510(k) · Cleared
ClearedOssaplast Ortho
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ossacur AG · MQV Filler, Bone Void, Calcium Compound
Cleared on Mar 29, 2005 as substantially equivalent to K014156 (Curasan AG, 2002) and 2 other predicates after a 39-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Mar 29, 2005
- Review
- 39 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K014156 (2002). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK014156 Cerasorb OrthoCurasan AG · 2002
- 1 generation backK042305 Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML…Ossacur AG · 2004
- This deviceK050416 Ossaplast OrthoOssacur AG · 2005
- Descendant · cites it directly · 0 of its ownK051047 Colloss E Bone Void FillerOssacur AG · 2006
Most influential descendants
Showing 1 of 1 · See all- K051047Colloss E Bone Void FillerOssacur AG · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K014156 | Cerasorb Ortho | Curasan AG | 2002 | — |
| −1 | K042305 | Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221… | Ossacur AG | 2004 | — |
| 0 (this device) | K050416 | Ossaplast Ortho | Ossacur AG | 2005 | — |
| +1 | K051047 | Colloss E Bone Void Filler | Ossacur AG | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K014156 | Cerasorb OrthoSummary page 1…filler device, §888.3045 (Product Code: MQV) C. Predicate Devices Trade Name: Cerasorb®ORTHO (K014156) Trade Name: Cerasorb® M ORTHO (K040216) Trade Name: OSSAPLAST TM O… | 2002 |
| * | K040216 | Cerasorb M OrthoSummary page 1…oduct Code: MQV) C. Predicate Devices Trade Name: Cerasorb®ORTHO (K014156) Trade Name: Cerasorb® M ORTHO (K040216) Trade Name: OSSAPLAST TM ORTHO (K042305) D. Device Description OSSAPLAST ORTHO (1… | 2004 |
| * | K042305 | Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221 901…Summary page 1…Cerasorb®ORTHO (K014156) Trade Name: Cerasorb® M ORTHO (K040216) Trade Name: OSSAPLAST TM ORTHO (K042305) D. Device Description OSSAPLAST ORTHO (1000- 2000 pm) is a synthetic, implantable, resorbable, rad… | 2004 |
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 |
|---|---|---|---|
| K051047 | Colloss E Bone Void Filler | 2006 | 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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K051047 (Ossacur AG, 2006) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K014156.
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?
OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050416: Ossaplast Ortho.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050416
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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