510(k) · Cleared
Recalled · Class II · 2019Opteform, Osteofil, Rti Allograft Paste IC, Rti Allograft Strip IC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Regeneration Technologies, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 16, 2005 after a 65-day review. The FDA summary names its predicate without a number. 16 later devices descend from it. It has been recalled 13 times.
- Decided
- Feb 16, 2005
- Review
- 65 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 13
- Predicates
- 0
16 later devices descend from it, 4 citing it directly.
- This deviceK043421 Opteform, Osteofil, Rti Allograft Paste IC, Rti Allograft Strip ICRegeneration Technologies, Inc. · 2005
- Descendant · cites it directly · 10 of its ownK081558 Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology · 2008
- Descendant · 2 generations on · 7 of its ownK091031 Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology · 2009
- Descendant · 3 generations on · 4 of its ownK110561 Fortross Bone Void FillerPioneer Surgical Technology · 2011
- Descendant · 4 generations on · 3 of its ownK141600 Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive…Pioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
- Descendant · 5 generations on · 2 of its ownK163621 Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology · 2008 · cites it directly10descendants
- K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology · 2009 · 2 generations on7descendants
- K110561Fortross Bone Void FillerPioneer Surgical Technology · 2011 · 3 generations on4descendants
- K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014 · 4 generations on3descendants
- K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043421 | Opteform, Osteofil, Rti Allograft Paste IC, Rti Allograft Strip IC | Regeneration Technologies, Inc. | 2005 | — |
| +1 | K081558 | Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CC | Pioneer Surgical Technology | 2008 | — |
| +2 | K091031 | Pioneer Surgical Nanoss BVF-E | Pioneer Surgical Technology | 2009 | — |
| +3 | K110561 | Fortross Bone Void Filler | Pioneer Surgical Technology | 2011 | — |
| +4 | K141600 | Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded Kit | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 2014 | — |
| +5 | K163621 | Vitoss Bioactive (BA) Injectable | Orthovita, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | — | Pro Osteon Implant 500R Resorbable Bone Void Filler Named without a submission number |
What descends from it? (16)
See all 164 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2019 | Class II | Z-1690-2019 | Environmental control | The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment. |
| Apr 26, 2019 | Class II | Z-1689-2019 | Environmental control | The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment. |
| Apr 26, 2019 | Class II | Z-1688-2019 | Environmental control | The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment. |
| Jan 23, 2017 | Class II | Z-1441-2017 | Labeling Change Control | Incorrect instructions for use (IFU) included. |
| Dec 6, 2013 | Class II | Z-0939-2014 | Other | RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past… |
| Oct 14, 2005 | Not classified | Z-0482-06 | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo… |
| Oct 14, 2005 | Not classified | Z-0488-06 | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo… |
| Oct 14, 2005 | Not classified | Z-0484-06 | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo… |
| Oct 14, 2005 | Not classified | Z-0485-06 | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo… |
| Oct 14, 2005 | Not classified | Z-0495-06 | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo… |
| Oct 14, 2005 | Not classified | Z-0483-06 | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo… |
| Oct 14, 2005 | Not classified | Z-0489-06 | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo… |
| Oct 14, 2005 | Not classified | Z-0501-06 | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo… |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081558 (Pioneer Surgical Technology, 2008) has gone furthest, with 10 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.
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 products are indicated for bony voids or gaps that are not intrinsic to the
stability of the bony structure. They are indicated to be placed into bony voids or
gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects
may be surgically created osseous defects or osseous defects created from traumatic
injury to the bone. The product provides a bone void filler that remodels into the
recipient's skeletal system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043421: Opteform, Osteofil, Rti Allograft Paste IC, Rti Allograft Strip IC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043421
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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