510(k) · Cleared
ClearedOsteoscaf
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Texas Innovative Medical Devices (Dba) Skeletal · LYC Bone Grafting Material, Synthetic
Cleared on Apr 20, 2011 as substantially equivalent to K082419 (Intra-Lock International, Inc., 2009) and 4 other predicates after a 293-day review. Its family tree reaches back 9 generations to 1987. 1 later device descends from it.
- Decided
- Apr 20, 2011
- Review
- 293 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K873689 (1987). 91 ancestors in all, the oldest K852682 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 5 generations between
- 3 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 2 generations backK060061 Stryker Injectable CementStryker Corp. · 2006
- 1 generation backK082419 Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
- This deviceK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
- Descendant · cites it directly · 0 of its ownK213260 CMFlexTMDimension Inx Corp. · 2022
Show all 9 generations
- Root · 9 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 8 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 7 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 6 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 5 generations backK021440 Bonesource HacStryker Instruments · 2002
- 4 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- 3 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 2 generations backK060061 Stryker Injectable CementStryker Corp. · 2006
- 1 generation backK082419 Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
- This deviceK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
Most influential descendants
Showing 1 of 1 · See all- K213260CMFlexTMDimension Inx Corp. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −8 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −7 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −6 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −5 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −4 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| −3 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| −2 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| −1 | K082419 | Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1 | Intra-Lock International, Inc. | 2009 | — |
| 0 (this device) | K101827 | Osteoscaf | Texas Innovative Medical Devices (Dba) Skeletal | 2011 | — |
| +1 | K213260 | CMFlexTM | Dimension Inx Corp. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 14 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K082419 | Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Summary page 1…ation: Class II Product Code: LYC Panel: Dental Predicate Devices: ReOSS h Intra-Lock International, Inc K082419 Bio-OSS m Geistlich Biomaterials, Inc K033815 Norian PDC Norian Corp… | 2009 |
| * | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenSummary page 1…Dental Predicate Devices: ReOSS h Intra-Lock International, Inc K082419 Bio-OSS m Geistlich Biomaterials, Inc K033815 Norian PDC Norian Corp K983 104 vitoss m Orthovita, Inc… | 2004 |
| * | K983104 | Norian Periodontal/Dental Cement (PDC)Summary page 1…International, Inc K082419 Bio-OSS m Geistlich Biomaterials, Inc K033815 Norian PDC Norian Corp K983 104 vitoss m Orthovita, Inc K(083033 HEALOS h Depuy Spine, Inc… | 1999 |
| * | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Summary page 1…aterials, Inc K033815 Norian PDC Norian Corp K983 104 vitoss m Orthovita, Inc K(083033 HEALOS h Depuy Spine, Inc K(081432 Intended Use: OsteosScafrm bone grafting… | 2008 |
| * | K081432 | Healos II Bone Graft SubstituteSummary page 1…K983 104 vitoss m Orthovita, Inc K(083033 HEALOS h Depuy Spine, Inc K(081432 Intended Use: OsteosScafrm bone grafting material is indicated for filling and/or augmenting intraoral/maxillofac… | 2008 |
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 |
|---|---|---|---|
| K213260 | CMFlexTM | 2022 | 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 24 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 91 ancestors have a recall of any class.
- Of its descendants, K213260 (Dimension Inx Corp., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
OsteoScaf bone grafting material is indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101827: Osteoscaf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101827
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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