510(k) · Cleared
ClearedHatric, 6&7MM, 9&10MM, 11&12MM, 14&15MM, Models AR-13000B-07, -10, -12, -15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on May 12, 2004 after an 85-day review. The FDA summary names no predicate by number.
- Decided
- May 12, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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.
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?
The intended use for HATriCTM is that of a bone void filler or bone graft substitute in bony voids or gaps which are not intrinsic to the stability of the bony structure (i.e. extremities, pelvis, or spine). These bony voids and gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. HATriCTM may be used as a bone graft substitute for autograft or allograft when these grafts are undesirable or…
Read the full statement (202 words)
The intended use for HATriCTM is that of a bone void filler or bone graft substitute in bony voids or gaps which are not intrinsic to the stability of the bony structure (i.e. extremities, pelvis, or spine). These bony voids and gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. HATriCTM may be used as a bone graft substitute for autograft or allograft when these grafts are undesirable or unavailable.
When used for posterolateral fusions, the HATriCTM must be used with autograft bone material and the ratio of autograft bone material to HATriCTM must be in the range of 1.25cm3 to 2.4cm3 of autograft bone to 1cm3 of HATriCTM.
HATriCTM is a bone void filler or bone graft substitute that resorbs and is replaced with bone during the healing process. HATriCTM is not intended to be a load-bearing device. Therefore rigid fixation techniques may often be recommended.
In addition, when used with Arthrex Opening Osteotomy Systems' or substantially equivalent systems' plates and screws, HATriCTM is intended to be used as a bone void filler or bone graft substitute in femoral or tibial osteotomies. HATriCTM is to be used in association with adequate post-operative immobilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040381 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040381: Hatric, 6&7MM, 9&10MM, 11&12MM, 14&15MM, Models AR-13000B-07, -10, -12, -15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040381
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026