# K101827: Osteoscaf

- Pathway: 510(k) (Traditional)
- Applicant: Texas Innovative Medical Devices (Dba) Skeletal
- Decided: Apr 20, 2011 after 293 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: 9 generations back to K873689 (1987). 91 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082419: Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1, Intra-Lock International, Inc. (2009) Summary page 1.
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen, Geistlich-Pharma (2004) Summary page 1.
- K983104: Norian Periodontal/Dental Cement (PDC), Norian Corp. (1999) Summary page 1.
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute, Orthovita, Inc. (2008) Summary page 1.
- K081432: Healos II Bone Graft Substitute, Depuy Spine, Inc. (2008) Summary page 1.

## Most influential descendants
- K213260: CMFlexTM (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K101827
Methodology: https://510kreport.com/methodology