510(k) · Cleared
Recalled · Class II · 2020Callos Impact and Inject Bone Void Filler
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 Jun 3, 2005 as substantially equivalent to K030554 (Skeletal Kinetics, LLC, 2003) after a 31-day review. Its family tree reaches back 2 generations to 2001. 9 later devices descend from it. It has been recalled 17 times.
- Decided
- Jun 3, 2005
- Review
- 31 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 17
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011897 (2001). 9 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK011897 Norian SRS Bone Void FillerSynthes (Usa) · 2001
- 1 generation backK030554 CallosSkeletal Kinetics, LLC · 2003
- This deviceK051123 Callos Impact and Inject Bone Void FillerSkeletal Kinetics, LLC · 2005
- 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 · cites it directly · 1 of its ownK132211 Skaffold NMX Bone Void FillerSkeletal Kinetics, LLC · 2014
- Descendant · cites it directly · 1 of its ownK112383 Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone…Skeletal Kinetics, LLC · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK212353 DB-EZ Bone Void FillerDimensional Bioceramics, LLC · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K051784Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC · 2005 · cites it directly2descendants
- K162864OsteoVation ImpactSkeletal Kinetics, LLC · 2017 · 2 generations on1descendant
- K132211Skaffold NMX Bone Void FillerSkeletal Kinetics, LLC · 2014 · cites it directly1descendant
- K112383Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerSkeletal Kinetics, LLC · 2012 · cites it directly1descendant
- K212353DB-EZ Bone Void FillerDimensional Bioceramics, LLC · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011897 | Norian SRS Bone Void Filler | Synthes (Usa) | 2001 | — |
| −1 | K030554 | Callos | Skeletal Kinetics, LLC | 2003 | — |
| 0 (this device) | K051123 | Callos Impact and Inject Bone Void Filler | Skeletal Kinetics, LLC | 2005 | — |
| +1 | K051784 | Osteovation CMF Bone Void Filler | Skeletal Kinetics, LLC | 2005 | 13 |
| +2 | K162864 | OsteoVation Impact | Skeletal Kinetics, LLC | 2017 | 7 |
| +1 | K132211 | Skaffold NMX Bone Void Filler | Skeletal Kinetics, LLC | 2014 | — |
| +1 | K112383 | Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void Filler | Skeletal Kinetics, LLC | 2012 | 3 |
| +2 | K212353 | DB-EZ Bone Void Filler | Dimensional Bioceramics, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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? (1)
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…Bone Void Filler Classification Name: 87 MVQ Predicate Devices Callos Bone Void Filler K030554; cleared on May 20, 2003 Product Description Callos is a calcium phosphate bone void filler which can either be injected or dig… | 2003 |
What descends from it? (9)
5 later devices cite 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 |
| K132211 | Skaffold NMX Bone Void Filler | 2014 | 1 |
| K112383 | Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void Filler | 2012 | 1 |
| K200752 | DB-Orthopedics | 2020 | 0 |
| K100986 | Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation | 2010 | 0 |
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-2622-2020 | 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-2620-2020 | 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-2606-2020 | 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-2623-2020 | 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-2610-2020 | 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-2593-2020 | 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-2607-2020 | 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-2592-2020 | 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-2594-2020 | 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-2621-2020 | 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-2611-2020 | 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-2181-2020 | 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-2182-2020 | 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-2183-2020 | 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-2184-2020 | 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-2180-2020 | 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. |
| May 29, 2015 | Class II | Z-2209-2015 | No Marketing Application | Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler. |
The 5 latest of 17 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 4 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- 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 MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051123: Callos Impact and Inject 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/K051123
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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