510(k) · Cleared
ClearedCross.Bone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
TriMed, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Dec 17, 2007 as substantially equivalent to K032268 (Biomatlante, 2003) and 2 other predicates after a 164-day review. Its family tree reaches back 8 generations to 1987.
- Decided
- Dec 17, 2007
- Review
- 164 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K873689 (1987). 24 ancestors in all, the oldest K861369 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 7 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 6 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 5 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 4 generations backK021440 Bonesource HacStryker Instruments · 2002
- 3 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- 2 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 1 generation backK060061 Stryker Injectable CementStryker Corp. · 2006
- This deviceK071876 Cross.BoneTriMed, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −7 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −6 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −5 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −4 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −3 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| −2 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| −1 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| 0 (this device) | K071876 | Cross.Bone | TriMed, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K032268 | MBCPSummary page 2…apatite and 40% P-tricalcium phosphate in the form of granules. It is used as a bone filler and for bone reconstruction. 111. Substantial Equivalence: K032268 - BIOMATLANTE, MBCP (Blocks) K051774 - BIOMATLANTE, MBCP (Granules) K060061_-Stryker Corp., Stryker Injectable Ceme… | 2003 |
| * | K051774 | MBCPSummary page 2…e form of granules. It is used as a bone filler and for bone reconstruction. 111. Substantial Equivalence: K032268 - BIOMATLANTE, MBCP (Blocks) K051774 - BIOMATLANTE, MBCP (Granules) K060061_-Stryker Corp., Stryker Injectable Cement Kelli Anderson Regulatory Affairs Spe… | 2006 |
| * | K060061 | Stryker Injectable CementSummary page 2…e filler and for bone reconstruction. 111. Substantial Equivalence: K032268 - BIOMATLANTE, MBCP (Blocks) K051774 - BIOMATLANTE, MBCP (Granules) K060061_-Stryker Corp., Stryker Injectable Cement Kelli Anderson Regulatory Affairs Specialist DEPARTMENT OF HE… | 2006 |
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 20 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 24 ancestors has a recall of any class.
- 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. 2007, 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?
Cross.Bone Blocks - CROSS.BONE BLOCK is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary. - Filling losses of bone material resulting from a fracture. - Filling losses of bone material after the resection of benign tumors or cysts Cross.Bone Bottles - CROSS.BONE BOTTLE is recommended for bone…
Read the full statement (205 words)
Cross.Bone Blocks - CROSS.BONE BLOCK is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
- Filling losses of bone material resulting from a fracture.
- Filling losses of bone material after the resection of benign tumors or cysts
Cross.Bone Bottles - CROSS.BONE BOTTLE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
Filling losses of bone material resulting from a fracture.
- Filling losses of bone material after the resection of benign tumors or cysts.
Cross.Bone Syringe -CROSS.BONE SYRINGE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
Bone filler following a fracture,
- Bone filler following resection of benign tumors or cysts,
When the cavity to be filled is large, it is recommended to cover it with a resorbable membrane.
Cross.Bone Wedge -CROSS.BONE WEDGE is recommended for tibial osteotomy with internal fixation, and necessarily in combination with an osteosynthesis procedure (metallic plates and screws).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071876 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071876: Cross.Bone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071876
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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