# K030682: Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3

- Pathway: 510(k) (Traditional)
- Applicant: Bioform, Inc.
- Decided: Jun 27, 2003 after 114 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K852682 (1985). 10 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852682: Calcitite Bone Graft Mat/Oral & Maxillofacial Surg, Calcitek, Inc. (1985). 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”.
- K852742: Osteograf AR Alveolar Ridge Hydroxylapatite 18-40, Coors Biomedical Co. (1985) Summary page 1.
- K852765: HA-2000 Hydroxylapatite, Orthomatrix, Inc. (1985) Summary page 1.
- K992416: Perioglas- Bioglass Bone Graft Particulate, Usbiomaterials Corp. (1999) Summary page 1.
- K000149: Novabone-Bioglass Bone Graft Particulate, Usbiomaterials Corp. (2000)
- K952922: Biogran Bioactive Glass Synthetic Bone Graft Material, Orthovita Co. (1995) Summary page 1.
- K921468: Permamesh Hydroxylapatite Matrix, Ceramed Corp. (1992) Summary page 2.
- K862061: Osteograf/AR+ Permaridge Hydroxylapatite, 18-40, Coors Biomedical Co. (1986) Summary page 2.
- K910432: Hapset Hydroxylapatite Bone Graft Plaster, Lifecore Biomedical, Inc. (1991) Summary page 2.

## Most influential descendants
- K033398: Laryngeal Augmentation Implant (2003), 10 descendants of its own
- K060815: Juliesse Injectable Laryngeal Augmentation Implant (2006), 6 descendants of its own
- K070090: Radiesse Laryngeal Implant (2007), 5 descendants of its own
- K071663: VF Gel Plus (2008), 4 descendants of its own
- K080956: Modification to VF Gel Plus (2008), 3 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K030682
Methodology: https://510kreport.com/methodology