510(k) · Cleared
ClearedBonegen - TR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Lok Intl., Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Mar 16, 2006 as substantially equivalent to K011403 (Orthogen Corp., 2001) and 3 other predicates after a 41-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Mar 16, 2006
- Review
- 41 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K960978 (1996). 9 ancestors in all, the oldest K955096 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 1 generation backK030288 Polygraft Bone Graft SubstituteOsteobiologics, Inc. · 2003
- This deviceK060285 Bonegen - TRBio-Lok Intl., Inc. · 2006
- Descendant · cites it directly · 0 of its ownK102208 NanogenOrthogen, LLC · 2011
Most influential descendants
Showing 1 of 1 · See all- K102208NanogenOrthogen, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −2 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −1 | K030288 | Polygraft Bone Graft Substitute | Osteobiologics, Inc. | 2003 | — |
| 0 (this device) | K060285 | Bonegen - TR | Bio-Lok Intl., Inc. | 2006 | — |
| +1 | K102208 | Nanogen | Orthogen, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (4)
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 |
|---|---|---|---|
| * | K011403 | Surgiplaster Calcium Sulfate HemihydrateSummary page 1…entation material SUBSTANTIAL EQUIVALENCE: BoneGen-TR is substantially equivalent in design, function and intended use to Orthogen Corporation's SurgiPlaster cleared as K01 1403 on September 11, 2001 (tradename changed to Biol-ok International Inc.'s BoneGen on June 21, 2005). The only difference is the ad… | 2001 |
| * | K041324 | Calmatrix Calcium Sulfate Bone Graft BinderSummary page 1…d predicate device having substantially equivalent design, function and intended use is Lifecore Biomedical Inc.'s CalMatrix Calcium Sulfate Bone Graft Binder cleared as K041324 on June 19, 2004. This device, like BoneGen-TR, is a composite of calcium sulfate hernihydrate and an absorbable polymer. A third… | 2004 |
| * | K030288 | Polygraft Bone Graft SubstituteSummary page 1…, is a composite of calcium sulfate hernihydrate and an absorbable polymer. A third predicate device is OsteoBiologics, Inc.'s Polygraft Bone Graft Substitute cleared as K030288 on June 17, 2003. This device is substantially equivalent in function. The intended use of filling bony voids or gaps is equivale… | 2003 |
| * | K982865 | Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier KitSummary page 1…ning polymer, in addition to polyglycolide fibers and a surfactant. A fourth predicate device is Atrix Laboratories, Inc.'s Atrisorb Bioabsorbable GTR Barrier cleared as K982865 on September 8, 1998. This device utilizes the PLA absorbable polymer as a bone contacting and repair material, It differs in tha… | 1998 |
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 |
|---|---|---|---|
| K102208 | Nanogen | 2011 | 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 10 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K102208 (Orthogen, LLC, 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K011403.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
1. Oral Surgery: Post-extraction.
2. Periodontics: Infra-osseous defects.
3. Endodontics: Apioectomy, Root perforations, Open apices.
4. Implantology: Dehiscences, fenestrations, sinus lifts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060285: Bonegen - TR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060285
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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