510(k) · Cleared
ClearedOsteo-Link Bone Void Filler Pellets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promed Advance Technology Co., Ltd. · MQV Filler, Bone Void, Calcium Compound
Cleared on Jul 3, 2006 as substantially equivalent to K963562 (Wrightmedicaltechnologyinc, 1997) after a 101-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Jul 3, 2006
- Review
- 101 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963562 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- This deviceK060809 Osteo-Link Bone Void Filler PelletsPromed Advance Technology Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK083279 Caltrix Resorbable Bone Void FillerAg Digital Technology Corp. · 2009
Most influential descendants
Showing 1 of 1 · See all- K083279Caltrix Resorbable Bone Void FillerAg Digital Technology Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | 1997 | — |
| 0 (this device) | K060809 | Osteo-Link Bone Void Filler Pellets | Promed Advance Technology Co., Ltd. | 2006 | — |
| +1 | K083279 | Caltrix Resorbable Bone Void Filler | Ag Digital Technology Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K963562 | Wright Plaster of Paris PelletsSummary page 1…Regulation Number: 21 CFR 888.3045 4. Predicate Device: The predicate device is the * Wright Plaster of paris pellets(K963562) marketed by WRIGHT MEDICAL TECHNOLOGY, INC. 5. Device Description: Osteo-Link Bone Void Filler Pelle… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083279 | Caltrix Resorbable Bone Void Filler | 2009 | 0 |
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?
Osteo-Link Bone Void Filler Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These pellets are indicated to be gently packed into bony voids or gap of the skeletal system; such as the extremities, spine and pelvis. Theses defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide the 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/K060809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060809: Osteo-Link Bone Void Filler Pellets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060809
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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