510(k) · Cleared
ClearedMastergraft Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · LYC Bone Grafting Material, Synthetic
Cleared on Sep 17, 2008 as substantially equivalent to K071813 (Medtronic Sofamor Danek, 2007) and 4 other predicates after an 85-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it.
- Decided
- Sep 17, 2008
- Review
- 85 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K960978 (1996). 33 ancestors in all, the oldest K852682 (1985). 1 later device descends 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 backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 4 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 3 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 2 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- 1 generation backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- This deviceK081784 Mastergraft PuttyMedtronic Sofamor Danek · 2008
- Descendant · cites it directly · 0 of its ownK140374 Mastergraft PuttyMedtronic Sofamor Danek USA, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc. · 2014 · cites it directly0descendants
View 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 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −4 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −3 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −2 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| −1 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| 0 (this device) | K081784 | Mastergraft Putty | Medtronic Sofamor Danek | 2008 | — |
| +1 | K140374 | Mastergraft Putty | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 LYC? 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 LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K071813 | Mastergraft PuttySummary page 2…nce Documentation was provided which demonstrated MASTERGRAFT® Putty to be substantially equivalent to the previously cleared MASTERGRAFT® Putty (K071813), MSD Biphasic Calcium Bone Void Filler (K010701), Calcium Hydroxylapatite Implant (K030682), Osteon (K062834) and MBCP M… | 2007 |
| * | K010701 | Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void FillerSummary page 2…nstrated MASTERGRAFT® Putty to be substantially equivalent to the previously cleared MASTERGRAFT® Putty (K071813), MSD Biphasic Calcium Bone Void Filler (K010701), Calcium Hydroxylapatite Implant (K030682), Osteon (K062834) and MBCP MT (KO51885). MASTERGRAFT Putty… | 2001 |
| * | K030682 | Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Summary page 2…ally equivalent to the previously cleared MASTERGRAFT® Putty (K071813), MSD Biphasic Calcium Bone Void Filler (K010701), Calcium Hydroxylapatite Implant (K030682), Osteon (K062834) and MBCP MT (KO51885). MASTERGRAFT Putty… | 2003 |
| * | K062834 | Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050Summary page 2…the previously cleared MASTERGRAFT® Putty (K071813), MSD Biphasic Calcium Bone Void Filler (K010701), Calcium Hydroxylapatite Implant (K030682), Osteon (K062834) and MBCP MT (KO51885). MASTERGRAFT Putty K081784 Medtronic… | 2007 |
| * | K051885 | MBCP | 2005 |
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 |
|---|---|---|---|
| K140374 | Mastergraft Putty | 2014 | 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 12 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 33 ancestors has a recall of any class.
- Of its descendants, K140374 (Medtronic Sofamor Danek USA, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K071813.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, 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 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
What is it indicated for?
MASTERGRAFT® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Procedures include: Filling of…
Read the full statement (109 words)
MASTERGRAFT® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Procedures include:
Filling of periodontal defects
Filling of dental extraction sockets
Filling of cystic defects
Sinus lifts
Alveolar ridge augmentation
Oral/maxillofacial augmentation or reconstruction.
MASTERGRAFT® Putty may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081784 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081784: Mastergraft Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081784
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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