510(k) · Cleared
ClearedBicera (TM) Resorbable Bone Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wiltrom Corporation Limited · MQV Filler, Bone Void, Calcium Compound
Cleared on Sep 18, 2012 as substantially equivalent to K032268 (Biomatlante, 2003) after a 533-day review. Its family tree reaches back 3 generations to 1999. 3 later devices descend from it.
- Decided
- Sep 18, 2012
- Review
- 533 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K990131 (1999). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 2 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 1 generation backK032268 MBCPBiomatlante · 2003
- This deviceK110949 Bicera (TM) Resorbable Bone SubstituteWiltrom Corporation Limited · 2012
- Descendant · cites it directly · 1 of its ownK171629 ABCcolla Bone GraftAcro Biomedical Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK212156 ABCcolla Bone MatrixAcro Biomedical Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK172237 Bicera Resorbable Bone SubstituteWiltrom Corporation Limited · 2018
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 |
|---|---|---|---|---|---|
| −3 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −2 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −1 | K032268 | MBCP | Biomatlante | 2003 | — |
| 0 (this device) | K110949 | Bicera (TM) Resorbable Bone Substitute | Wiltrom Corporation Limited | 2012 | — |
| +1 | K171629 | ABCcolla Bone Graft | Acro Biomedical Co., Ltd. | 2018 | — |
| +2 | K212156 | ABCcolla Bone Matrix | Acro Biomedical Co., Ltd. | 2021 | — |
| +1 | K172237 | Bicera Resorbable Bone Substitute | Wiltrom Corporation Limited | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K032268 | MBCPSummary page 2…KI I697Lfc t'ASE 2,f)t MBCPTM Bone Graft Substitute, K032268 7. Mandatory Performance Standard Class 11 Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler… | 2003 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171629 (Acro Biomedical Co., Ltd., 2018) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K032268.
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. 2012, 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?
BiceraTM Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. BiceraTM Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. BiceraTM Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110949 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110949: Bicera (TM) Resorbable Bone Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110949
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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