510(k) · Cleared
ClearedStryker Injectable Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger Micro Implants · MQV Filler, Bone Void, Calcium Compound
Cleared on Dec 30, 2005 as substantially equivalent to K043334 (Stryker Instruments, 2005) and 2 other predicates after a 198-day review. Its family tree reaches back 7 generations to 1987. 3 later devices descend from it.
- Decided
- Dec 30, 2005
- Review
- 198 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K873689 (1987). 17 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 6 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 5 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 4 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 3 generations backK021440 Bonesource HacStryker Instruments · 2002
- 2 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- 1 generation backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- This deviceK051603 Stryker Injectable CementStryker Leibinger Micro Implants · 2005
- Descendant · cites it directly · 2 of its ownK140309 CranioplugOssdsign AB · 2014
- Descendant · 2 generations on · 1 of its ownK181539 OSSDSIGN CranioplugOssdsign AB · 2018
- Descendant · 3 generations on · 0 of its ownK253447 Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −6 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −5 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −4 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −3 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −2 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| −1 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| 0 (this device) | K051603 | Stryker Injectable Cement | Stryker Leibinger Micro Implants | 2005 | — |
| +1 | K140309 | Cranioplug | Ossdsign AB | 2014 | — |
| +2 | K181539 | OSSDSIGN Cranioplug | Ossdsign AB | 2018 | — |
| +3 | K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043334 | Bone Source Hac Rapid Setting CementSummary page 1…intrinsic to the stability of the bony structure. Substantial Equivalency Information Stryker%) Injectable Cement is substantially equivalent to legally marketed K043334 BoneSoure®g HAC Rapid Setting Cement, K041842 Norian SRS® Fast Set Putty, and K024336 Wright Medical MllG II.… | 2005 |
| * | K041842 | Norian SRS Fast Set PuttySummary page 1…ructure. Substantial Equivalency Information Stryker%) Injectable Cement is substantially equivalent to legally marketed K043334 BoneSoure®g HAC Rapid Setting Cement, K041842 Norian SRS® Fast Set Putty, and K024336 Wright Medical MllG II.… | 2004 |
| * | K024336 | Miig II Bone Graft SubstituteSummary page 1…mation Stryker%) Injectable Cement is substantially equivalent to legally marketed K043334 BoneSoure®g HAC Rapid Setting Cement, K041842 Norian SRS® Fast Set Putty, and K024336 Wright Medical MllG II. Public… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140309 | Cranioplug | 2014 | 2 |
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?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K140309 (Ossdsign AB, 2014) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K043334.
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?
Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, oraniofacial, spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051603: Stryker Injectable Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051603
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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