510(k) · Cleared
ClearedDSM Biomedical Calcium Phosphate Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dsm Biomedical · MQV Filler, Bone Void, Calcium Compound
Cleared on Mar 21, 2023 as substantially equivalent to K173362 (Kensey Nash Corporation Dba Dsm Biomedical, 2018) after a 74-day review. Its family tree reaches back 9 generations to 1987.
- Decided
- Mar 21, 2023
- Review
- 74 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K873689 (1987). 19 ancestors in all, the oldest K861369 (1986). No later device cites it as a predicate yet.
- Root · 9 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 5 generations between
- 3 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 2 generations backK060061 Stryker Injectable CementStryker Corp. · 2006
- 1 generation backK173362 DSM Biomedical Calcium Phosphate CementKensey Nash Corporation Dba Dsm Biomedical · 2018
- This deviceK230054 DSM Biomedical Calcium Phosphate CementDsm Biomedical · 2023
Show all 9 generations
- Root · 9 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 8 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 7 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 6 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 5 generations backK021440 Bonesource HacStryker Instruments · 2002
- 4 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- 3 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 2 generations backK060061 Stryker Injectable CementStryker Corp. · 2006
- 1 generation backK173362 DSM Biomedical Calcium Phosphate CementKensey Nash Corporation Dba Dsm Biomedical · 2018
- This deviceK230054 DSM Biomedical Calcium Phosphate CementDsm Biomedical · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −8 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −7 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −6 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −5 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −4 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| −3 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| −2 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| −1 | K173362 | DSM Biomedical Calcium Phosphate Cement | Kensey Nash Corporation Dba Dsm Biomedical | 2018 | — |
| 0 (this device) | K230054 | DSM Biomedical Calcium Phosphate Cement | Dsm Biomedical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (1)
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 |
|---|---|---|---|
| * | K173362 | DSM Biomedical Calcium Phosphate CementSummary page 4…Panel: Orthopedic III. PREDICATE DEVICE Substantial equivalence is claimed to the following device: • DSM Biomedical Calcium Phosphate Cement, K173362 IV. DEVICE DESCRIPTION Page 1 of 6 === P… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 36 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 19 ancestors has a recall of any class.
- 1 other device also cites its predicate K173362.
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. 2023, this device’s year, is highlighted.
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?
DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created, or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement cured in situ provides an open void/gap filler that can…
Read the full statement (126 words)
DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created, or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230054: DSM Biomedical Calcium Phosphate Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230054
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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