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 Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips
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 Aug 29, 2024 as substantially equivalent to K153608 (Orthovita, Inc., 2016) and 3 other predicates after a 27-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.
- Decided
- Aug 29, 2024
- Review
- 27 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K960978 (1996). 34 ancestors in all, the oldest K852682 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations between
- 3 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 2 generations backK103173 Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc. · 2011
- 1 generation backK153608 Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc. · 2016
- This deviceK242280 Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss®…Stryker Spine · 2024
- Descendant · cites it directly · 0 of its ownK261008 Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss®…Stryker Spine · 2026
Show all 9 generations
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 8 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 7 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 6 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 5 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 4 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 3 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 2 generations backK103173 Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc. · 2011
- 1 generation backK153608 Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc. · 2016
- This deviceK242280 Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss®…Stryker Spine · 2024
Most influential descendants
Showing 1 of 1 · See all- K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −8 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −7 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −6 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −5 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −4 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −3 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −2 | K103173 | Vitoss BA Bimodal Bioactive Bone Graft Substitute | Orthovita, Inc. | 2011 | — |
| −1 | K153608 | Vitoss BiModal Bone Graft Substitute Foam Strip | Orthovita, Inc. | 2016 | — |
| 0 (this device) | K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal… | Stryker Spine | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K153608 | Vitoss BiModal Bone Graft Substitute Foam StripSummary page 6…Compound (21 CFR 888.3045) Product Code: MQV Primary Predicate: Vitoss BiModal Bone Graft Substitute Foam Strip (K153608) Additional Predicates: Vitoss BA Bimodal Bioactive Bone Graft Substitute (K103173)… | 2016 |
| * | K103173 | Vitoss BA Bimodal Bioactive Bone Graft SubstituteSummary page 6…itute Foam Strip (K153608) Additional Predicates: Vitoss BA Bimodal Bioactive Bone Graft Substitute (K103173) Predicate Devices: FM-02 Bone Graft Substitute (K102545) Vitoss Bioactive Foam Bon… | 2011 |
| * | K102545 | FM-02 Bone Graft SubstituteSummary page 6…nal Predicates: Vitoss BA Bimodal Bioactive Bone Graft Substitute (K103173) Predicate Devices: FM-02 Bone Graft Substitute (K102545) Vitoss Bioactive Foam Bone Graft Substitute Pack, Vitoss Bioactive Foam Bone Graft… | 2010 |
| * | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Summary page 6…Bone Graft Substitute, Vitoss Foam Bone Graft Substitute, Vitoss Bone Graft Substitute Filled Canister, Vitoss Bone Graft Substitute (K083033) Page 1 of 3… | 2008 |
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 |
|---|---|---|---|
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive… | 2026 | 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 28 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 34 ancestors have a recall of any class.
- Of its descendants, K261008 (Stryker Spine, 2026) has gone furthest, with 0 descendants of its own.
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. 2024, 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?
Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip 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…
Read the full statement (469 words)
Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip
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 and posterolateral spine) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss® Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack
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 posterolateral fusion procedures) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister
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 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, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242280 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242280: 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 Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242280
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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