510(k) · Cleared
ClearedCMFlexTM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dimension Inx Corp. · LYC Bone Grafting Material, Synthetic
Cleared on Dec 30, 2022 as substantially equivalent to K101827 (Texas Innovative Medical Devices (Dba) Skeletal, 2011) after a 456-day review. Its family tree reaches back 10 generations to 1987.
- Decided
- Dec 30, 2022
- Review
- 456 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K873689 (1987). 92 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 10 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 6 generations between
- 3 generations backK060061 Stryker Injectable CementStryker Corp. · 2006
- 2 generations backK082419 Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
- 1 generation backK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
- This deviceK213260 CMFlexTMDimension Inx Corp. · 2022
Show all 10 generations
- Root · 10 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 9 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 8 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 7 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 6 generations backK021440 Bonesource HacStryker Instruments · 2002
- 5 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- 4 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 3 generations backK060061 Stryker Injectable CementStryker Corp. · 2006
- 2 generations backK082419 Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
- 1 generation backK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
- This deviceK213260 CMFlexTMDimension Inx Corp. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −9 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −8 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −7 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −6 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −5 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| −4 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| −3 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| −2 | K082419 | Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1 | Intra-Lock International, Inc. | 2009 | — |
| −1 | K101827 | Osteoscaf | Texas Innovative Medical Devices (Dba) Skeletal | 2011 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K101827 | OsteoscafSummary page 4…Grafting Material, Synthetic (21 CFR 872.3930) PRODUCT CODE LYC PRIMARY PREDICATE Trade name: OsteoScaf™ Common name: Bone Grafting Material, Synthetic 510(k) number: K101827 REFERENCE DEVICE Trade name: Easy-Graft® Common name: Bone Grafting Material, Synthetic 510(k) number: K131385 INDICATIONS FOR… | 2011 |
| † | K131385 | Easy-Graft | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 9 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 92 ancestors have a recall of any class.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include:
• Intrabony periodontal osseous defects
• Furcation defects
• Bony defects or bony deficiencies of the alveolar ridge
• Intraoral, maxillofacial, and mandibular augmentation
• Bony defects of the upper or lower jaw
• Filling of tooth extraction sites
• Sinus elevation grafting
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213260 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213260: CMFlexTM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213260
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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