510(k) · Cleared
ClearedCalcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioform, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Jun 27, 2003 as substantially equivalent to K852682 (Calcitek, Inc., 1985) and 8 other predicates after a 114-day review. Its family tree reaches back 2 generations to 1985. 15 later devices descend from it.
- Decided
- Jun 27, 2003
- Review
- 114 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 2 generations to K852682 (1985). 10 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK852682 Calcitite Bone Graft Mat/Oral & Maxillofacial SurgCalcitek, Inc. · 1985
- 1 generation backK992416 Perioglas- Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1999
- This deviceK030682 Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc. · 2003
- Descendant · cites it directly · 10 of its ownK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- Descendant · 2 generations on · 6 of its ownK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 5 of its ownK070090 Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK071663 VF Gel PlusCoapt Systems, Inc. · 2008
- Descendant · 3 generations on · 3 of its ownK080956 Modification to VF Gel PlusCoapt Systems, Inc. · 2008
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K033398Laryngeal Augmentation ImplantBioform, Inc. · 2003 · cites it directly10descendants
- K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · 2 generations on6descendants
- K070090Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007 · 3 generations on5descendants
- K071663VF Gel PlusCoapt Systems, Inc. · 2008 · 2 generations on4descendants
- K080956Modification to VF Gel PlusCoapt Systems, Inc. · 2008 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852682 | Calcitite Bone Graft Mat/Oral & Maxillofacial Surg | Calcitek, Inc. | 1985 | — |
| −1 | K992416 | Perioglas- Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1999 | — |
| 0 (this device) | K030682 | Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3 | Bioform, Inc. | 2003 | — |
| +1 | K033398 | Laryngeal Augmentation Implant | Bioform, Inc. | 2003 | — |
| +2 | K060815 | Juliesse Injectable Laryngeal Augmentation Implant | Bioform Medical, Inc. | 2006 | 1 |
| +3 | K070090 | Radiesse Laryngeal Implant | Bioform Medical, Inc. | 2007 | — |
| +2 | K071663 | VF Gel Plus | Coapt Systems, Inc. | 2008 | — |
| +3 | K080956 | Modification to VF Gel Plus | Coapt Systems, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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? (9)
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 |
|---|---|---|---|
| * | K852682 | Calcitite Bone Graft Mat/Oral & Maxillofacial Surg Our reading of the summary gave K882682, FDA’s number for Compat Enteral Delivery System (Sandoz Nutrition). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Calcitite”. | 1985 |
| * | K852742 | Osteograf AR Alveolar Ridge Hydroxylapatite 18-40Summary page 1…apatite Implant: K882682 Calcitite Calcitek, Inc,, 4125-B Sorrento Valley Boulevard, San Diego, CA 92 121 IC852742 Osteograf AR Alveolar Ridge Hydroxylapatite 18-40 Coors BiQmedicalCampany, 12860 West Cedar Drive,… | 1985 |
| * | K852765 | HA-2000 HydroxylapatiteSummary page 1…Osteograf AR Alveolar Ridge Hydroxylapatite 18-40 Coors BiQmedicalCampany, 12860 West Cedar Drive, Lakewood, CO 80228 K852765 HA-2000 Orthomatrix, Inc., 6968 Sicrra Court, Dublin CA 94568 K9924 16 Perioglas-BioGlass… | 1985 |
| * | K992416 | Perioglas- Bioglass Bone Graft ParticulateSummary page 1…0 West Cedar Drive, Lakewood, CO 80228 K852765 HA-2000 Orthomatrix, Inc., 6968 Sicrra Court, Dublin CA 94568 K9924 16 Perioglas-BioGlass Bone Graft Particulate U,S, Biomaterials Corp,, One Progrcss Boulevard, Alachua,… | 1999 |
| * | K000149 | Novabone-Bioglass Bone Graft Particulate | 2000 |
| * | K952922 | Biogran Bioactive Glass Synthetic Bone Graft MaterialSummary page 1…KO00 149 Novabone-Bioglass Bone Graft Particulate U.S.Biomaterials Corp., One Progress Boulevard, Alachua, FL 32615 K952922 Biogran Bioactive Glass Synthetic Bone Graft Material Calcium Hydroxylapati… | 1995 |
| * | K921468 | Permamesh Hydroxylapatite MatrixSummary page 2…June 25,2003 Orthovita Co., 212 Carnegie Center Drive, Suite 206, Princeton, NJ 08540 K921468 PermaMesh Hydroxylapatite Matrix CeraMed Corp., 12860 West Cedar Drive. Lakewood,… | 1992 |
| * | K862061 | Osteograf/AR+ Permaridge Hydroxylapatite, 18-40Summary page 2…08540 K921468 PermaMesh Hydroxylapatite Matrix CeraMed Corp., 12860 West Cedar Drive. Lakewood, CO 80228 K862061 Ostcograf/AR+ Permaridge Hydroxylapatite, 18-40 Coors Biomedical Co., 12860 West Cedar Drive, Suite… | 1986 |
| * | K910432 | Hapset Hydroxylapatite Bone Graft PlasterSummary page 2…graf/AR+ Permaridge Hydroxylapatite, 18-40 Coors Biomedical Co., 12860 West Cedar Drive, Suite 2 10, Lakewood, CO 80228 K9 10432 HAPSET Hydroxylapatite Bonc Graft Plaster Lifecore Biomedical, Inc., 1050 Connecticut Avenue, N.W.… | 1991 |
What descends from it? (15)
See all 154 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 18 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K033398 (Bioform, Inc., 2003) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K852682.
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?
BioForm’s Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including:
Periodontal Defects
Ridge Augmentation
Extraction Sites
Craniofacial Augmentation
Cystic Defects
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030682 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030682: Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030682
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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