510(k) · Cleared
ClearedVitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · MQV Filler, Bone Void, Calcium Compound
Cleared on Apr 24, 2026 as substantially equivalent to K242280 (Stryker Spine, 2024) after a 29-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Apr 24, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K960978 (1996). 35 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations between
- 3 generations backK103173 Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc. · 2011
- 2 generations backK153608 Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc. · 2016
- 1 generation backK242280 Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss®…Stryker Spine · 2024
- This deviceK261008 Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss®…Stryker Spine · 2026
Show all 10 generations
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 9 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 8 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 7 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 6 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 5 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 4 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 3 generations backK103173 Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc. · 2011
- 2 generations backK153608 Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc. · 2016
- 1 generation backK242280 Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss®…Stryker Spine · 2024
- This deviceK261008 Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss®…Stryker Spine · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −9 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −8 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −7 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −6 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −5 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −4 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −3 | K103173 | Vitoss BA Bimodal Bioactive Bone Graft Substitute | Orthovita, Inc. | 2011 | — |
| −2 | K153608 | Vitoss BiModal Bone Graft Substitute Foam Strip | Orthovita, Inc. | 2016 | — |
| −1 | K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal… | Stryker Spine | 2024 | — |
| 0 (this device) | K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal… | Stryker Spine | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Summary page 7…K261008 510(k) Summary: Vitoss Bone Graft Substitute Primary Predicate: K242280 Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss BiModal Bio… | 2024 |
| † | K253147 | FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft… | 2025 |
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 30 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 35 ancestors have a recall of any class.
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. 2026, 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?
These implants are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These implants are indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of…
Read the full statement (629 words)
These implants are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.
These implants are indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. These implants should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
These implants are intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine, which includes intervertebral disc space and posterolateral fusion procedures). When used in intervertebral body fusion procedures with an intervertebral body fusion device cleared by FDA for use with a bone void filler, Vitoss® can be mixed with saline, autogenous blood, bone marrow, and/or used on its own. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
The Vitoss® Foam family of products may be mixed with saline in addition to autogenous blood or bone marrow.
The Vitoss® Filled Canister is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This canister provides the surgeon with a convenient way to mix autogenous blood with Vitoss® and deliver the material to the orthopaedic surgical site.
Vitoss® Bioactive Foam Bone Graft 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. Vitoss® Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss® Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine, which includes intervertebral disc space and posterolateral fusion procedures) and may be combined with saline, autogenous blood, and/or bone marrow. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients 6 years old), are surgically created or the result of traumatic injury to the bone. When used in intervertebral body fusion procedures with an intervertebral body fusion device cleared by FDA for use with a bone void filler, Vitoss® can be mixed with saline, autogenous blood, bone marrow, and/or used on its own. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
These implants are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure.
They are indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
The implants are intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine) and may be combined with saline, autogenous blood, and/or bone marrow. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients 6 years old), are surgically created or the result of traumatic injury to the bone. When used in intervertebral body fusion procedures with an intervertebral body fusion device cleared by FDA for use with a bone void filler, Vitoss® can be mixed with saline, autogenous blood, bone marrow, and/or used on its own. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261008: Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261008
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026