# K092087: Medtronic Dental TCP

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Dec 30, 2009 after 174 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: 6 generations back to K990131 (1999). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082917: Mastergraft Resorbable Ceramic Granules, Medtronic Sofamor Danek (2009) Summary page 1.
- K053022: Synthes (Usa) Chronos-Beta-TCP, Synthes (Usa) (2006) Summary page 1.
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005) Summary page 1.

## Indications for use
Medtronic Dental TOP is indicated as a bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure of the oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Dental TCP provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. Medtronic Dental TCP is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects. Procedures include: *Ridge augmentation *Sinus augmentation *Filling of cystic defects *Filling of extraction sites *Filling of lesions of periodontal origin *Craniofacial augmentation *Filling of defects of endodontic origin *Mandibular reconstruction *Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture *Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall Medtronic Dental TOP may be used alone, or in combination with saline, blood, bone marrow aspirate or platelet rich plasma (PRP). Medtronic Dental TOP may be mixed with autograft as a bone graft extender.

Source page: https://510kreport.com/device/K092087
Methodology: https://510kreport.com/methodology