510(k) · Cleared
ClearedMerries Uni-Osteo, Model CS30250-CS10102
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merries International, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Sep 29, 2005 as substantially equivalent to K963587 (Wrightmedicaltechnologyinc, 1997) and 2 other predicates after a 97-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Sep 29, 2005
- Review
- 97 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K963587 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK963587 Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)Wrightmedicaltechnologyinc · 1997
- This deviceK051698 Merries Uni-Osteo, Model CS30250-CS10102Merries International, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963587 | Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision) | Wrightmedicaltechnologyinc | 1997 | — |
| 0 (this device) | K051698 | Merries Uni-Osteo, Model CS30250-CS10102 | Merries International, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K963587 | Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)Summary page 2…TEO Pellets Bone Graft Substitute is substantially equivalent in base materials, function and intended use to the following devices: * OsteosetTM Pellets (K963587, K963562) Manufactured by Wright Medical Technology, Inc. * JaxTM(K010555) Manufactured by Smith &… | 1997 |
| * | K963562 | Wright Plaster of Paris PelletsSummary page 2…ts Bone Graft Substitute is substantially equivalent in base materials, function and intended use to the following devices: * OsteosetTM Pellets (K963587, K963562) Manufactured by Wright Medical Technology, Inc. * JaxTM(K010555) Manufactured by Smith & Nephew,… | 1997 |
| * | K010555 | JAXSummary page 2…n and intended use to the following devices: * OsteosetTM Pellets (K963587, K963562) Manufactured by Wright Medical Technology, Inc. * JaxTM(K010555) Manufactured by Smith & Nephew, Inc. 10. Material: The raw material, calcium sulfate, conforms to the requirements o… | 2003 |
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?
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K963587.
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?
Merries UNI-OSTEO pellets are used to fill bony defects which may be surgically created voids or from traumatic injury to the bone. The product is indicated to be packed into bony defects of the skeletal system which is not intrinsic to the stability of the bony structure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051698: Merries Uni-Osteo, Model CS30250-CS10102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051698
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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