510(k) · Cleared
ClearedBio-Scaffold Bioscaff Alvelac Resobable Scaffold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioscaffold International Pte, Ltd. · LYC Bone Grafting Material, Synthetic
Cleared on Apr 14, 2008 as substantially equivalent to K993610 (Osteogenics Biomedical, Inc., 2000) and 1 other predicate after a 69-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.
- Decided
- Apr 14, 2008
- Review
- 69 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973594 (1997). 5 ancestors in all, the oldest K955838 (1996). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK973594 Gore Resolut XT Regenerative MaterialW. L. Gore & Associates, Inc. · 1997
- 1 generation backK993610 Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250Osteogenics Biomedical, Inc. · 2000
- This deviceK080308 Bio-Scaffold Bioscaff Alvelac Resobable ScaffoldBioscaffold International Pte, Ltd. · 2008
- Descendant · cites it directly · 2 of its ownK082419 Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
- Descendant · cites it directly · 1 of its ownK090083 Cytoflex Resorb, Model C03-0010 Through C03-090Unicare Biomedical, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK253317 Cytrans™ ElashieldGC America, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK213260 CMFlexTMDimension Inx Corp. · 2022
Most influential descendants
Showing 5 of 5 · See all- K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009 · cites it directly2descendants
- K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011 · 2 generations on1descendant
- K090083Cytoflex Resorb, Model C03-0010 Through C03-090Unicare Biomedical, Inc. · 2009 · cites it directly1descendant
- K253317Cytrans™ ElashieldGC America, Inc. · 2026 · 2 generations on0descendants
- K213260CMFlexTMDimension Inx Corp. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973594 | Gore Resolut XT Regenerative Material | W. L. Gore & Associates, Inc. | 1997 | — |
| −1 | K993610 | Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250 | Osteogenics Biomedical, Inc. | 2000 | — |
| 0 (this device) | K080308 | Bio-Scaffold Bioscaff Alvelac Resobable Scaffold | Bioscaffold International Pte, Ltd. | 2008 | — |
| +1 | K082419 | Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1 | Intra-Lock International, Inc. | 2009 | — |
| +2 | K101827 | Osteoscaf | Texas Innovative Medical Devices (Dba) Skeletal | 2011 | — |
| +1 | K090083 | Cytoflex Resorb, Model C03-0010 Through C03-090 | Unicare Biomedical, Inc. | 2009 | — |
| +2 | K253317 | Cytrans™ Elashield | GC America, Inc. | 2026 | — |
| +3 | K213260 | CMFlexTM | Dimension Inx Corp. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K993610 | Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250Summary page 1…3234 6 4 th Street Laakarinkatu 2 Lubbock, TX 79413 FIN-33520, Tampere USA Finland K993610 K033074 510(k) for BioscaffTM Alvelac TM Page 1… | 2000 |
| * | K033074 | Inion GTR Biodegradable Membrane SystemSummary page 1…Laakarinkatu 2 Lubbock, TX 79413 FIN-33520, Tampere USA Finland K993610 K033074 510(k) for BioscaffTM Alvelac TM Page 1 bi:;'-~s… | 2004 |
What descends from it? (5)
2 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)
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 11 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K082419 (Intra-Lock International, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K993610.
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?
Bio-Scaffold Bioscaff Alvelac Scaffold is a bioabsorbable implantable matrix intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and conservation of alveolar bone height and volume, ridge and extraction site augmentation, sinus lifts, and treatment of associated cystic defects. It is also intended for use as a grafting material containment matrix.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080308: Bio-Scaffold Bioscaff Alvelac Resobable Scaffold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080308
Report an extraction error
Are you the manufacturer?
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