510(k) · Cleared
ClearedNorian SRS Fast Set Putty
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 Jul 23, 2004 as substantially equivalent to K011897 (Synthes (Usa), 2001) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 2001. 10 later devices descend from it.
- Decided
- Jul 23, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011897 (2001). 2 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK011897 Norian SRS Bone Void FillerSynthes (Usa) · 2001
- This deviceK041842 Norian SRS Fast Set PuttySynthes (Usa) · 2004
- Descendant · cites it directly · 3 of its ownK051603 Stryker Injectable CementStryker Leibinger Micro Implants · 2005
- Descendant · 2 generations on · 2 of its ownK140309 CranioplugOssdsign AB · 2014
- Descendant · cites it directly · 2 of its ownK071004 Osteocrete Bone Void FillerBone Solutions, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK212991 OsteoreviveBone Solutions, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK181539 OSSDSIGN CranioplugOssdsign AB · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K051603Stryker Injectable CementStryker Leibinger Micro Implants · 2005 · cites it directly3descendants
- K140309CranioplugOssdsign AB · 2014 · 2 generations on2descendants
- K071004Osteocrete Bone Void FillerBone Solutions, Inc. · 2009 · cites it directly2descendants
- K212991OsteoreviveBone Solutions, Inc. · 2022 · 2 generations on1descendant
- K181539OSSDSIGN CranioplugOssdsign AB · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011897 | Norian SRS Bone Void Filler | Synthes (Usa) | 2001 | — |
| 0 (this device) | K041842 | Norian SRS Fast Set Putty | Synthes (Usa) | 2004 | — |
| +1 | K051603 | Stryker Injectable Cement | Stryker Leibinger Micro Implants | 2005 | — |
| +2 | K140309 | Cranioplug | Ossdsign AB | 2014 | — |
| +1 | K071004 | Osteocrete Bone Void Filler | Bone Solutions, Inc. | 2009 | — |
| +2 | K212991 | Osteorevive | Bone Solutions, Inc. | 2022 | — |
| +3 | K181539 | OSSDSIGN Cranioplug | Ossdsign AB | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K011897 | Norian SRS Bone Void FillerSummary page 1…888.3045 - "Resorbable Calcium Salt Bone Void Filler Device" Predicate Device: Norian SRS Bone Void Filler, K01 1897 Norian CRS Fast Set Putty, K012589 Description of Device: Norian SRS Fast Set Putty is a sel… | 2001 |
| * | K012589 | Fast Set PuttySummary page 1…Device" Predicate Device: Norian SRS Bone Void Filler, K01 1897 Norian CRS Fast Set Putty, K012589 Description of Device: Norian SRS Fast Set Putty is a self-setting calcium phosphate cement… | 2002 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Fast Set Putty is indicated only for filling bony voids or gaps that are not intrinsic to the stability of the bony structure. The putty is to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SRS Fast Set Putty 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.
https://510kreport.com/device/K041842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041842: Norian SRS Fast Set Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041842
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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