510(k) · Cleared
Recalled · 2006Name Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Biotech · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 26, 2004 as substantially equivalent to K994337 (Orthovita Co., 2000) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 26, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K994337 (2000). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
- 1 generation backK021963 Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 2003 · Recalled
- This deviceK041421 Name Bone Void FillerStryker Biotech · 2004
- Descendant · cites it directly · 3 of its ownK051722 Tricos TBaxter Healthcare Corp · 2005
- Descendant · 2 generations on · 2 of its ownK073571 Tricos T Resorbable Bone SubstituteBaxter Healthcare Corporation · 2008
- Descendant · 2 generations on · 0 of its ownK081717 Tricos a Resorbable Bone SubstituteBaxter Healthcare Corp · 2008
- Descendant · 2 generations on · 0 of its ownK081721 Tricos a Resorbable SubstituteBaxter Healthcare Corp · 2008
Most influential descendants
Showing 4 of 4 · See all- K051722Tricos TBaxter Healthcare Corp · 2005 · cites it directly3descendants
- K073571Tricos T Resorbable Bone SubstituteBaxter Healthcare Corporation · 2008 · 2 generations on2descendants
- K081717Tricos a Resorbable Bone SubstituteBaxter Healthcare Corp · 2008 · 2 generations on0descendants
- K081721Tricos a Resorbable SubstituteBaxter Healthcare Corp · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita Co. | 2000 | — |
| −1 | K021963 | Biosorb Resorbable Void Filler | Sciences ET Bio Materiaux (Sbm) | 2003 | 1 |
| 0 (this device) | K041421 | Name Bone Void Filler | Stryker Biotech | 2004 | — |
| +1 | K051722 | Tricos T | Baxter Healthcare Corp | 2005 | — |
| +2 | K073571 | Tricos T Resorbable Bone Substitute | Baxter Healthcare Corporation | 2008 | — |
| +2 | K081717 | Tricos a Resorbable Bone Substitute | Baxter Healthcare Corp | 2008 | — |
| +2 | K081721 | Tricos a Resorbable Substitute | Baxter Healthcare Corp | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 2…e and physical characteristics of Stryker® TCP Putty are substantially equivalent to those found in one or more of the following predicate devices. K994337: VitossTM Scaffold Synthetic Cancellous Bone Void Filler (Orthovita, Inc.) K021963: BLOSORB® Resorbable Void Filler (Scien… | 2000 |
| * | K021963 | Biosorb Resorbable Void FillerSummary page 2…found in one or more of the following predicate devices. K994337: VitossTM Scaffold Synthetic Cancellous Bone Void Filler (Orthovita, Inc.) K021963: BLOSORB® Resorbable Void Filler (Sciences et Bio Materiaux) K010555: JAX T Bone Void Filler (Smith & Nephew, Inc.)… | 2003 |
| * | K010555 | JAXSummary page 2…K994337: VitossTM Scaffold Synthetic Cancellous Bone Void Filler (Orthovita, Inc.) K021963: BLOSORB® Resorbable Void Filler (Sciences et Bio Materiaux) K010555: JAX T Bone Void Filler (Smith & Nephew, Inc.) K020895: Allomatrix Putty (Wright Medical Technology, Inc.) Testing Sum… | 2003 |
| * | K020895 | Allomatrix Model# 86Summary page 2…Filler (Orthovita, Inc.) K021963: BLOSORB® Resorbable Void Filler (Sciences et Bio Materiaux) K010555: JAX T Bone Void Filler (Smith & Nephew, Inc.) K020895: Allomatrix Putty (Wright Medical Technology, Inc.) Testing Summary Laboratory testing and animal testing were provided to c… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051722 | Tricos T | 2005 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 16, 2006 | Not classified | Z-0254-2007 | Other | Lack of Labeling Precautions. Calstrux should not be used in combination with other products and the volume used should approximate the size of the defect. Adverse reactions have been reported with over filling the defect site or… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K051722 (Baxter Healthcare Corp, 2005) has gone furthest, with 3 descendants of its own.
- 25 other devices also cite its predicate K994337.
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?
TCP Putty is indicated as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. It should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
TCP Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, the tri-calcium phosphate scaffold is resorbed and replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041421: Name 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/K041421
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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