510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void Filler

K112383510(k) TraditionalCleared Feb 7, 2012173-day reviewClass II21 CFR 888.3045Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Skeletal Kinetics, LLC · MQV Filler, Bone Void, Calcium Compound

Cleared on Feb 7, 2012 as substantially equivalent to K060011 (Wrightmedicaltechnologyinc, 2006) and 2 other predicates after a 173-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it. It has been recalled 3 times.

Decided
Feb 7, 2012
Review
173 days
Class
Class II
Product code
MQV
Recalls
3
Predicates
3

Its longest line of descent runs back 3 generations to K011897 (2001). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 1 other ancestor2021: 1 descendant clearedK011897 · Norian SRS Bone Void Filler · Synthes (Usa) · 2001K030554 · Callos · Skeletal Kinetics, LLC · 2003K051123 · Callos Impact and Inject Bone Void Filler · Skeletal Kinetics, LLC · 2005 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K051123 · Callos Impact and Inject Bone Void Filler · Skeletal Kinetics, LLC · 2005 · recalledK030554 · Callos · Skeletal Kinetics, LLC · 2003K011897 · Norian SRS Bone Void Filler · Synthes (Usa) · 20010
  1. Root · 3 generations backK011897 Norian SRS Bone Void FillerSynthes (Usa) · 2001
  2. 2 generations backK030554 CallosSkeletal Kinetics, LLC · 2003
  3. 1 generation backK051123 Callos Impact and Inject Bone Void FillerSkeletal Kinetics, LLC · 2005 · Recalled
  4. This deviceK112383 Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone…Skeletal Kinetics, LLC · 2012
  5. Descendant · cites it directly · 0 of its ownK210193 DB-CompositeDimensional Bioceramics, LLC · 2021

Most influential descendants

Showing 1 of 1 · See all
  • K210193DB-CompositeDimensional Bioceramics, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K011897Norian SRS Bone Void FillerSynthes (Usa)2001—
−2K030554CallosSkeletal Kinetics, LLC2003—
−1K051123Callos Impact and Inject Bone Void FillerSkeletal Kinetics, LLC200517
0 (this device)K112383Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerSkeletal Kinetics, LLC2012—
+1K210193DB-CompositeDimensional Bioceramics, LLC2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
FIG. 1 — Lineage of K112383, 2001–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K060011Miig SR
Summary page 1
…es as required by 21 CFR 807.92 (a) (3) The subject device is substantially equivalent to the following legally marketed devices (predicates): MIIG® SR Bone Void Filler (K06001 1), PRO-DENSE T M Bone Graft Substitute (K07043 7) and Callos® Bone Void Filler (K051 123). Device Description as required by 21 C…
Wrightmedicaltechnologyinc2006—
*K070437Pro-Dense Bone Void Filler
Summary page 1
…ect device is substantially equivalent to the following legally marketed devices (predicates): MIIG® SR Bone Void Filler (K06001 1), PRO-DENSE T M Bone Graft Substitute (K07043 7) and Callos® Bone Void Filler (K051 123). Device Description as required by 21 CFR 807.92 (a) (4) Callos ProModel Bone Void Fill…
Wrightmedicaltechnologyinc2007—
*K051123Callos Impact and Inject Bone Void Filler
Summary page 1
…o the following legally marketed devices (predicates): MIIG® SR Bone Void Filler (K06001 1), PRO-DENSE T M Bone Graft Substitute (K07043 7) and Callos® Bone Void Filler (K051 123). Device Description as required by 21 CFR 807.92 (a) (4) Callos ProModel Bone Void Filler is a moldable and biocompatible calci…
Skeletal Kinetics, LLC200517

Also cleared against K060011: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K210193DB-CompositeDimensional Bioceramics, LLC20210

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 6, 2020Class IIZ-2630-2020Under Investigation by firmBone 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, 2020Class IIZ-2636-2020Under Investigation by firmBone 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, 2020Class IIZ-2631-2020Under Investigation by firmBone 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…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K210193 (Dimensional Bioceramics, LLC, 2021) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K060011.

How does its category compare?

All MQV devices

MQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · MQV

14in 2025

2007: 352008: 322009: 232010: 172011: 162012: 92013: 122014: 202015: 182016: 82017: 172018: 232019: 132020: 152021: 82022: 92023: 212024: 282025: 142026 (partial year): 5
2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007: 144 days median2008: 102 days median2009: 180 days median2010: 147 days median2011: 92 days median2012: 107 days median2013: 197 days median2014: 153 days median2015: 184 days median2016: 214 days median2017: 124 days median2018: 124 days median2019: 90 days median2020: 132 days median2021: 88 days median2022: 118 days median2023: 74 days median2024: 55 days median2025: 57 days median2026 (partial year): 96 days median
2007high 214 (2016) · low 55 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQV

1in 2025

2007: 52008: 32009: 12011: 62012: 32013: 22016: 12017: 12018: 22020: 12023: 32024: 22025: 12026 (partial year): 4
2007high 6 (2011) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQV

57in 2025

2007: 672008: 712009: 812010: 682011: 1142012: 1492013: 2232014: 1112015: 1252016: 1062017: 1072018: 862019: 652020: 1262021: 1012022: 472023: 1202024: 682025: 57
2007high 223 (2013) · low 47 (2022)2025

MAUDE reports naming product code MQV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735144567
200832102371
200923180181
201017147068
201116926114
201291073149
2013121972223
2014201530111
2015181840125
201682141106
2017171241107
201823124286
20191390065
2020151321126
20218880101
20229118047
202321743120
20242855268
20251457157
20265964—

What is it indicated for?

Callos® ProModel Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos ProModel 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 with bone during the healing process.

Indications for use as stated in the FDA summary.

Also cleared against K060011

1 other device cites the same predicate.

  • K070437Pro-Dense Bone Void FillerWrightmedicaltechnologyinc · 2007

More from Skeletal Kinetics, LLC

10 FDA decisions under this applicant name. See the company

  • K162864OsteoVation ImpactSkeletal Kinetics, LLC · 20177 recalls
  • K132211Skaffold NMX Bone Void FillerSkeletal Kinetics, LLC · 2014
  • K120354Beta-TCP GranulesSkeletal Kinetics, LLC · 2013
  • K111538Skaffold CisSkeletal Kinetics, LLC · 2011
  • K100986Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo VationSkeletal Kinetics, LLC · 201011 recalls

Recent decisions in MQV

The MQV category page

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  • K260364Device 300419 StripGeistlich Pharma AG · 2026
  • K252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd. · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K253524Adaptos®Fuse Bone GraftBiomendex OY · 2026

https://510kreport.com/device/K112383 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112383: Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) 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/K112383

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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