | Mastergraft Resorbable Ceramic GranulesSummary page 1…ed devices (predicates): I. MasterGraft®D Resorbable Ceramic Granules of Medtronic (K0829 18) II. MasterGraft®& Resorbable Ceramic Granules of Medtronic (K0829 17) III. MBCPTM of Biomatlante (KO5 1774) LV. Callos®R of Skeletal Kinetics (K030554 and KO0i1123)… | 2009 |
| * | K051774 | MBCP | 2006 |
| * | K030554 | CallosSummary page 1…29 18) II. MasterGraft®& Resorbable Ceramic Granules of Medtronic (K0829 17) III. MBCPTM of Biomatlante (KO5 1774) LV. Callos®R of Skeletal Kinetics (K030554 and KO0i1123) Page I of 3 Device Description as req uired by 21 CFR 8… | 2003 |
| * | K051123 | Callos Impact and Inject Bone Void FillerSummary page 2…SI!AAMII/ISO 11 137-2:2006, Sterilization of Health Care Products - Radiation - Establishingthe Sterilization Dose. These tests were evaluated during Callos® K030554 and K051 123 clearances. Callos is a previously cleared and commercially marketed calcium phosphate bone void filler. The physical/mechanical… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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-2596-2020 | 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-2612-2020 | 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-2613-2020 | 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-2625-2020 | 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-2595-2020 | 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-2626-2020 | 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-2608-2020 | 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-2624-2020 | 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-2609-2020 | 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-2186-2020 | 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-2185-2020 | 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. |
The 5 latest of 11 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 11 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
How does its category compare?
All MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MQV
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQV
57in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQV
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQV
57in 2025
MAUDE reports naming product code MQV, 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 | 35 | 144 | 5 | 67 |
| 2008 | 32 | 102 | 3 | 71 |
| 2009 | 23 | 180 | 1 | 81 |
| 2010 | 17 | 147 | 0 | 68 |
| 2011 | 16 | 92 | 6 | 114 |
| 2012 | 9 | 107 | 3 | 149 |
| 2013 | 12 | 197 | 2 | 223 |
| 2014 | 20 | 153 | 0 | 111 |
| 2015 | 18 | 184 | 0 | 125 |
| 2016 | 8 | 214 | 1 | 106 |
| 2017 | 17 | 124 | 1 | 107 |
| 2018 | 23 | 124 | 2 | 86 |
| 2019 | 13 | 90 | 0 | 65 |
| 2020 | 15 | 132 | 1 | 126 |
| 2021 | 8 | 88 | 0 | 101 |
| 2022 | 9 | 118 | 0 | 47 |
| 2023 | 21 | 74 | 3 | 120 |
| 2024 | 28 | 55 | 2 | 68 |
| 2025 | 14 | 57 | 1 | 57 |
| 2026 | 5 | 96 | 4 | — |
What is it indicated for?
Callos Bone Void Filler is indicated to the following indications:
1 To fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis) not intrinsic to the stability of the bony structure. These defects may be suigically created osseous defects or osseous defects created from traumatic injury to the bone.
2. To be used with autograft as a bone graft extender (i e extremities, and pelvis only).
Callos resoibs and is replaced by bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100986: Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100986
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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