510(k) · Cleared
ClearedNorian SRS Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · MQV Filler, Bone Void, Calcium Compound
Cleared on Dec 20, 2001 after a 185-day review. The FDA summary names its predicate without a number. 35 later devices descend from it.
- Decided
- Dec 20, 2001
- Review
- 185 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 11 citing it directly.
- This deviceK011897 Norian SRS Bone Void FillerSynthes (Usa) · 2001
- Descendant · cites it directly · 11 of its ownK030554 CallosSkeletal Kinetics, LLC · 2003
- Descendant · cites it directly · 10 of its ownK041842 Norian SRS Fast Set PuttySynthes (Usa) · 2004
- Descendant · 2 generations on · 9 of its ownK051123 Callos Impact and Inject Bone Void FillerSkeletal Kinetics, LLC · 2005 · Recalled
- Descendant · 2 generations on · 3 of its ownK051603 Stryker Injectable CementStryker Leibinger Micro Implants · 2005
- Descendant · 2 generations on · 3 of its ownK042072 Callos CMF Bone Void FillerSkeletal Kinetics, LLC · 2004 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K030554CallosSkeletal Kinetics, LLC · 2003 · cites it directly11descendants
- K041842Norian SRS Fast Set PuttySynthes (Usa) · 2004 · cites it directly10descendants
- K051123Callos Impact and Inject Bone Void FillerSkeletal Kinetics, LLC · 2005 · 2 generations on9descendants
- K051603Stryker Injectable CementStryker Leibinger Micro Implants · 2005 · 2 generations on3descendants
- K042072Callos CMF Bone Void FillerSkeletal Kinetics, LLC · 2004 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011897 | Norian SRS Bone Void Filler | Synthes (Usa) | 2001 | — |
| +1 | K030554 | Callos | Skeletal Kinetics, LLC | 2003 | — |
| +1 | K041842 | Norian SRS Fast Set Putty | Synthes (Usa) | 2004 | — |
| +2 | K051123 | Callos Impact and Inject Bone Void Filler | Skeletal Kinetics, LLC | 2005 | 17 |
| +2 | K051603 | Stryker Injectable Cement | Stryker Leibinger Micro Implants | 2005 | — |
| +2 | K042072 | Callos CMF Bone Void Filler | Skeletal Kinetics, LLC | 2004 | 10 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | — | Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler Named without a submission number | |
| * | — | Pro Osteon® S00R Resorbable Bone Graft Substitute Named without a submission number |
What descends from it? (35)
See all 3511 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030554 | Callos | 2003 | 11 |
| K041842 | Norian SRS Fast Set Putty | 2004 | 10 |
| K071004 | Osteocrete Bone Void Filler | 2009 | 2 |
| K082498 | Graftys HBS | 2009 | 2 |
| K130703 | Vivorte BVF | 2013 | 1 |
| K131133 | Vivorte BVF Lite | 2013 | 1 |
| K070220 | Osteofix Bone Void Filler | 2007 | 0 |
| K060408 | Norian SRS Bone Void Filler | 2006 | 0 |
| K041089 | Oss Bone Graft System and Oss Rapidset Bone Graft System | 2004 | 0 |
| K033611 | Calcigen -Nap Bone Void Filler | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030554 (Skeletal Kinetics, LLC, 2003) has gone furthest, with 11 descendants of its own.
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?
Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011897 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011897: Norian SRS Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011897
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026