510(k) · Cleared
ClearedApatight HA-Bone Graft Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cerabio, LLC · MQV Filler, Bone Void, Calcium Compound
Cleared on May 23, 2002 as substantially equivalent to K990131 (Interpore Cross Intl., 1999) and 1 other predicate after a 171-day review. Its family tree reaches back 2 generations to 1996. 4 later devices descend from it.
- Decided
- May 23, 2002
- Review
- 171 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960978 (1996). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 1 generation backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- This deviceK013960 Apatight HA-Bone Graft SubstituteCerabio, LLC · 2002
- Descendant · cites it directly · 3 of its ownK030178 Calcigen Psi Bone Graft SubstituteBiomet, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK032286 Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc. · 2003
- Descendant · 3 generations on · 0 of its ownK063346 Pro Osteon 500REbi, L.P. · 2007
- Descendant · 2 generations on · 0 of its ownK050490 Osmosys Calcium Phosphate Ceramic Bone FillerMedicrea · 2005
Most influential descendants
Showing 4 of 4 · See all- K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc. · 2003 · cites it directly3descendants
- K032286Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc. · 2003 · 2 generations on1descendant
- K063346Pro Osteon 500REbi, L.P. · 2007 · 3 generations on0descendants
- K050490Osmosys Calcium Phosphate Ceramic Bone FillerMedicrea · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −1 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| 0 (this device) | K013960 | Apatight HA-Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| +1 | K030178 | Calcigen Psi Bone Graft Substitute | Biomet, Inc. | 2003 | — |
| +2 | K032286 | Calcigen Psi Bone Graft Substitute | Biomet Orthopedics, Inc. | 2003 | — |
| +3 | K063346 | Pro Osteon 500R | Ebi, L.P. | 2007 | — |
| +2 | K050490 | Osmosys Calcium Phosphate Ceramic Bone Filler | Medicrea | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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? (2)
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 |
|---|---|---|---|
| * | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft SubstituteSummary page 1…ne Graft Substitute Classification Name Filler, Calcium Sulfate Preformed Pellets Equivalent Devices Pro Osteon 500R Resorbable Bone Graft Substitute (Interpore Cross, K990131, K980817) Device Description Apatight-HA Bone Graft Substitute is a porous hydroxyapatite bone graft substitute for the repair… | 1999 |
| * | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…Summary page 1…Substitute Classification Name Filler, Calcium Sulfate Preformed Pellets Equivalent Devices Pro Osteon 500R Resorbable Bone Graft Substitute (Interpore Cross, K990131, K980817) Device Description Apatight-HA Bone Graft Substitute is a porous hydroxyapatite bone graft substitute for the repair of bony d… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030178 | Calcigen Psi Bone Graft Substitute | 2003 | 3 |
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 6 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K030178 (Biomet, Inc., 2003) has gone furthest, with 3 descendants of its own.
- 17 other devices also cite its predicate K990131.
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?
Apatight-HA Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight—HA is intended to be gently packed 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 resorbs and is replaced with bone during the healing process.
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/K013960 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013960: Apatight HA-Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013960
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026