510(k) · Cleared
ClearedFM-02 Bone Graft Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthovita, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Oct 27, 2010 as substantially equivalent to K072184 (Orthovita, Inc., 2007) and 2 other predicates after a 54-day review. Its family tree reaches back 7 generations to 1996. 2 later devices descend from it.
- Decided
- Oct 27, 2010
- Review
- 54 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K960978 (1996). 21 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 5 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 4 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 3 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 2 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 1 generation backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- This deviceK102545 FM-02 Bone Graft SubstituteOrthovita, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK242280 Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss®…Stryker Spine · 2024
- Descendant · 2 generations on · 0 of its ownK261008 Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss®…Stryker Spine · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −6 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −5 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −4 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −3 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −2 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −1 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| 0 (this device) | K102545 | FM-02 Bone Graft Substitute | Orthovita, Inc. | 2010 | — |
| +1 | K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal… | Stryker Spine | 2024 | — |
| +2 | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K072184 | Vitoss Bioactive Foam Bone Graft SubstituteSummary page 1…ation Number: 888.3045 Device Class: Class 11 Product Code: MQV 3. Predicate Device(s) Vitoss Bioactive Foam Bone Graft Substitute (K072184) Vitoss Bioactive Foam Bone Graft Substitute STRIP and PACK (K08 1439) Vitoss Bioactive Foam Bone Graft Substitute STRIP and PACK… | 2007 |
| * | K081439 | Vitoss Bioactive Foam Pack Bone Graft SubstituteSummary page 1…Product Code: MQV 3. Predicate Device(s) Vitoss Bioactive Foam Bone Graft Substitute (K072184) Vitoss Bioactive Foam Bone Graft Substitute STRIP and PACK (K08 1439) Vitoss Bioactive Foam Bone Graft Substitute STRIP and PACK (K083033) 4. Device Description FM-02 Bone Graft Substitute is a res… | 2008 |
| * | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Summary page 1…ve Foam Bone Graft Substitute (K072184) Vitoss Bioactive Foam Bone Graft Substitute STRIP and PACK (K08 1439) Vitoss Bioactive Foam Bone Graft Substitute STRIP and PACK (K083033) 4. Device Description FM-02 Bone Graft Substitute is a resorbable porous bone void filler for the repair of bony defects. It is… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive… | 2024 | 1 |
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 14 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K242280 (Stryker Spine, 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K072184.
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. 2010, 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?
FM-02 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. FM-02 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
FM-02 Bone Graft Substitute is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102545: FM-02 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/K102545
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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